QMS - of A Company

DOCUMENT NO: EAC/TF-MED/QMS/FD/COM/N1R0
COMPENDIUM OF QUALITY MANAGEMENT

SYSTEM (QMS) TECHNICAL DOCUMENTS
FOR HARMONIZATION OF
MEDICINE REGULATION IN THE
EAST AFRICAN COMMUNITY
VERSION SEPTEMBER 2014

DOCUMENTS DEVELOPMENT HISTORY
STEPS DATE
Development of draft harmonized technical 1st August 2012 to 19th July 2013
documents for Good Manufacturing Practices
(GMP) for the East African Community
Medicines Regulatory Harmonization Initiative
Draft harmonized technical documents 2nd to 3rd September 2013
approved by the Steering Committee
Release of draft harmonized technical 16th September 2013 to
documents for Public Consultation 29th October 2013
End of National Consultation 28th February 2014
(deadline for comments)
Incorporation of national stakeholders inputs 13th to 17th January 2014
by EAC Secretariat in collaboration with EAC
Partner States
Release of revised technical documents for 20th January 2014
regional and international consultation
End of regional and international consultation 28th February 2014
(deadline for comments)
Draft technical documents reviewed and 12th March 2014
adopted by EAC Technical Working Group on
Medicines and Food Safety
Draft technical documents adopted by the 14th March 2014
18th EAC Sectoral Committee on Health
Draft technical documents finalized by 1st to 4th April 2014
EAC Secretariat in collaboration with
EAC Partner States
Final technical documents approved by the 17th April 2014
9th EAC Sectoral Council on Health
Date for coming into effect 17th April 2014
i
FOREWORD
This Compendium has been developed to The EAC Secretariat also recognizes
provide guidance to EAC Partners States the important contribution of the Clinton
National Medicines Regulatory Authorities Health Access Initiative (CHAI) in the
to implement Quality Management System conceptualization of the African Medicines
(QMS). Regulatory Harmonization (AMRH) Initiative.
I would like to thank members of the
The Compendium was compiled by the East Technical Working Group (EWG) on Quality
African Community (EAC) Technical Working Management System (QMS) and the WHO
Group (EWG) on QMS. The EWG relied on expert who contributed to the successful
available International Standards (ISO 9000 development of the first edition of these
series, ISO/IEC 17020 and ISO/IEC 17025), Quality Management System documents.
WHO guidelines, and other experiences from
other medicine regulatory authorities. I also wish to thank the staff of EAC
Secretariat for their dedicated work and
EAC Secretariat is highly indebted to African coordination of the implementation of the
Medicines Regulatory Harmonization EAC Medicines Regulatory Harmonization
(AMRH) program partners, Bill and Melinda (MRH) Project.
Gates Foundation (BMGF), the World Bank
and the United Kingdom Department for I also acknowledge the oversight role of the
International Development (DFID) for their EAC Partner States Ministries responsible
financial assistance; and African Union New for Health, Ministries responsible for EAC
Partnership for Africa’s Development (AU- affairs and the EAC MRH Project Steering
NEPAD) for high level advocacy. Committee.
Finally, I would like to acknowledge regional

stakeholders in Sectors of health, trade and
industry in EAC for their valuable contribution
into the development of this Compendium.
Ambassador Dr. Richard Sezibera

Secretary General
EAC Secretariat

ii
PREFACE
The “Compendium of Quality Management The East African Community Quality

System Technical Documents for Management System Requirement
Harmonization of Medicines Regulation have been developed to enable uniform
in The East African Community, 2014” implementation of the Quality Management
is an EAC publication which sets out the System (QMS) that applies to the regulation
implementation of Quality Management of the quality and safety of various
System (QMS) within EAC NMRAs. pharmaceutical products and services by the
National Medicines Regulatory Authorities of
This Compendium contains five parts namely: the East African Community Partner States.
1. The East African Community This document is mainly based on ISO

Quality Management System 9001:2008 - “Quality Management systems
Requirement, 2014 requirements”.
2. The EAC Guidelines for the The EAC Guidelines for the implementation
implementation of Quality of Quality Management System
Management System Requirements has been developed to enable
Requirements for the Regulation uniform implementation of the EAC Quality
of Medicines, Cosmetics, Medical Management System (QMS) requirements by
Devices and Diagnostics, 2014 the EAC Partner States NMRAs.
3. The Model Manual on the The Model Manual on the Implementation

Implementation of East African of EAC Quality Management System
Community Quality Management Requirements has been developed to
System Requirements for define and describe the quality management
the Regulation of Medicines, system, authorities and responsibilities of
Cosmetics, Medical Devices and the management personnel involved in
Diagnostics, 2014 the operation of the system, and provide
references to general procedures for all
4. The Mandatory Documented activities of the entire NMRA, based on the
Procedures; and EAC QMS Requirements.
5. Code of Conduct for Partner The mandatory documented procedures

States National Medicines describe the quality management system
Regulatory Authorities, 2014. framework and enable EAC partner
states NMRAs to provide services that
The overall objective of these QMS meet applicable statutory and regulatory
documents is to facilitate mutual recognition requirements.
and consistent regulatory services delivery
by Partner States NRMAs in the regulation of The EAC Code of Conduct for Partner
Medicines, Cosmetics, Medical Devices and States National Medicines Regulatory
Diagnostics in accordance with Chapter 21, Authorities aims at promoting public
Article 118 (c, d and e) of the EAC Treaty in confidence in activities of NMRA by ensuring
order to safeguard public health and improve highest level of integrity of the members of the
economic gains within the Community. governing boards, advisory committees and
iii
staff of EAC Partner States NMRAs through Special thanks go to the Bill and Melinda
disclosure of any circumstances that could Gates Foundation (BMGF), the World Bank,
give rise to a potential conflict of interest the New Partnership for Africa’s Development
related to their work. (NEPAD) for providing financial support.
The EAC QMS documents will be periodically I am grateful to the staff of EAC Secretariat,
reviewed to ensure their continued the EAC MRH project Steering Committee
consistency with any changes in the and EAC Partner States for their effective
applicable standards. coordination and implementation of this EAC
MRH project.
I would like to thank members of the
Technical Working Group (EWG) on Quality I also acknowledge the valuable contribution
Management System (QMS) for Regulations of the national and regional EAC stakeholders
of Medicines, Cosmetics , Medical who reviewed these EAC QMS documents
Devices and Diagnostics under the East and provided useful inputs.
African Community Medicines Regulatory
Harmonization (EAC-MRH) Project who
contributed to the successful development of
the first edition of these Quality Management
System (QMS) documents that include the
EAC Quality Management Requirements, the
EAC Guidelines for implementation of the
QMS requirements, the EAC Model Quality
Manual and the mandatory QMS procedures.
I would also like to thank the World Health
Organization (WHO) for providing technical
assistance towards the development of the
QMS documents.
Hon. Jesca Eriyo

Deputy Secretary General for
Productive and Social Sector
EAC Secretariat
iv
RESPONSIBILITY FOR IMPLEMENTATION AND

LEGAL FRAMEWORK
The EAC Sectoral Council Of Ministers of Health recognizes the work done by the EAC secretariat
in conjunction with EAC partner states NRMAs and supported by development partners in the
development of these QMS documents. These QMS documents will facilitate the implementation
of QMS in the EAC Partner States NMRAs.
The EAC Sectoral Council of Ministers of Health approves the use of these QMS documents in
the East African Community Partner States’ National Medicines Regulatory Authorities (NMRAs) in
accordance with Chapter 21, Article 118 (c, d,e and f) of the EAC Treaty. Implementation of these
documents will facilitate mutual recognition of regulatory decisions and attestation of the quality
and safety medicines, cosmetics, medical devices and diagnostics manufactured, produced,
imported, exported or traded in East African Community.
The EAC partner states Ministries responsible for Health shall be responsible for the
implementation of these QMS documents by their respective NMRAs.
SIGNED by the Hon. Ministers and Leaders of Delegation this 20th day of September, 2014.
........................ ........................ ........................ ........................ ........................
Amb. Amina Dr. Abdallah O. Hon. Léontine Hon. Valentine Hon. Shem
C. Mohamed, Kigoda Nzeyimana Rugwabiza Bageine, MP
CBS, CAV
Cabinet Minister Minister Minister for Minister of State

Secretary Ministry of Ministry to East African Ministry of
Ministry of Industry and the Office of Community East African
Foreign Affairs Trade the President Community
& International Responsible for Affairs
Trade EAC Affairs
REPUBLIC OF UNITED REPUBLIC OF REPUBLIC OF REPUBLIC OF

KENYA REPUBLIC OF BURUNDI RWANDA UGANDA
TANZANIA
v
AUTHORS/CONTRIBUTORS Inyangala Mwende Ronald; Director,

Business Support Services
Angole Apollo Pharmacy & Poisons BoardNairobi, Kenya
National Medicine Regulation Officer
National Drug Authority Kabatende Joseph
Kampala, Uganda Coordinator of Pharmaceutical Services
Ministry of Health
Chamngei Sichei Cheworei Kigali, Rwanda
Head, Policy and Planning Unit
Pharmacy and PoisonsBoard Khadija Ali Khamis
Nairobi, Kenya Quality Manager
Zanzibar Food and Drug Board
Daniel Murenzi Zanzibar, Tanzania
eHealth and Informatics Officer
EAC Secretariat Mashingia Jane
Arusha, Tanzania Senior Health Officer
(Medicines and Food Safety)
Didas Kamazima Mutabingwa EAC Secretariat, Arusha, Tanzania
Manager, Quality Management Tanzania Food
and Drugs Authority Mtalo A. Marcelina
Dar es Salaam, Tanzania Laboratory Quality Officer Tanzania Food and
DrugsAuthority, Dar es Salaam, Tanzania
Eunice Nakimuli
Drug Assessment and Registration Officer Mussa Abrahman Hamad
National Drug Authority Assistant Quality Manager
Kampala, Uganda Zanzibar Food and Drug Board
Zanzibar, Tanzania
Felista Chepwogen
National Medicine Regulation Officer Mwesigye John Patrick
Pharmacy and Poisons Board Nairobi, Kenya Senior Health Officer (Medicines Regulation)
EAC Secretariat, Arusha, Tanzania
Gideon Murimi
Head of ICT Ndayirorereye Marie Louise Head of Sales
Pharmacy and Poison Board Nairobi, Kenya Department Central d’Achat des Medicament
Essential, Bujumbura, Burundi
Gisagara Alex
National Medicine Regulation Officer Niyungeko Vanis
Pharmacy Task Force Procurement & Registration Officer
Kigali, Rwanda Ministry of Health/DPML
Bujumbura, Burundi
Hidaya Juma Hamad
National Medicine Regulation Officer Nyabenda Bonaventure
Zanzibar Food and Drugs Authority National Medicine Regulation Officer
Zanzibar, Tanzania Ministry of Health/DPML
Bujumbura, Burundi
vi
Nyawakira Anicet Burhani Othman Simai

Medicine Information Officer Ministry of Health Registrar
Kigali, Rwanda Zanzibar Food and Drugs Board
Zanzibar, Tanzania
Prat Alain
Technical Officer Joseph Kabatende
World Health OrganizationGeneva, Head of Inspectorate/Pharmacy
Switzerland Ministry of Health
Kigali, Rwanda
Ssali Peter
Head, Quality Management National Akimana Gladys
Drug Authority, Kampala, Uganda Pharmacovigilance Officer
Ministry of Health
EDITORIAL TEAM Kigali, Rwanda
Inyangala Mwende Ronald Habib Ali Shariff

Director, Business Support Services Chief Pharmacist
Pharmacy & Poisons Board Nairobi,Kenya Ministry of Health
Zanzibar, Tanzania
Nyawakira Anicet
Medicine Information Officer Ministry of Health William Reuben
Kigali, Rwanda Ag. Chief Pharmacist
Ministry of Health and social welfare
Ssali Peter Dar es Salaam, Tanzania
Head Quality Management National Drug
Authority Kampala, Uganda Gordon Katende Sematiko
Executive Secretary/Registrar,
EAC-MRH PROJECT STEERING National Drug Authority
COMMITTEE AND OTHER MEMBERS Kampala, Uganda
Kipkerich C. Koskei Oteba Olowo Martin

Registrar / Chief Pharmacist Assistant Commissioner, Pharmacy
Pharmacy and Poisons Board Ministry of Health
Nairobi, Kenya Kampala, Uganda
Fred Moin Siyoi Bamenyekanye Emmanuel

Deputy Registrar Director DPML/MOH
Pharmacy and Poisons Board Ministry of Health
Nairobi, Kenya Bujumbura, Burundi
Hiiti B. Sillo Dr. Ramana NV Gandham

Director General Lead Health Specialist
Tanzania Food and Drugs Authority (TFDA) The World Bank
Dar es Salaam, Tanzania Upper Hill Nairobi
vii
Dr. Andreas Seiter Hetzke Juorg

World Bank WHO Technical Advisor
1818H Street NW, G7-701 World Health Organization
Washington DC 20043 Switzerland
Avenue Appia20, 1211
Apollo. Edson Muhairwe Geneva, Switzerland
Senior Operations Officer
World Bank Prof. Aggrey Ambali
P.O. Box 4463, Advisor and Head
Kampala, Uganda NEPAD Agency, South Africa
Dr.Vincent Ahonkhai Margareth Ndomondo Sigonda

Bill and Melinda Gates Foundation, USA Pharmaceutical Coordinator
AU – NEPAD Agency
Dr. Stanley Sonoiya Midrand, South Africa
Principal Health Officer (PHO) South Africa
EAC Secretariat
P.O. Box 1096, Arusha-Tanzania Mrs. Chimwemwe Chamdimba
Senior Program Officer
Dr. Kamamia Wa Murichu NEPAD Agency.
Chairman Kenya Pharmaceutical Distributors
Association Mr. Paul K. Tanui
P.O. Box 1088-10200, Nairobi, Kenya Senior Program Officer
NEPAD Agency.
Mendy Caroline P. O BOX 1627
Manager Regulatory, IFPMA South Africa.
Chemin Lovis Dunant 15
1202 Geneva Switzerland Janet Okero
Senior Programme Officer
Dr. Samuel Azatyan AU – NEPAD Agency
Programme Manager, Medicines Private Bag 218, Halfway Hse
Regulatory Support Midrand, 1685, South Africa
World Health Organization
Switzerland
Avenue Appia 20, 1211, Switzerland
viii
TABLE OF CONTENTS
DOCUMENTS DEVELOPMENT HISTORY i

FOREWARD ii
PREFACE iii
RESPONSIBILITY FOR IMPLEMENTATION AND LEGAL FRAMEWORK v
AUTHORS vi
EDITORIAL TEAM vii
Table of Content ix
PART ONE: EAC QUALITY MANAMEGENT REQUIREMENTS 1
0. INTRODUCTION 2
0.1. Background 2
0.2. Objectives 2
0.3. Scope of EAC QMS requirements document 2
QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS 3

1. Scope 3
1.1. General 3
1.2. Application 3
2. Normative references 3
3. Terms and definitions 4
4. Quality management system 4

4.1. General requirements 5
4.2. Documentation requirements 5
4.2.1. General 5
4.2.2. Quality manual 5
4.2.3. Control of documents 5
4.2.4. Control of records 6
5. Management responsibilities 6
5.1. Management commitment 6
5.2. Customer focus 6
5.3. Quality policy 7
5.4. Planning 7
5.4.1. Quality objectives 7
5.4.2. Quality management system planning 7
5.5 Responsibility, authority and communication 7
5.5.1 Responsibility and authority 7
5.5.2 Management representative 7
5.5.3 Internal communication 8

ix
5.6. Management review 8

5.6.1. General 8
5.6.2. Review input 8
5.6.3. Review output 8
6. Resource management 9
6.1. Provision of resources 9
6.2. Human resources 9
6.2.1 General 9
6.2.2. Competence, training and awareness 9
6.2.3. Impartiality and independence 9
6.2.4. Confidentiality 10
6.3. Infrastructure 10
6.4. Work environment 10
7. Service realizations 11
7.1 Planning of service realization 11
7.2 Customer-related processes 11
7.2.1. Determination of requirements related to the service 11
7.2.3. Review of requirements related to the service 11
7.2.3. Customer communication 12
7.2.4. Complaints and appeals 12
7.2.5. Complaints and appeals process 12
7.3. Design and development 13
7.3.1. Design and development planning 13
7.3.2. Design and development inputs 13
7.3.3. Design and development outputs 13
7.3.4. Design and development review 14
7.3.5. Design and development verification 14
7.3.6. Design and development validation 14
7.3.7.Control of design and development changes 14
7.4 Purchasing 14
7.4.1 Purchasing process 14
7.4.2 Purchasing information 14
7.4.3 Verification of purchased product 15
7.5. Service provision 15
7.5.1 Control of service provision 15
7.5.2 Validation of processes for service provision 15
7.5.3 Identification and traceability 16
7.5.4 Customer property 16
7.5.5 Preservation of product 16
7.6 Control of monitoring and measuring equipment 16
8. Measurement, analysis and improvement 17

8.1. General 17
x
8.2. Monitoring and measurement 17

8.2.1. Customer satisfaction 17
8.2.2. Internal audit 17
8.2.3. Monitoring and measurement of processes 18
8.2.4. Monitoring and measurement of service 18
8.3. Control of nonconforming product 18
8.4. Analysis of data 19
8.5. Improvement 19
8.5.1. Continual improvement 19
8.5.2. Corrective action 19
8.5.3. Preventive action 20
REFERENCES 20
REVISION HISTORY
PART TWO: EAC GUIDELINES FOR IMPLEMTATION OF QMS 22

REQUIRMENTS
0. INTRODUCTION 22
0.1. Background 22
0.2. Objectives 22
0.3. Scope of EAC Guidelines for implementing QMS requirements 22
QUALITY MANAGEMENT SYSTEM 23
1. General 23
1.1. Scope 23
2. Normative references 23
3. Terms and definitions 23
4. Quality Management System 24

4.2. Documentation requirements 24
4.2.1 General 24
4.2.2 Quality Management 26
4.2.3 Control of documents 27
4.2.4 Control of records 28
5. Management responsibility 29
5.1 Management commitment 30
5.2 Customer focus 30
5.3 Quality policy 31
5.4 Planning 31
5.4.1 Quality objectives 31
xi
5.4.2 Quality management system planning 32

5.5.2 Management Representative 33
5.6 Management review 34
5.6.1 General 34
5.6.2 Review input 34
5.6.3 Review output 35
6.0 Resource management 35

6.1 Provision of resources 35
6.2 Human Resources 36
6.2.1 General 36
6.2.2 Competence, awareness and training 36
6.2.3 Impartiality and independence 37
6.2.4 Confidentiality 37
6.3 Infrastructure 38
6.4 Work environment 38
7.0 Product realization 38

7.1 Planning of services realization 39
7.2 Customer related process 39
7.2.1 Determination of requirements related to the service 39
7.2.2 Review of requirements related to the services 39
7.2.3 Customer communication 40
7.2.4 Complaints and appeals 40
7.2.5 Complaints and appeals process 41
7.3 Design and Development 42
7.3.1 Design and development planning 42
7.3.2 Design and development inputs 42
7.3.3 Design and development outputs 43
7.3.4 Design and development review 44
7.3.5 Design and development verification 44
7.3.6 Design and development validation 44
7.3.7 Control of design and development changes 44
7.4 Purchasing 44
7.4.2 Purchase Information 46
7.5 Production and service provision 47
7.5.1 Control of production and service provision 47
7.5.2 Validation of processes for production and service provision 47
xii
7.5.5 Preservation of product 49

7.6 Control of monitoring and measuring equipment 49
8.0 Measurement, analysis and improvement 51
8.1 General 51
8.2 Monitoring and measurement 51
8.2.1 Customer Satisfaction 51
8.2.2 Internal audit 51
8.2.3 Monitoring and measurement of processes 52
8.2.4 Monitoring and measurement of product 53
8.3 Control of nonconforming product 53
8.4 Analysis of data 54
8.5 Improvement 55
8.5.1 Continual improvement 55
8.5.2 Corrective action 55
8.5.3 Preventive action 57
BIBLIOGRAPHY 57
REVISION HISTORY 57
PART THREE: Model Manual on the Implementation of the EAC QMS 58

Requirements for NMRA
0. INTRODUCTION 59
0.1 Background 59
0.2. Objectives 59
0.3. Scope of EAC QMS model manual
QUALITY MANAGEMENT SYSTEM 60
1. SCOPE 60
1.1. General 60
1.2. Application of the Quality Management System 60
1.3. Exclusions from the EAC QMS requirements 60
2. NORMATIVE REFERENCES 60
3. TERMS AND DEFINITIONS 60
4. QUALITY MANAGEMENT SYSTEM 61

4.2. Document requirement 62
4.2.1 General 62
4.2.2 Quality Manual 62
4.2.3 Control of documents 62
4.2.4 Control of records 62
xiii
5. Management responsibilities 62
5.1 Management commitment 62
5.2 Customer focus 62
5.3 Quality policy 63
5.4 Planning 63
5.4.1 Quality objectives 63
5.4.2 Quality management system planning 63
5.5.2 Management representative 63
5.6 Management review 64
5.6.1 General 64
5.6.2 Review input 64
5.6.3 Review output 65
6. Resource management 65
6.1 Provision of resources 65
6.2 Human resources 65
6.2.1 General 65
6.2.2 Competence, training and awareness 65
6.2.3 Impartiality and independence 65
6.2.4 Confidentiality 66
6.3 Infrastructure 66
6.4 Work environment 66
7.0 Product realization 66

7.1 Planning of product realization 66
7.2 Customer related processes 66
7.2.1 Determination of requirements related to the product 66
7.2.2 Review of requirements related to the product 67
7.2.3 Customer communication 67
7.2.4 Complaints and appeals 67
7.2.5 Complaints and appeal process 67
7.3 Design and Development 67
7.3.1 Design and Development Planning 67
7.3.2 Design and Development Inputs 67
7.3.3 Design and Development Outputs 67
7.3.4 Design and Development Review 67
7.3.5 Design and Development Verification 68
7.3.6 Design and Development Validation 68
7.3.7 Control of Design and Development Changes 68

xiv
7.4 Purchasing 68
7.4.2 Purchasing information 68
7.5 Production and service provision 69
7.5.1 Control of production and service provision 69
7.5.2 Validation of processes for production and service provision 69
7.5.5 Preservation of the product 69
7.6. Control of monitoring and measuring equipment 70
8.0 Measurement, analysis and improvement 70

8.1 General 70
8.2 Monitoring and measurement 70
8.2.1 Customer satisfaction 70
8.2.2 Internal audit 70
8.2.3 Monitoring and measurement of processes 71
8.2.4 Monitoring and measurement of services 72
8.3 Control of non-conforming product 72
8.4 Analysis of data 72
8.5 Improvement 73
8.5.1 Continual improvement 73
8.5.2 Corrective action 73
8.5.3 Preventive action 74
REVISION HISTORY 74
Annex 1- Model Process interaction diagram: 75
Annex 2: Model Quality Policy. 77
Annex 3 Medicine Regulations mapping processes 78
PART FOUR: EAC QMS Model Standard Procedures 86
0. INTRODUCTION 87
EAC Model Procedure for Control of Documents 87
EAC Model Procedure for Control of Records 102
EAC Model procedure for Conducting Internal Quality Audit, 107
EAC Model procedure for Control of Non-Conforming Product 118
Doc. # EAC/TF-MED/QMS/FD/SOP 118
EAC Model procedure for Handling Customer Complaints and Appeals 123
EAC Model procedure for handling Corrective and Preventive Action 128
Model standard operating procedure: 134
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PART FIVE: Code of Conduct for EAC Partner States NMRA 137
0. INTRODUCTION 138
0.1 Background 138
0.2. Objectives 138
0.4. Legal basis 138
1. CODE OF CONDUCT 138
2. GUIDANCE ON CONFLICTS OF INTERESTS 140

2. 1. Meaning of “conflict of interest” 140
2. 2. Types of Interests 140
2.2.1. Direct Interest 140
2.2.2. Interests of Others 140
2.3. When is the NMRA personnel required to complete a declaration of 141
interests form?
2.4. Examples of interests that must be disclosed 152 141
2.5. How to analyse the information disclosed? 142
2.6. Safety of the filled DOI forms 142
3. GUIDANCE ON CONFIDENTIALITY 143

3.1. Introduction 143
3.2 Confidential Information 143
3.3 Duty of confidentiality 143
3.4. Continuing duty of confidentiality 144
3.5. When is the NMRA personnel required to complete a confidentiality 145
undertaking form?
ANNEX 1: DECLARATION OF INTERESTS 146
XVI
XVII
PART ONE
EAC QUALITY MANAMEGENT’S REQUIREMENTS
01
0. INTRODUCTION 0.2. Objectives
0.1. Background The overall objective of this document is

to ensure that adequate quality standards
One of the goals of East African Community are maintained in each of the EAC Partner
(EAC) Medicines Regulatory Harmonization State NMRAs so as to achieve consistency
Project is to have harmonized and functioning in regulatory service delivery and facilitate
Quality Management System (QMS) within mutual confidence and recognition.
the EAC National Medicines Regulatory
Authorities (NMRAs) in accordance with The specific objectives of this document
national and internationally recognized are to:
standards. This document provides
requirements for implementing quality a) enable the establishment,
management systems in NMRAs of the EAC. and maintenance of the EAC QMS
all EAC partner states NMRAs;
All NMRAs in the EAC have management
systems for creating and delivering their b) enable EAC partner states to
services to customers. However, some of the adopt a common standard
NMRAs lack quality management systems quality system requirements in order
which would lead to wasteful processes, poor achieve consistency in services
services delivery and dissatisfied customers. in the EAC NMRAs; and
This document outlines the quality system c) facilitate mutual recognition and
requirements for our NMRA QMS. It is confidence amongst EAC NMRAs.
intended that each NMRA uses the document
as the basis for developing and implementing 0.3. Scope of EAC QMS
its own QMS and for preparing its own quality requirements document
manual. In addition to providing a basis for
self-assessment and a reference document for This document specifies QMS requirements
use by external assessors, establishing and for EAC NMRAs in the regulation of
maintaining an effective QMS will generate medicines, cosmetics, medical devices and
confidence within and between EAC NMRAs diagnostics.
in the assessment of QMS compliance.
EAC NMRAs should co-operate with one

another in exchanging experiences in the
maintenance and operation of quality systems
and in the further development of this
document.
02
QUALITY MANAGEMENT a) ISO/IEC 17025: 2005 – General

requirements for the competence of
SYSTEMS - REQUIREMENTS testing and calibration laboratories
1. Scope b) ISO/IEC 17020: 2012 Conformity

assessment - Requirements
1.1. General for the operation of various types of
bodies performing inspection
This document specifies requirements for a
quality management system where an EAC c) PI 002_3: 2007 PIC/S -
Partner State NMRA: Recommendations on Quality
system requirements for
a) needs to demonstrate its ability pharmaceutical inspectorates
to consistently provide product that
meets customer and applicable Where any requirement(s) of these EAC QMS
and regulatory requirements. requirements cannot be applied due to the
nature of an NMRA and its product, this can
b) aims to enhance customer be considered for exclusion.
satisfaction through the effective
application of the system, including Where exclusions are made, claims of
processes or continual improvement conformity to this International Standard are
of the system and the assurance not acceptable unless these exclusions are
of conformity to customer and limited to requirements within Clause 7, and
applicable laws, statutory and such exclusions do not affect the NMRA’s
regulatory requirements. ability, or responsibility, to provide product that
meets customer and applicable statutory and
NOTE: regulatory requirements.
Statutory and legal requirements include
national (e.g. national health policy, NMRA 2. Normative references
Acts, etc); regional (EAC policies on medicine
regulation) and international (WHO guidelines, This document has been developed according
etc) obligations to ISO 9001:2008 - “Quality Management
Systems requirements”. In addition,
1.2. Application the following referenced documents are
indispensable for the application of the QMS:
1.2.1 The requirements of this document
apply to all directorates, a) ISO 9000:2005, Quality
departments, units and sections of Systems - Fundamentals
the EAC Partner States NMRAs. and Vocabulary.
NMRAs may also be required to
comply with the following ISO b) ISO/IEC 17025: 2005 - General
standards and PIC/S guidelines: requirements for the competence of
testing and calibration laboratories
03
c) ISO/IEC 17020: 2012 Conformity NOTE 3

assessment - Requirements “Unregulated Customer”: Organisation or
for the operation of various types of person who is not subject to regulation
bodies performing inspection by NMRAs.
d) PI 002_3: 2007 PIC/S - b) “Product” : Applies to regulatory

Recommendations on Quality services intended for, or required by,
system requirements for the customer (regulated
pharmaceutical inspectorates EAC and/or unregulated customer) and
Partner states application statutory to any intended output resulting
and legal requirements from the product realization
processes of the NMRA
e) EAC Standards, Quality, Metrology (e.g. market authorization
and Testing (SQMT) Act or medicine registration certificates,
(2006) - revised 2013 licences, permits, good
manufacturing practice certificates,
f) Any other recognised standard good distribution practice
or laws that may be published in the certificates, medicine/drug register)
EAC Gazette
c) “Top management” person or
3. Terms and definitions group of people who directs and
controls an NMRA at the highest
For the purposes of this document, the terms level.
and definitions given in ISO 9000: 2005 apply.
For the NMRAs, the following terms and 4. Quality management system
definitions for “product”, “customer” and “Top
Management” shall apply: 4.1. General requirements
a) Customer: organization or The NMRA shall establish, document,

person that receives a product. implement and maintain a quality
EXAMPLE Consumer, client, end- management system and continually improve
user, retailer, beneficiary and its effectiveness in accordance with the EAC
purchaser. QMS requirements in this document.
NOTE 1 To design and implement the QMS the

A customer can be internal or external to the NMRA shall:
organization.
a) determine the processes needed
NOTE 2 for the quality management system
“Regulated Customer”: Organisation or person and their application
who by the nature of their business are subject throughout the NMRA (see 1.2),
to regulation by the NMRAs
b) determine the sequence and
interaction of these processes,
04
c) determine criteria and methods d) documents, including records,

needed to ensure that both the determined by the NMRA to be
operation and control of these necessary to ensure the
processes are effective, effective planning, operation and
control of its processes.
d) ensure the availability of resources
and information necessary to NOTE:
support the operation and Where the term “documented procedure”
monitoring of these processes, appears within this EAC QMS Requirement,
this means that the procedure is established,
e) monitor, measure where applicable, documented, implemented and maintained. A
and analyse these processes, and single document may address the requirement
for one or more procedures. A requirement for
f) implement actions necessary a documented procedure may be covered by
to achieve planned results and more than one document.
continual improvement of these
processes. 4.2.2 Quality manual
These processes shall be managed by the The NMRA shall establish and maintain a
NMRA in accordance with the requirements of quality manual that includes:
this EAC QMS Requirements.
a) the scope of the quality
Where an NMRA chooses to outsource any management system the
process that affects product conformity to documented procedures
requirements, the NMRA shall ensure control established for the quality
over such processes. The type and extent management system,
of control to be applied to these outsourced or reference to them,
processes shall be defined within the quality
management system. b) a description of the interaction
between the processes of the
4.2. Documentation requirements quality management system
4.2.1. General 4.2.3. Control of documents
The quality management system Documents required by the quality

documentation shall include: management system shall be controlled.
Records are a special type of document
a) documented statements of a quality and shall be controlled according to the
policy and quality objectives, requirements given in 4.2.4.
b) a quality manual, A documented procedure shall be established

to define the controls needed
c) documented procedures and
records required by EAC QMS a) to approve documents for adequacy
requirement prior to issue,
05
b) to review and update as necessary 5. Management responsibilities

and re-approve documents,
Top management shall develop the strategic
c) to ensure that changes and the plan, business plan, mission, vision,
current revision status of documents core values for the whole NMRA. QMS
are identified, requirements shall be clearly identified in the
strategic plan and business plan of the NMRA
d) to ensure that relevant versions of
applicable documents are available 5.1. Management commitment
at points of use,
Top management shall provide evidence
e) to ensure that documents remain of its commitment to the development and
legible and readily identifiable, implementation of the quality management
system and continually improving its
f) to ensure that documents of effectiveness by:
external origin determined by the
organization to be necessary for t a) communicating to the NMRA the
he planning and operation of the importance of meeting customer as
quality management system are well as statutory and regulatory
identified and their distribution requirements,
controlled, and
b) establishing the quality policy,
g) to prevent the unintended use of
obsolete documents, c) ensuring that quality objectives are
and to apply suitable identification established,
to them if they are retained for any
purpose. d) conducting management
reviews, and
4.2.4. Control of records
e) ensuring the availability
The NMRA shall determine and control the of resources.
records established to provide evidence of
conformity to requirements and of the effective 5.2. Customer focus
operation of the quality management system.
The NMRA shall establish a documented Top management shall ensure that customer
procedure to define the controls needed for requirements are determined and are met with
the identification, storage, protection, retrieval, the aim of enhancing customer satisfaction
retention and disposition of records. A list (see 7.2.1 and 8.2.1).
of the controlled records and their required
retention periods shall be established and
maintained.
Records shall remain legible, readily

identifiable and retrievable.
06
5.3. Quality policy b) the integrity of the quality

management system is maintained
Top management shall ensure that the quality when changes to the quality
policy management system are planned
and implemented.
a) is appropriate to the purpose of the
NMRA, c) in planning for the QMS, top
management shall ensure that a
b) includes a commitment to comply strategic plan is developed.
with requirements and continually
improve the effectiveness of the 5.5 Responsibility, authority
quality management system, and communication
c) provides a framework for 5.5.1 Responsibility and authority

establishing and reviewing quality
objectives, Top management shall ensure that
responsibilities and authorities are defined
d) is communicated and understood and communicated within the NMRA.
within the NMRA, and
a) The NMRA shall establish an
e) is reviewed for continuing suitability. organizational chart that clearly
shows the inter-relationship and
5.4. Planning reporting mechanism of the
personnel in the NMRA.
5.4.1. Quality objectives
b) The NMRA shall establish job
Top management shall ensure that quality descriptions defining the
objectives, including those needed to meet responsibilities and authorities
requirements for product [see 7.1 a)], are of each of the employee positions
established at relevant functions and levels on the organizational structure.
within the NMRA. The quality objectives shall
be measurable and consistent with the quality Management representative
policy.
Top management shall appoint a member of
5.4.2. Quality management system the NMRA’s management who, irrespective of
planning other responsibilities, shall have responsibility
and authority that includes:
Top management shall ensure that:
a) ensuring that processes needed
a) the planning of the quality for the quality management system
management system is carried out are established, implemented and
in order to meet the requirements maintained,
given in 4.1 as well as the quality
objectives, and
07
b) reporting to top management on 5.6.2. Review input

the performance of the quality
management system and any need The input to management review shall include
for improvement, and information on:
c) ensuring the promotion of a) results of audits,

awareness of customer
requirements throughout the b) customer feedback,
organization.
c) process performance and product
NOTE: conformity,
The responsibility of a management
representative can include liaison with external d) status of preventive and corrective
parties on matters relating to the quality actions,
management system. e)
follow-up actions from previous
5.5.3 Internal communication management reviews,
Top management shall ensure that appropriate f) changes that could affect the quality
communication processes are established management system, and
within the NMRA and that communication
takes place regarding the effectiveness of the g) recommendations for improvement.
quality management system.
5.6.3. Review output
5.6. Management review
The output from the management review shall
5.6.1. General include any decisions and actions related to:
Top management shall review the NMRA’s a) improvement of the effectiveness

quality management system, at planned of the quality management system
intervals, at least once a year, to ensure and its processes,
its continuing suitability, adequacy and
effectiveness. This review shall include b) improvement of product related to
assessing opportunities for improvement customer requirements, and
and the need for changes to the quality
management system, including the quality c) resource needs.
policy and quality objectives.
Records from management reviews shall be

maintained (see 4.2.4).
08
6. Resource management c) evaluate the effectiveness of the

actions taken,
6.1 Provision of resources
d) ensure that its personnel are
The NMRA shall determine and provide the aware of the relevance and
resources needed importance of their activities and
how they contribute to the
a) to implement and maintain the achievement of the quality
quality management system and objectives, and
continually improve its effectiveness,
and e) maintain appropriate records of
education, training, skills and
experience (see 4.2.4)
b) to enhance customer satisfaction by
ZZ meeting customer requirements. f) develop a code of conduct in
accordance with national public
6.2. Human resources service code of conduct
6.2.1 General
6.2.3. Impartiality and independence
Personnel performing work affecting
conformity to product requirements shall a) The NMRA shall be responsible for
be competent on the basis of appropriate the impartiality of its activities and
education, training, skills and experience. shall not allow commercial, financial
or other pressures to compromise
NOTE: impartiality.
Conformity to service requirements can be
affected directly or indirectly by personnel b) The NMRA shall identify risks to
performing any task within the quality its impartiality on an ongoing basis.
management system. This shall include those risks
that arise from its activities, or from
6.2.2. Competence, training its relationships, or from the
and awareness relationships of its personnel.
However, such relationships do not
The NMRA shall: necessarily present an NMRA with a
risk to impartiality.
a) determine the necessary
competence for personnel c) If a risk to impartiality is identified,
performing work affecting conformity the NMRA shall be able to
to product requirements, demonstrate how it eliminates or
minimizes such risk.
b) where applicable, provide training
or take other actions to achieve the d) The NMR shall have top
necessary competence, management commitment to
impartiality.
9
e) The NMRA shall be independent to c) Information about the client obtained

the extent that is required with from sources other than the client
regard to the conditions under which (e.g. complainant, regulators) shall
it performs its services. be treated as confidential.
f) The NMRA shall establish a d) The NMRA shall establish

documented procedure to manage a documented procedure to manage
impartiality and independence confidentiality
6.2.4. Confidentiality 6.3. Infrastructure
a) The NMRA shall be responsible, The NMRA shall determine, provide and
through legally enforceable maintain the infrastructure needed to
commitments, for the management achieve conformity to product requirements.
of all information obtained or Infrastructure includes, as applicable,
created during the performance
of its regulatory activities. The a) buildings, workspace and
NMRA shall inform the client, in associated utilities,
advance, of the information
it intends to place in the public b) process equipment (both hardware
domain. Except for information and software), and
that the client makes publicly
available, or when agreed c) supporting services (such as
between the NMRA and the transport, communication or
client (e.g. for the purpose information systems).
of responding to complaints), all
other information is considered 6.4. Work environment
proprietary information and shall be
regarded as confidential. The NMRA shall determine and manage
the work environment needed to achieve
NOTE: conformity to product requirements.
Legally enforceable commitments can be, for
example, contractual agreements. NOTE:
The term “work environment” relates to those
b) When the NMRA is required by law conditions under which work is performed
or authorized by contractual including physical, environmental and other
commitments to release confidential factors (such as noise, temperature, humidity,
information, the client or individual lighting or weather).
concerned shall, unless prohibited
by law, be notified of the information
provided.
10
7. Service realizations requirements for delivery and post-

delivery activities,
7.1 Planning of service realization
b) requirements not stated by the
The NMRA shall plan and develop the customer but necessary for
processes needed for service realization. specified or intended use, where
Planning of service realization shall be known,
consistent with the requirements of the other
processes of the quality management system c) statutory and regulatory
(see 4.1 as appropriate). requirements applicable to the
service, and
In planning servicerealization, the NMRA shall
determine the following, as appropriate: d) any additional requirements
considered necessary by the
a) quality objectives and requirements NMRA.
for the service;
7.2.2. Review of requirements related
b) the need to establish processes and to the service
documents, and to provide
resources specific to the service The NMRA shall review the requirements
related to the service this review shall be
c) required verification, validation, conducted prior to the NMRA’s commitment
monitoring, measurement, to provide a service to the customer (e.g.
inspection and test activities Licensing, Product registration and market
specific to the service and the authorization, certification, GMP inspection
criteria for serviceacceptance; and others) and shall ensure that
d) records needed to provide evidence a) service requirements are defined,

that the realization processes and
resulting service meet requirements b) service requirements differing from
(see 4.2.4 as appropriate) those previously expressed are
The output of this planning shall be resolved, and
in a form suitable for the NMRA’s
method of operations. c) the NMRA has the ability to meet
the defined or new requirements.
7.2 Customer-related processes
Records of the results of the review and
7.2.1. Determination of requirements actions arising from the review shall be
related to the service maintained (see 4.2.4).
The NMRA shall determine: Where the customer provides no documented

statement of requirement, the customer
a) requirements specified by the requirements shall be confirmed by the NMRA
customer, including the before acceptance.
11
Where service requirements are changed, the 7.2.5. Complaints and appeals process
NMRA shall ensure the relevant documents
are amended and that relevant personnel are 7.2.4.6 The handling process for complaints
made aware of the changed requirements. and appeals shall include at least
the following elements and
7.2.3. Customer communication methods:
The NMRA shall determine and implement a) a description of the process for
effective arrangements for communicating with receiving,
customers in relation to:
b) validating,
a) service information,
c) investigating the complaint or
b) enquiries, new service information appeal, and deciding what actions
including amendments, and are to be taken in response to it;
c) customer feedback, including d) tracking and recording complaints

customer complaints and appeals, including actions
undertaken to resolve them;
7.2.4. Complaints and appeals e) ensuring that any appropriate action
is taken.
7.2.4.1 The NMRA shall have a
documented procedure to receive, 7.2.4.7 The NMRA shall be responsible
evaluate and make decisions on for gathering and verifying all
complaints and appeals. necessary information to validate
the complaint or appeal.
7.2.4.2 A description of the handling
process for complaints and appeals 7.2.4.8 Whenever possible, the NMRA
shall be available to any interested shall acknowledge receipt of the
party upon request. complaint or appeal, and shall
provide the complainant or appellant
7.2.4.3 Upon receipt of a complaint, the with progress reports and
NMRA shall confirm whether the the outcome.
complaint relates to its activities for
which it is responsible and, if so, 7.2.4.9 The decision to be communicated to
shall deal with it. the complainant or appellant shall
be made by, or reviewed and
7.2.4.4 The NMRA shall be responsible approved by, individual(s) not
for all decisions at all levels of the involved in the original activities
handling process for complaints in question.
and appeals.
7.2.4.5 Investigation and decision on

appeals shall not result in any
discriminatory actions.
12
7.2.4.10 Whenever possible, the NMRA 7.3.2. Design and development inputs
shall give formal notice of the end of
the complaint and appeals handling Inputs relating to service requirements shall
process to the complainant be determined and records maintained (see
or appellant. 4.2.4).
7.3. Design and development These inputs shall include:
7.3.1. Design and development a) functional and performance

planning requirements,
The NMRA shall plan and control the design b) applicable statutory and regulatory
and development of service. requirements,
During the design and development planning, c) where applicable, information

the NMRA shall determine: derived from previous similar
designs, and
a) the design and development stages,
d) other requirements essential for
b) the review, verification and design and development.
validation that are appropriate to
each design and development The inputs shall be reviewed for adequacy.
stage, and Requirements shall be complete,
unambiguous and not in conflict with each
c) the responsibilities and authorities other.
for design and development.
7.3.3. Design and development outputs
The NMRA shall manage the interfaces
between different groups involved in design The outputs of design and development shall
and development to ensure effective be in a form suitable for verification against
communication and clear assignment of the design and development input and shall
responsibility. be approved prior to release.
Planning output shall be updated, as Design and development outputs shall:

appropriate, as the design and development
progresses. a) Meet the input requirements for
design and development,
NOTE:
Design and development review, verification b) provide appropriate information for
and validation have distinct purposes. They purchasing, production and service
can be conducted and recorded separately or provision,
in any combination, as suitable for the service
and the NMRA. c) contain or reference product
acceptance criteria, and;
13
d) specify the characteristics of the 7.3.6. Design and development

product that are essential for its safe validation
and proper use.
Design and development validation shall
NOTE: be performed in accordance with planned
Information for production and service arrangements (see 7.3.1) to ensure that the
provision can include details for the resulting product is capable of meeting the
preservation of product. requirements for the specified application
or intended use, where known. Wherever
7.3.4. Design and development review practicable, validation shall be completed
prior to the delivery or implementation
At suitable stages, systematic reviews of of the product. Records of the results of
design and development shall be performed in validation and any necessary actions shall be
accordance with planned arrangements (see maintained (see 4.2.4).
7.3.1)
7.3.7. Control of design and
a) to evaluate the ability of the development changes
results of design and development
to meet requirements, and Design and development changes shall
be identified and records maintained. The
b) to identify any problems and changes shall be reviewed, verified and
propose necessary actions. validated, as appropriate, and approved
before implementation. The review of design
Participants in such reviews shall include and development changes shall include
representatives of functions concerned with evaluation of the effect of the changes
the design and development stage(s) being on constituent parts and service already
reviewed. Records of the results of the delivered. Records of the results of the review
reviews and any necessary actions shall be of changes and any necessary actions shall
maintained (see 4.2.4). be maintained (see 4.2.4).
7.3.5. Design and development 7.4 Purchasing

verification
7.4.1 Purchasing process
Verification shall be performed in accordance
with planned arrangements (see 7.3.1) to The NMRA shall ensure that purchased
ensure that the design and development product conforms to specified purchase
outputs have met the design and development requirements. The type and extent of control
input requirements. applied to the supplier and the purchased
product shall be dependent upon the effect of
Records of the results of the verification and the purchased product on subsequent service
any necessary actions shall be maintained realization or the final service.
(see 4.2.4).
The NMRA shall evaluate and select
suppliers based on their ability to supply
product in accordance with the organization’s
14
requirements. Criteria for selection, evaluation 7.5. Service provision

and re-evaluation shall be established.
7.5.1 Control of service provision
Procurements in most NMRs are regulated
by national laws. The NMRA shall therefore The NMRA shall plan and carry out service
comply with such applicable national legal provision under controlled conditions.
procurement requirements. Controlled conditions shall include, as
applicable,
Records of the results of evaluations and any
necessary actions arising from the evaluation a) the availability of information that
shall be maintained (see 4.2.4). describes the characteristics of the
service,
7.4.2 Purchasing information
b) the availability of work instructions,
Purchasing information shall describe the as necessary,
product to be purchased, including, where
appropriate, c) the use of suitable equipment,
a) requirements for approval d) the availability and use of

of product, procedures, processes monitoring and measuring
and equipment, equipment,
b) requirements for qualification of e) the implementation of monitoring

personnel, and and measurement, and

c) quality management system f) the implementation of
requirements. service delivery activities.
The NMRA shall ensure the adequacy of 7.5.2 Validation of processes for
specified purchase requirements prior to their service provision
communication to the supplier.
The NMRA shall validate any processes for
7.4.3 Verification of purchased product service provision where the resulting output
cannot be verified by subsequent monitoring
The NMRA shall establish and implement or measurement and, as a consequence,
the inspection or other activities necessary deficiencies become apparent only after the
for ensuring that purchased product meets the service has been delivered.
specified purchase requirements.
Validation shall demonstrate the ability of
Where the NMRA or its customer intends to these processes to achieve planned results.
perform verification at the supplier’s premises, The NMRA shall establish arrangements for
the organization shall state the intended these processes including, as applicable,
verification arrangements and method of
product release in the purchasing information
15
a) defined criteria for review and 7.5.5 Preservation of product

approval of the processes,
The NMRA shall preserve the product
b) approval of equipment and during internal processing and delivery to
qualification of personnel, the intended destination in order to maintain
conformity to requirements. As applicable,
c) use of specific methods and preservation shall include identification,
procedures, handling, packaging, storage and protection.
d) requirements for records (see Preservation shall also apply to the constituent
4.2.4), and parts of a product.
e) revalidation. 7.6 Control of monitoring and

measuring equipment
7.5.3 Identification and traceability
NMRAs shall determine the monitoring and
Where appropriate, the NMRA shall identify measurement to be undertaken and the
the product by suitable means throughout monitoring and measuring equipment needed
product realization. to provide evidence of conformity of product to
determined requirements.
The organization shall identify the product
status with respect to monitoring and The NMRA shall establish processes to
measurement requirements throughout ensure that monitoring and measurement can
product realization. be carried out and are carried out in a manner
that is consistent with the monitoring and
Where traceability is a requirement, the NMRA measurement requirements.
shall control the unique identification of the
product and maintain records (see 4.2.4). Where necessary to ensure valid results,
measuring equipment shall:
7.5.4 Customer property
a) be calibrated or verified, or
The NMRA shall exercise care with customer both, at specified intervals,
property while it is under the NMRAs control or prior to use, against
or being used by the NMRA. The NMRA shall measurement standards
identify, verify, protect and safeguard customer traceable to international or national
property provided for use or incorporation into measurement standards; where
the product. If any customer property is lost, no such standards exist, the basis
damaged or otherwise found to be unsuitable used for calibration or verification
for use, the NMRA shall report this to the shall be recorded (see 4.2.4);
customer and maintain records (see 4.2.4).
b) be adjusted or re-adjusted as
necessary;
c) have identification in order to

determine its calibration status;
16
d) be safeguarded from adjustments b) to ensure conformity of the quality

that would invalidate the management system, and
measurement result;
c) to continually improve the
e) be protected from damage and effectiveness of the quality
deterioration during handling, management system.
maintenance and storage.
This shall include determination of applicable
In addition, the NMRA shall assess and record methods, including statistical techniques, and
the validity of the previous measuring results the extent of their use.
when the equipment is found not to conform
to requirements. The NMRA shall take 8.2. Monitoring and measurement
appropriate action on the equipment and any
product affected. 8.2.1. Customer satisfaction
Records of the results of calibration and As one of the measurements of the

verification shall be maintained (see 4.2.4). performance of the quality management
When used in the monitoring and system, the NMRA shall monitor information
measurement of specified requirements, the relating to customer perception as to whether
ability of computer software to satisfy the the NMRA has met customer requirements.
intended application shall be confirmed. This
shall be undertaken prior to initial use and The methods for obtaining and using this
reconfirmed as necessary. information shall be determined.
NOTE: 8.2.2. Internal audit

Confirmation of the ability of computer
software to satisfy the intended application The NMRA shall conduct internal audits at
would typically include its verification and planned intervals but at least once every year
configuration management to maintain its to determine whether the quality management
suitability for use. system
8. Measurement, analysis a) conforms to the planned

and improvement arrangements (see 7.1), to
the EAC QMS requirements and to
8.1 General the quality management system
requirements established by the
The NMRA shall plan and implement the NMRA, and
monitoring, measurement, analysis and
improvement processes needed b) is effectively implemented
and maintained.
a) to demonstrate conformity to service
requirements, An audit programme shall be planned, taking
into consideration the status and importance
of the processes and areas to be audited, as
well as the results of previous audits.
17
The audit criteria, scope, frequency and 8.2.4. Monitoring and measurement
methods shall be defined. The selection of of service
auditors and conduct of audits shall ensure
objectivity and impartiality of the audit process. The NMRA shall monitor and measure the
Auditors shall not audit their own work. characteristics of the service to verify that
service requirements have been met. This
A documented procedure shall be established shall be carried out at appropriate stages of
to define the responsibilities and requirements the service realization process in accordance
for planning and conducting audits, with the planned arrangements (see 7.1).
establishing records and reporting results. Evidence of conformity with the acceptance
Records of the audits and their results shall criteria shall be maintained.
be maintained.
Records shall indicate the person(s)
The management responsible for the area authorizing release of product for delivery to
being audited shall ensure that any necessary the customer (see 4.2.4).
corrections and corrective actions are taken
without undue delay to eliminate detected The release of product and delivery of service
nonconformities and their causes. to the customer shall not proceed until the
planned arrangements (see 7.1) have been
Follow-up activities shall include the satisfactorily completed, unless otherwise
verification of the actions taken and the approved by a relevant authority and, where
reporting of verification results. applicable, by the customer.
8.2.3. Monitoring and measurement 8.3. Control of nonconforming

of processes product
The NMRA shall apply suitable methods The NMRA shall ensure that product, including
for monitoring and, where applicable, regulated product, which does not conform
measurement of the quality management to product requirements is identified and
system processes. These methods shall controlled to prevent its unintended use or
demonstrate the ability of the processes to delivery. A documented procedure shall be
achieve planned results. established to define the controls and related
responsibilities and authorities for dealing with
When planned results are not achieved, nonconforming product.
correction and corrective action shall be taken,
as appropriate. Where applicable, the organization shall deal
with nonconforming product by one or more of
NOTE: the following ways:
When determining suitable methods, it is
advisable that the NMRA consider the type a) by taking action to eliminate the
and extent of monitoring or measurement detected nonconformity;
appropriate to each of its processes in relation
to their impact on the conformity to product
requirements and on the effectiveness of the
18
b) by authorizing its use, release c) characteristics and trends

or acceptance under concession by of processes and products,
a relevant authority and, including opportunities for
where applicable, by the customer; preventive action (see 8.2.3 and
8.2.4), and
c) by taking action to preclude its
original intended use or application; d) suppliers (see 7.4).
d) by taking action appropriate 8.5. Improvement

to the effects, or potential effects,
of the nonconformity when 8.5.1. Continual improvement
nonconforming product is detected
after delivery or use has started. The NMRA shall continually improve the
effectiveness of the quality management
When nonconforming product is corrected system through the use of the quality policy,
it shall be subject to re-verification to quality objectives, audit results, analysis of
demonstrate conformity to the requirements. data, corrective and preventive actions and
management review.
Records of the nature of nonconformities
and any subsequent actions taken, including 8.5.2. Corrective action
concessions obtained, shall be maintained
(see 4.2.4). The NMRA shall take action to eliminate the
root causes of nonconformities in order to
8.4. Analysis of data prevent recurrence.
The NMRA shall determine, collect and Corrective actions shall be appropriate to the
analyse appropriate data to demonstrate the effects of the nonconformities encountered.
suitability and effectiveness of the quality A documented procedure shall be established
management system and to evaluate where to define requirements for
continual improvement of the effectiveness of
the quality management system can be made. a) reviewing nonconformities (including
customer complaints),
This shall include data generated as a result of
monitoring and measurement and from other b) determining the causes of
relevant sources. nonconformities,
The analysis of data shall provide information c) evaluating the need for action to
relating to: ensure that nonconformities do not
recur,
a) customer satisfaction (see 8.2.1),
d) determining and implementing
b) conformity to product requirements action needed,
(see 8.2.4),
e) records of the results of action taken
(see 4.2.4), and
19
f) reviewing the effectiveness of the REFERENCES

corrective action taken
. ISO 9000:2005(E) - Quality Management
8.5.3. Preventive action System - Fundamentals and vocabulary, 3rd
edition
The NMRA shall determine action to eliminate
the causes of potential nonconformities in ISO 9001:2008(E) - Quality Management
order to prevent their occurrence. Preventive System - Requirements, 4th edition
actions shall be appropriate to the effects of
the potential problems. ISO/IEC 17020:2012(E) - Conformity
assessment-Requirements for the
A documented procedure shall be established operation of various types of bodies
to define requirements for performing Inspection, 2nd edition
a) determining potential ISO/IEC 17025: 2005(E) - General

nonconformities and their causes, requirements for the competence of testing
b) evaluating the need for action to and calibration laboratories, 2nd edition
prevent occurrence
of nonconformities, PI 002_3: 2007 PIC/S - Recommendation
on Quality system requirements for
c) determining and implementing pharmaceutical inspectorates
action needed,
d) records of results of action taken,

and
e) reviewing the effectiveness of the

preventive action taken.
REVISION HISTORY
Revision No Date Author Section(s) Description Approvals

revised of change
0 This is the
first edition.
20
PART TWO:
EAC GUIDLINES FOR IMPLEMTATION OF QMS REQUIRMENTS
21
0. INTRODUCTION e) processes designed to identify and

reduce wasted effort or output;
0.1. Background
f) Complete, current, clear and
One of the goals of East African Community relevant documentation.
(EAC) Medicines Regulatory Harmonization
Project is to have harmonized and functioning 0.2. Objectives
Quality Management System (QMS) within
the EAC National Medicines Regulatory The overall objective of this document
Authorities (NMRAs) in accordance with is to provide guidance to EAC partner
national and internationally recognized states in NMRAs in the establishment and
standards. This document provides guidelines maintenance of EAC QMS so as to achieve
for implementing quality management systems consistency in regulatory service delivery and
in NMRAs of the EAC. facilitate mutual confidence and recognition.
All NMRAs in the EAC have management The specific objectives of this document
systems for creating and delivering their are to:
services to customers. However, some of the
NMRAs lack quality management systems a) enable the establishment,
which would lead to wasteful processes, poor implementation and maintenance
services delivery and dissatisfied customers. of a QMS in all EAC Partner States
A quality management system significantly NMRAs in accordance with the EAC
increase the efficiency and effectiveness of QMS requirements;
the NMRA and hence, improving processes
and services delivery. b) Facilitate EAC Partner States
NMRAs to develop their quality
An efficient NMRA can be characterized by: manuals in accordance with EAC
QMS requirements
a) explicit awareness of, and concern
for, the needs of customers and 0.3. Scope of EAC Guidelines
other stakeholders (e.g. consumers, for implementing QMS
suppliers, society, staff); requirements
b) senior and middle managers who This document guides EAC Partner States
understand and focus on business NMRAs in the implementation of EAC QMS
needs; requirements.
c) a commitment to improve products

and services;
d) staff development and training

programmes that meet the needs of
the organization;
22
1. QUALITY MANAGEMENT or laws that may be published in the

SYSTEM EAC Gazette.
1. General 3. Terms and definitions
1.1. Scope For the purposes of this document, the

terms and definitions given in ISO 9000:
These guidelines apply to all directorates, 2005 apply.
departments, units and sections of the EAC
Partner States NMRAs for implementation of For the NMRAs, the following terms and
EAC QMS requirements. definitions for “product”, “customer” and “Top
Management” shall apply:
2. Normative references
a) Customer: organization or
These guidelines have been developed person that receives a product.
according to “EAC QMS requirements, 2014” EXAMPLE Consumer, client, end-
In addition, the following referenced user, retailer, beneficiary and
documents are indispensable for the purchaser.
application of the QMS:
NOTE 1:
a) ISO 9000:2005, Quality A customer can be internal or external to the
Management Systems - organization.
Fundamentals and Vocabulary.
NOTE 2:
b) ISO/IEC 17025: 2005 - General “Regulated Customer”: Organisation or person
requirements for the competence of who by the nature of their business are subject
testing and calibration laboratories to regulation by the NMRAs
c) ISO/IEC 17020: 2012 Conformity NOTE 3:

assessment - Requirements “Unregulated Customer”: Organisation or
for the operation of various types of person who is not subject to regulation by
bodies performing inspection NMRAs.
d) PI 002_3: 2007 PIC/S - b) “Outsourced process”: A process

Recommendations on Quality that the NMRA needs for its quality
system requirements for management system and which
pharmaceutical inspectorates EAC the NMRA chooses to have
Partner states application statutory performed by an external party.
and legal requirements
c) “Product” : Applies to regulatory
e) EAC Standards, Quality, services intended for, or required by,
Metrology and Testing the customer (regulated and/
(SQMT) Act (2006) - revised 2013 or unregulated customer) and
and any other recognised standard to any intended output resulting
from the product realization
23
processes of the NMRA (e.g. After initial verification that the quality
market authorization or medicine management system is capable of meeting
registration certificates, licences, customer and regulatory requirements and
permits, good manufacturing ensuring availability of safe, quality and
practice certificates, good efficacious Medicines, the NMRAs can
distribution practice certificates, maintain the effectiveness of its established
medicine/drug register) quality management system through a range
of activities, such as:
d) “Top management” person or
group of people who directs and a) internal quality audits,
controls an NMRA at the highest
level. b) management review, and
4. Quality Management System c) independent external quality audits.
4.1. General requirements Where an NMRA chooses to outsource any

process that affects product conformity to
The NMRA should establish, document, requirements, the NMRA should ensure
implement and maintain a quality control over such processes. The type and
management system that is designed to extent of control to be applied to these
provide regulatory services aimed at ensuring outsourced processes should be defined
availability of safe and effective medicines within the quality management system
and meeting customer, statutory and legal
requirements. 4.2. Documentation requirements
Statutory and legal requirements include 4.2.1 General

national (e, g National Health Policy, NMRA
Acts, etc); regional (EAC policies on medicine Documented quality management system
regulation) and international (WHO guidelines, procedures are required for applicable
etc) obligations. requirements of “EAC QMS requirements,
2014” and should be consistent with the
Implementing and maintaining an effective NMRAs’ quality policy.
quality management system is an element of
managing an NMRA, for which specific skills in It is important to recognize that the structure
quality management and other management and level of detail required in these
disciplines are necessary. procedures should be tailored to the needs of
the NMRAs, which in turn are dependent on
methods used and the skills and qualifications
of the NMRAs’ personnel performing the
activities in question (see also clause 6.2.2 of
“EAC QMS requirements, 2014”).
24
Figure 1: Hierarchy documents of internal origin1
Figure 2: Hierarchical relationship between documents of external and

internal origin2
1
Adopted from International Organization for Standardization, Geneva 2008
25
2
Adopted from Uganda National Drug Authority, Kampala 2010
Documented procedures, including work The organization should establish and

instructions and flowcharts, define activities maintain a quality manual that includes:
and usually describe:
a) the scope of the quality
a) what is to be done and by whom, management system, including
details of, and justification for,
b) when, where, why and how it is to any exclusions (see 1.2 of “EAC
be done, QMS REQUIREMENTS, 2014”);
c) what materials, equipment and b) the documented procedures

documents are to be used, established for the quality
management system, or reference
d) how an activity is to be monitored to them;
and measured, and
c) a description of the interaction
e) what records are required. between the processes of the
quality management system;
Documentation should be evaluated with
respect to the effectiveness of the quality
management system against criteria, such as: d) the NMRAs’ quality policy (showing
the NMRs’ commitment to quality);
a) functionality (processes and system)
e) a description of the NMRA (usually
b) human interfaces, in the form of an organization
structure).
c) resources required,
f) policy statements demonstrating
d) policies and objectives, and management’s intention to comply
with EAC QMS requirements (less
e) interfaces used by NMRAs’ any justified exclusion only in
customers and suppliers. section 7 of the EAC QMS
requirements).
4.2.2 Quality Management
The policies must cover all areas of the
A quality manual is a document specifying the EAC QMS requirements and be traceable
quality management system of organisation. (reference) to them. These policies must
It includes policies for all areas of the include:
business affecting or affected by the quality
system. These policies authorize department • how management expects NMRAs
managers to implement procedures within the operations to function.
boundaries specified in the quality manual.
• who is responsible to implement
They also serve to provide a measure for these expectations (by function or
procedures, processes and results. job title and description).
26
• where and when the policies are guideline, protocols and policies;
applicable within the organization. customer supplied documents etc.).
• what interdependencies exist The system established for the control of

between functions and processes. internal documents will usually:
The quality manual would normally
contain no proprietary/confidential a) assign responsibilities for
information and is usually made preparation, approval and issue of
available to customers and third documents;
party auditors.
b) include periodic review of
The quality manual would normally contain documents, as required by the
no proprietary/confidential information and is quality management system;
usually made available to customers and third
party auditors. c) identify recipients of controlled
copies of documents;
The NMRA should also have the relevant
functional level manuals for example d) define a method for recording the
the Inspectorate quality manual as per ISO/ implementation date of a document
IEC 17020:2012 and PIC/S PI002-3: 2007 change;
guidelines; the Laboratory quality manual as
per ISO/IEC17025:2005 and other functional e) ensure that changes and current
level manuals as may be required. The revision status of document are
functional level manuals should be designed identified,
to ensure harmony and consistency with the
NMRAs quality manual. f) ensure prompt withdrawal of
obsolete copies of controlled
documents;
4.2.3 Control of documents
g) ensure that documents of external
Controlled documents of the NMRA QMS origin determined by NMRA to
include: be necessary for the planning of
QMS are identified;
• Internal documents (generated
by the NMRA such as manuals, h) ensure that relevant versions of
guidelines, standard operating applicable documents are available
procedures, specifications, forms, at points of use;
reports, certificates, drug register,
guidelines, etc., and i) allow controlled and non-controlled
documents to be distinguished; and
• External documents (such as laws,
Acts, statutory regulations; j) changes to approved documents
international guidelines, regional are initiated, reviewed and approved
in accordance with the procedure
for control of documents.
27
Document control procedures can be assisted Changes to documents, including computer-

by the adoption of a consistent structure for based documents, are made by authorized
the documents within the quality management personnel (e.g. persons with an access code
system. These procedures should clearly to the document file to be changed).
indicate what document control information
should be included in each document. The approval of authorized changes is
identified in the document or in its change
Consideration should be given to the history. Prevention of unauthorized changes
inclusion of: to computer-based documents and data can
be facilitated by making “read only” copies
a) title and scope, available to persons who have a need to use
them but are not authorized to change them.
b) document reference number,
4.2.4 Control of records
c) review due date,
Records are a special type of document and
d) date of issue, should be controlled as described in this
clause. Records should be compiled, stored
e) date effective, safely, protected from unauthorized access,
and protected from unauthorized alteration by
f) date of approval the NMRAs. These records should be properly
identified, collected, indexed and filed, and
g) revision status, readily accessible if needed. They can be
stored or copied in any suitable form (e.g.
h) revision history, hardcopy or electronic media).
i) originator or author (title, name If records are retained on electronic media,

and signature), consideration of the retention times and
accessibility of the records should take into
j) person(s) approving it (title, name account the degradation of the electronic
and signature), images and the availability of devices and
software needed to access the records.
k) person(s) issuing it (title, name Such copies of records should contain all the
and signature), relevant information captured in the original
records.
l) distribution,
Hand-written entries should be made by
m) pagination, and indelible medium. Persons making authorized
entries on forms should do so in clear legible
n) computer file reference, if writing, and should confirm the entry by adding
applicable. their initials, signature or equivalent, and the
date.
28
Good recording practices require the following: NMRAs are required by EAC QMS
requirements to define the lifetime of each
a) enter data and observations as they of regulatory services. In making such a
occur, definition, the rationale should be given, but
need not be “technical’ in nature; e.g., the
b) do not pre-date or postdate records, service lifetime could have a financial or legal
basis.
c) do not use another person’s initial,
signature or equivalent, The NMRA should be responsible, through
legally enforceable commitments, for the
d) complete all fields or check-offs management of all information obtained or
when using a form, created during the performance of inspection
activities. The NMRA should inform the client,
e) refer to raw data when transferring in advance, of the information it intends to
data, and have the transcription place in the public domain.
checked by a second person,
Except for information that the client makes
f) check all entries for completeness publicly available, or when agreed between
and correctness, and the inspection body and the client (e.g. for
the purpose of responding to complaints), all
g) number the pages to ensure other information is considered proprietary
completeness. information and should be regarded as
confidential.
If an error is made or detected on a record,
it should be corrected in such a manner that NOTE:
the original entry remains legible and the Legally enforceable commitments can be, for
correction is initialled and dated. example, contractual agreements.
If appropriate, the reason for the correction When the NMRA is required by law or
should be recorded. A system should be in authorized by contractual commitments to
place which assures the integrity of electronic release confidential information, the client or
records and protects against unauthorized individual concerned should, unless prohibited
entries. by law, be notified of the information provided.
Information about the client obtained
Record retention period should take into from sources other than the client (e.g.
consideration: complainant, regulators) should be treated
as confidential.
a) lifetime of the regulatory service as
defined by the NMRAs, 5.0 Management responsibility
b) legal considerations including Top management should develop the

national statutory requirements, and strategic plan, business plan, mission, vision,
core values for the whole NMRA. QMS
c) the need or advisability of keeping requirements should be clearly identified in the
records indefinitely. strategic plan and business plan of the NMRA
29
5.1 Management commitment h) appoint the management

representative to head the QMS in
It is important to note the emphasis on the organization; and
“top management” throughout this clause.
This is intended to ensure that the quality i) appoint QMS officers (however
management system is effective as a result of named) in each directorates
commitment on the part of management at the or departments and description of
highest levels of the NMRAs. their responsibilities and authority.
Top management should ensure that 5.2 Customer focus

processes operate as an effective network.
Top management typically analyses and The NMRA should identify current and
optimizes the interaction of processes, future customer needs, to meet customer
including both realization processes and requirements and exceed customer
support processes. expectations. Top Management should ensure
that customer requirements are understood
Consideration should be given to: and met, by consultative stakeholders
meetings and compliance with documented
a) ensuring that the sequence and client service charter.
interaction of processes are
designed to achieve the desired Customer requirements are determined,
results effectively, converted into internal requirements, and
communicated to the appropriate staff in the
b) ensuring that process inputs, NMRA.
activities and outputs are clearly
defined and controlled, Top management has the responsibility to
make certain that customer requirements
c) monitoring inputs and outputs to are understood and the necessary resources
verify that individual processes are are made available, regardless of who in the
linked and operate effectively, NMRAs actually undertakes the interaction
with the customer.
d) identifying hazards and managing
risks, To successfully discharge this responsibility,
top management will have to make sure
e) conducting data analysis to facilitate that resources are available to communicate
necessary improvement of directly with customers.
processes,
Information gathering to this end could
f) identifying process owners and involve seeking direct customer input on
process implementers and giving requirements.
them responsibility and authority,
g) managing each process to achieve

the process objectives;
30
5.3 Quality policy method is to present and discuss the quality

policy at NMRAs meetings throughout the
The quality policy establishes: year. Top management’s commitment is best
communicated through its decisions and
a) a commitment to quality and actions.
the continuing effectiveness of the
quality management system to meet All employees need to understand the
customer and regulatory quality policy and how it affects them. Top
requirements, management has to ensure the NMRA
decides on the methods which will be used to
b) the context for quality objectives, achieve this understanding.
and
The quality policy also needs to be reviewed
c) how the NMRA’s objectives relate to from time to time to determine if it accurately
its customers’ requirements. reflects the current quality related goals and
objectives of the NMRAs. This review is often
It is important that the NMRAs’ quality policy carried out during the management review
be considered when preparing the overall required in 5.6.
NMRAs policies related to its business
operations (e.g., medicines registration, Top management ensures that the quality
inspection) in order to ensure that all policy: is communicated to all employees;
NMRAs policies are consistent and it is included in new employee training and
supportive of each other. training on the QMS; and it is posted in
prominent places throughout the facility. Top
The quality policy should communicate the Management reviews the quality policy at
NMRAs’ commitment to quality, and its overall each annual management review meeting to
vision of what quality means to the NMRAs’ determine the policy’s continuing suitability.
business and customers. Sub-clause 4.2.1
of the “EAC QMS requirements, 2014” 5.4 Planning
requires the NMRAs to state this quality
policy in writing. 5.4.1 Quality objectives
In order to demonstrate that the NMRAs are In order to put the NMRAs’ quality policy and
committed to implementing its quality policy, it the strategic plan .into effect, top management
will need to identify clear, overall quality goals needs to establish clearly defined quality
for the business which are directly relevant to objectives which the NMRAs can aim for.in
the NMRAs and its customers. setting objectives and any associated targets,
timeframes for achieving the targets are
Top management’s commitment to the usually established.
quality policy should be visible, active and
effectively communicated. For example, a Quality objectives should be specific,
publicly displayed copy of the quality policy measurable, attainable, realistic and time-
signed by top management is one method bound (SMART)and related to outcomes, and
which may be used to show that commitment should be aimed at Directorates/Departments/
to both employees and customers. Another Units within the NMRAs typically establish
31
Directorate/Departmental/Unit objectives e) changes required (e.g. as a result

which follow from the overall NMRAs of Management Review and/or
objectives and relate to their specific activities. corrective and preventive action).
Quality objectives provide one of the inputs
into quality management system planning. The outputs from quality management system
planning that demonstrate meeting EAC QMS
The quality objectives should be reviewed at requirements and the quality objectives may
each annual management review meeting. include:
5.4.2 Quality management system planning a) the quality manual and supporting
documentation
This clause deals with planning in two areas
of activity: b) results of gap analysis
a) with respect to the quality c) actions plans

management system, and
d) results of action plans
b) with respect to service realization.
The QMS planning should be reflected in the
In order that the quality management system strategic plan (covering five years) for the
can meet the requirements of EAC QMS entire NMRA, and annual work plans for each
requirements, most of this planning will be functional directorate or department.
at the initial stages of development and
implementation of the quality management 5.5 Responsibility, authority
system. and communication
This planning can assist the NMRAs to fulfil 5.5.1 Responsibility and authority
its quality objectives. Since quality objectives
can, and indeed should, change over time, this This requirement is usually achieved by
planning is likely to be ongoing, and can assist means of documented position descriptions
the quality management system to continue to which include responsibilities and authorities
be effective during and after changes. charts which describe the interrelation of
personnel. As this documentation forms part
Inputs into quality management system of the quality management system it has to
planning may include: be controlled (see 4.2.3). Responsibilities
and authorities (including those for
a) quality policy; substitute personnel) can also be included in
documented procedures. NMRAs can “map”
b) quality objectives; quality management system processes to
show the linkages between processes and the
c) regulatory requirements; responsibilities associated with activities to
be performed.
d) quality management system
standards; and
32
Job descriptions and the organizational should be no conflict of interest between the
structure are reviewed and approved responsibilities for the other functions and
periodically by top management for adequacy. those relating to the quality management
system. The management representative
These documents are available throughout the may, in turn, delegate responsibilities for
company to help employees understand their the quality management system to others
responsibilities and authorities. in the NMRA. However, only one member
of management may be designated by the
A responsibility matrix in accordance with NMRA top management as its management
each applicable clause in the EAC QMS representative.
requirements, showing process owner and
process implementers for the established 5.5.3 Internal communication
directorates, departments and units within the
NMRA should be developed and annexed to For a quality management system to
the Quality Manual of the NMRA. work effectively, effective communication
is essential. Top management needs to
5.5.2 Management Representative establish the processes which encourage
people within the NMRAs to communicate
The NMRA top management should appoint a at all levels, without a ‘shoot the messenger
member of organizational management as a carrying bad news’ syndrome. To be effective,
Management Representative (Head of Quality communication processes should provide the
Management Department) with responsibility ability to:
and authority to manage the QMS. He/
she reports directly to the Chief Executive a) transmit and receive information
Officer of the NMRA to enable quick decision quickly and act on it,
making and access/authorization of resources
needed by the QMS. The MR should perform b) build mutual trust,
the functions as required by EAC QMS
requirements. c) identify examples of effective
methods and approaches within the
The Management Representative should quality management system, and
coordinate all appointed QMS officers in
their functional departments for the effective d) identify opportunities for
implementation of QMS. The Directorates or improvement.
departmental QMS officers should functionally
report to the Head of Quality Management Quality management system related
Department. information should be clear and
understandable and adapted to the personnel
The functions of the Management meant to use it. Such information relates to
Representative (MR) may be totally related top management’s expectations regarding the
to quality management system activities or quality management system performance and
may be in conjunction with other functions information related to quality management
and responsibilities within the NMRA. If the system implementation and effectiveness
MR has other functions to perform, there (for example, results of internal quality audits
33
[see 8.2.2], management reviews [see The method of carrying out the review should
5.6], external assessments, and regulatory suit the NMRAs’ business practices and could
inspections). consist of:
Examples of communication methods include: a) formal face-to-face management

meetings with an agenda, minutes
a) posting information on bulletin and formally identified action points
boards; and implementation plan, and
b) holding meetings; and/ or b) partial reviews at various levels

within an NMRAs, reporting to
c) circulating information via e-mail. the executive management who
review the reports.
Internal communication can be facilitated by
personnel having familiarity with a variety of Management review records may be in any
activities or functions within the NMRAs. This form which suits the NMRAs, such as notes in
familiarity can be enhanced, for example, a daybook, formal meeting minutes or notes,
by placing personnel from one function into which can be produced, distributed and stored
another function as a part of their personal on paper or electronically.
development.
5.6.2 Review input
5.6 Management review
To ensure that the entire quality management
5.6.1 General system is covered, a consistent approach
should be followed to ensure that the review
Top management should review the covers:
quality management system on a regular
basis; annually could be acceptable for an a) the continued suitability of the
established and effective quality management quality policy and objectives with
system. If changes are planned or being respect to current needs ,
implemented, more frequent review periods
are normally needed. This review should be b) how the quality management
done before the budget preparation. system is working and whether
objectives are being met,
To ensure that the entire quality management
system is covered, with particular attention c) analysis of process performance,
being paid to those items needing
management consideration, the management d) quality problems and actions taken,
review should be carefully planned, organized,
and attended. People who participate in e) customer feedback, including
reviews should be able to contribute and take customer complaints,
action on any outcomes.
f) quality audit reports (both internal
and external),
34
g) areas for improvement/changes After identifying these issues and needs ,

needed, and depending on the outcome of the review,
the NMRA can develop and revise its quality,
h) outstanding actions from previous strategic and business plans for future
reviews, and activities. For example, as improvements
are achieved and problems eliminated, the
i) new or revised regulatory NMRA can review the nature and level of its
requirements inspection controls. Are they still essential or
can some savings be made by modifying them
Individual problems should be dealt with or adopting other controls, since the cause
as they occur, without waiting for the next of the problem has been addressed? If the
management review. The management review rate of complaints is found to be increasing, a
is intended to see if the same problems re- decision can be taken to explore the reasons
occur, if the action taken is appropriate and if and to set appropriate objectives.
the customer and regulatory requirements are
being met. Reviews and audits are not the same. This is
best understood from the fact that the results
However, the attention given to individual of audits are inputs to the management
problems should be complemented by a review.
review of the entire quality management
system in order to see if it is effective in 5.6.3 Review output
meeting the NMRAs’ quality objectives.
Review output should include a statement
Management reviews should not be devoted regarding the effectiveness of the processes
to repeatedly discussing relatively insignificant established for the achievement of the quality
problems. Rather, the management review policy and objectives, and the extent to
will be more useful if it is carefully considering which those objectives have been achieved
reports to obtain a clear overview and not just based on the established respective metrics.
reviewing a list of small details. Records of the review should address all
points of the review together with a description
Top management has to analyse and decide of any corrective or preventive action to be
on significant trends. The analysis of data taken, the responsibility for such actions, the
as required by clause 8.4 of EAC QMS resources which may be needed to complete
requirements should also be included in the such actions, and target dates for completion,
management review. Other inputs which could if known.
be considered include:
6.0 Resource management
a) training needs,
6.1 Provision of resources
b) supplier problems, and
The provision and maintenance of adequate
c) equipment needs, working resources is a prerequisite to the effective
environment and maintenance. initiation, maintenance, and management of
quality management system processes. The
nature and quantity of such resources will be
35
determined by the processes involved. quality audit (clause 8.2.2) are all likely to
Consideration needs to be given by the identify areas which could indicate a need
NMRAs’ management to the identification for improving the competence of personnel
and provision of adequate resources needed and the means for such improvement, be it
to implement its quality policy and to achieve replacement of personnel, further education
its objectives, as well as to satisfy customer or training.
requirements inclusive of applicable regulatory
requirements. All regulatory activities require competence
before they can be performed properly or
Resources can be people, infrastructure, safely (e.g. medicines evaluation, GMP
work environment, information, and financial inspection, internal quality auditing). It may
resources. Responsibility for provision of be necessary for people to be qualified or
resources resides with the NMRAs regardless formally certified for some activities.
of whether associated processes are Education and training provided for full time,
performed by the NMRAs itself or outsourced. part-time, and contract personnel, should be
tailored to the person’s assignment.
Types of resources - financial, human,
physical and technological resources Such training and education should cover:
6.2 Human Resources a) the nature of the business,
6.2.1 General b) applicable regulations,
Personnel performing work affecting c) the quality policy and other internal
conformity to product requirements should policies,
be competent on the basis of appropriate
education, training, skills and experience. d) the role of the employee, and
Conformity to service requirements can be
affected directly or indirectly by personnel e) the procedures and instructions of
performing any task within the quality relevance to them.
management system.
Training may be carried out in stages, and
6.2.2 Competence, awareness usually includes follow-up or refresher
and training training, induction training, specific on job
training, follow-up training and refresher
The NMRAs needs to regularly review the training as needed and planned. Persons and
experience, qualifications, capabilities and functions who are assigned responsibility via
abilities of personnel, especially in those areas the documented procedures of the quality
which can affect the safety and effectiveness management system, should receive training
of the regulated services. on those procedures.
Work allocation and assignment of personnel NMRAs should evaluate the effectiveness
(clause 6.2.1), management review (clause of training or other actions taken in order to
5.6), corrective action (clause 8.5.2), ensure competency. Evaluation can consist
preventive action (clause 8.5.3) and internal of polling the trained employee to assess
36
whether he or she feels they have learned g) should establish a mechanism for
the required information, evaluating the work declaration and regular update
performance of the trained individual, and of personal interest. This interest
reviewing the trainer assessment of training should periodically be reviewed to
effectiveness. identify potential conflict of interest.
NMRAs should maintain records which show h) The NMRA should ensure
what competencies an employee possesses. declaration of interest by staff
Records are also kept of the training an and external experts with a
employee has received and any results of clearly defined scope. This may
that training. There cords which show that be in form of completion of
the training course has been successfully declaration form before engaging in
completed and that competence has been business dealing with the regulated
achieved can be as simple or complex as products.
necessary. At their simplest, the records
may consist of ‘sign-off’ to confirm that i) The NMRA should identify areas of
personnel can now use certain equipment, potential risks of impartially e.g.
carry out specific processes or follow certain where NMRA staff are performing
procedures. The records should include a regulatory functions with an external
clear statement that a person is now deemed party and establish mechanisms to
to be competent to do the task for which they mitigate them
were trained. The effectiveness of any further
education and training should be re-evaluated j) The NMRA should identify areas of
after a period, to ensure competence achieved interest to be declared by staff and
and continued competence of the staff. external experts’ namely financial
interests, work related to the
Training should be carried out by personnel regulated industry including
with appropriate skills, qualifications and pharmaceutical, food, cosmetic
experience. Records are typically kept to industry and links to any other
document the qualifications of the personnel industry related to the areas
used as trainers. The level of documentation regulated.
required for processes is usually determined
by the level of competence required for the 6.2.4 Confidentiality
personnel intended to perform that process.
a) The NMRA should identify areas
6.2.3 Impartiality and independence that require confidentiality and
review them on periodic basis e.g.
f) The NMRA Top management should personal data, client and customer
establish core values that include confidential information like patient
impartiality, independence and data, drug master file. .This should
equity, and proactively communicate not unnecessarily impede public
and ensure all staff understand right of access to information.
them.
37
b) The NMRA should have a supporting services (such as

mechanism for declaration of transport, communication or
confidentiality in accordance to information systems).
existing provisions of the relevant
laws. As new infrastructure requirements arise,
they will be documented in quality plans.
c) The NMRA should establish Existing infrastructure is maintained to ensure
a communication policy on material / product conformity. Maintenance
information generated within the requirements are documented in preventive
organization taking into maintenance plans, sanitation plans and
consideration the legal building maintenance plans.
requirements, intellectual property
rights and personal data 6.4 Work environment
d) The NMRA should ensure Quality of services can be influenced by

confidential client information e.g. the service delivery work environment.
product dossiers, is handled Work environment relates to those conditions
and stored in an appropriate and under which work is performed including
secure environment. physical, environmental and other factors
(such as noise, temperature, humidity,
6.3 Infrastructure lighting or weather, organization culture,
confidentiality, motivation and rewarding
The NMRAs should ensure that buildings, system, capacity/skills development).
workspace and associated utilities, process
equipment (both hardware and software), 7.0 Product realization
and support services (such as transport,
communication or information systems) The NMRA should provide regulatory services
are adequate and effectively utilized and as indicated in the service charter within the
maintained. specified timelines. The regulatory services
includes: Inspection and enforcement,
Documented procedures should be available evaluation and registration of medicines,
for maintenance of buildings and associated cosmetics and medical devices, licensing
utilities, process equipment and support of premises, cGMP, Pharmacovigilance,
services. clinical trials, import and export control,
laboratory quality control testing and analysis,
The NMR should determine, provide and public education and information sharing on
maintain the infrastructure needed to regulated products and services.
achieve conformity to product requirements.
Infrastructure includes, as applicable, Provision of services should be in line with
existing legal and statutory requirements
a) buildings, workspace and within the EAC partner states NMRAs.
associated utilities,
b) process equipment (both hardware

and software), and c)
38
7.1 Planning of services realization 7.2 Customer related process
Consistent with 5.4.2 of EAC QMS 7.2.1 Determination of requirements

requirements, which requires the planning of related to the service
the quality management system, clause 7.1 of
EAC QMS requirementsrequires the planning The NMRA should determine:
of the processes related to the realization of
service. a) requirements specified by the
customer, including the
In planning of product realization the NMRA requirements for delivery and post-
should consider the scope of its quality delivery activities. This can be
management system. done through having consultative
meetings, circulars, training
In planning product realization the following workshops, seminars, feedback
should be considered: (suggestion) boxes,
a) Quality objectives and requirements b) requirements not stated by

for the product; the customer but necessary for
specified or intended use, where
b) the need to establish processes and known such examples could
documents, and to provide include staff and partners
resources specific to the product; recommendation on improvement
service delivery,
c) required verification, validation,
monitoring, measurement, c) statutory and regulatory
inspection and test activities specific requirements applicable to the
to the product and the criteria for product .These may be
product acceptance; obtained from national, regional
(e.g.EAC Standardization, Quality
d) records needed to provide evidence Assurance, Metrology and Testing
that the realization processes and Act) and international laws and
resulting product meet requirements regulations, and
(see 4.2.4 as appropriate).
d) any additional requirements
The output of this planning should be in a considered necessary by the NMRA
form suitable for the organization’s method which may include internally
of operations. generated requirements.
There is need to establish documented 7.2.2 Review of requirements related to

requirements for risk management throughout the services
the service realization and that records of
same are to be maintained. The key elements The NMRA should review the requirements
of risk management include risk analysis, risk related to provision of the services to the
evaluation, and risk control. customers. These may include requirements
for licensing, product registration and market
39
authorization, approvals/permits, GMP and, if possible, the NMRAs should develop

inspection and others. communication processes and should appoint
someone to liaise with the customers.
This review should be conducted prior to the
organization’s commitment to supply a product 7.2.4 Complaints and appeals
to the customer and should ensure that:
Customer complaints and appeals are the
a) product requirements are defined, most common indicators of service deficiency
which may be subject to correction and
b) product requirements differing from corrective or preventive action to prevent
those previously expressed are recurrence of the problem. Any customer
resolved, and complaint and appeal received by the NMRAs
on a service should be evaluated. Customer
c) the NMRA has the ability to meet complaints and appeals can be of either
the defined or new requirements. internal or external origin
Records of the results of the review and Each directorate, department or unit of the
actions arising from the review should NMRA should consider each other within
be maintained (clause 4.2.4). Where the the same NMRA to be customers. In this
customer provides no documented statement case internal complaints can be treated
of requirement, the customer requirements as customer complaints and processed
should be confirmed by the organization accordingly. If non-conforming service
before acceptance. is involved, this should also be handled
according to the requirements of clause 8.3 of
7.2.3 Customer communication the “EAC QMS Requirements, 2014”.
The NMRA should determine and implement In evaluating the complaints and appeals, it
effective arrangements for communicating with should be considered whether:
customers in relation to:
a) the service fails to conform to its
a) Service information. This can be in specification, or
form of guidelines, circulars,
forms etc. to the stakeholders, b) conforms to its specifications but
importers, manufacturers and the nevertheless causes problems in
general public, use (such a complaint may be
caused by design fault).
b) enquiries, new service information
including amendments, and The NMRAs should formally designate a
person(s) (by role or position) to collect and
c) customer feedback, including coordinate all written and oral customer
customer complaints complaints and appeals about regulatory
services. Such person(s) should directly report
Good communication between the NMRAs to the Head of NMRA.
and the customer is essential to identify,
mitigate and resolve any misunderstandings,
40
The documented complaints and appeals g) the corrective action taken,

system should cover the following:
h) the justification if no action is taken,
a) establishing responsibility,
i) the dates of the investigation,
b) evaluating the complaint and
appeals, j) the name of the investigator, and
c) creating records and statistical k) the reply (if any) to the complainant
summaries to enable the major or appellant.
causes of complaints and appeals
to be determined, 7.2.5 Complaints and appeals process
d) taking any corrective action, The NMRA should have a documented

process to receive, evaluate and make
e) filing of customer correspondence decisions on complaints and appeals.
and other relevant records (the A description of the handling process for
retention time for these should be complaints and appeals should be available to
defined), and any interested party upon request.
f) the records of complaint and Upon receipt of a complaint and appeal,

appeals investigations should the NMRA should confirm whether the
contain enough information to show complaint relates to its activities for which it is
that the complaint and appeals responsible and, if so, should deal with it.
was properly reviewed, for example
a determination of whether or not The NMRA should be responsible for all
there was an actual service failure decisions at all levels of the handling process
to perform as per specifications. for complaints and appeals.
An investigation record typically includes: Investigation and decision on appeals should

not result in any discriminatory actions.
a) the name of the service,
The handling process for complaints and
b) the date the complaint or appeal appeals should include at least the following
was received, elements and methods:
c) the control number used, a) a description of the process for

receiving,
d) the name and address of the
complainant or appellant, b) validating,
e) the nature of the complaint and c) investigating the complaint or

appeal, appeal, and deciding what actions
are to be taken in response to it,
f) the results of the investigation,
41
d) tracking and recording complaints solutions of the problem without bias

and appeals, including actions or judgment;
undertaken to resolve them, and
b) the review, verification and
e) ensuring that any appropriate action validation that are appropriate to
is taken. each design and development
stage, and;
The NMRA should be responsible for
gathering and verifying all necessary c) the responsibilities and authorities
information to validate the complaint or for design and development.
appeal.
The NMRA should manage the interfaces
Whenever possible, the NMRA should between different groups involved in design
acknowledge receipt of the complaint or and development to ensure effective
appeal, and should provide the complainant communication and clear assignment of
or appellant with progress reports and the responsibility. Planning output should be
outcome. updated, as appropriate, as the design and
development progresses.
The decision to be communicated to the
complainant or appellant should be made by, Design and development review, verification
or reviewed and approved by, individual(s) not and validation have distinct purposes. They
involved in the original activities in question. may be conducted and recorded separately
Whenever possible, the NMRA should give or in any combination, as suitable for the
formal notice of the end of the complaint and regulatory services and the NMRA
appeals handling process to the complainant
or appellant. 7.3.2 Design and development inputs
7.3 Design and Development Inputs relating to regulatory service

requirements should be determined and
7.3.1 Design and development records maintained. These inputs should
planning include:
The NMRA should plan and control the design a) functional and performance
and development of regulatory services. requirements which include
During the design and development planning, registration and inspection
the NMRA should clearly define: requirements; timely delivery and
quality of service,
a) the stages of design and
development of regulatory b) applicable statutory and regulatory
services by analysing the current requirements namely the drug
situation, conceptualizing key issues laws, new regulations on
of the service, defining the registration and inspections for the
objectives and parameter within regulated products,
which the new service should be
designed; brainstorm ideas and
42
c) where applicable, information b) characteristics of equipment,

derived from previous sources of literature as appropriate
similar designs, and
c) characteristics of the service such
d) other requirements essential as reliability, availability and
for design and development like timeliness
customer requirements.
d) Templates of the reports,
The inputs should be reviewed for adequacy. checklists, templates for certificates
Requirements should be complete, (physical characteristics).
unambiguous and not in conflict with each
other. e) Specifications of the competency
(education, skills) of an inspector.
7.3.3 Design and development outputs
f) Attributes of the inspectors for
The outputs of design and development example courtesy, honesty and
should be in a form suitable for verification veracity (behavioural) reliability,
against the design and development input and punctuality and availability
should be approved prior to release. (temporal), punctuality; and
a) Design and development outputs g) Inspection fees

should:
Design output for product registration service
b) meet the input requirements for includes;
design and development,
a) steps/description of the registration
process
c) provide appropriate information
for purchasing, production and b) characteristics of equipment,
service provision, sources of literature as appropriate
c) characteristics of the service such

d) contain or reference regulatory as reliability, robustness and
service acceptance criteria, and timeliness
e) specify the characteristics of the d) Templates of the reports,

regulatory service that are essential checklists, templates for certificates
for its safe and proper use. (physical characteristics).
Design output for inspection service includes: e) Specifications of the competency

(education, skills) of an evaluator.
a) steps/description of the inspection
process; f) Attributes of an evaluator for
example, honesty, integrity,
43
diligence and veracity (behavioural) intended purpose. Wherever practicable,

reliability, and availability (temporal) validation should be completed prior
implementation of the regulatory service.
g) Product Registration fees Records of the results of validation and any
necessary actions should be maintained.
7.3.4 Design and development review Pilot the designed regulatory services by
performing several inspections or registrations
At suitable stages, systematic reviews of and evaluate the result of the service before
design and development should be performed implementation.
in accordance with planned arrangements:
7.3.7 Control of design and
a) to evaluate the ability of the results development changes
of design and development to meet
statutory and customer Design and development changes should
requirements be identified and records maintained. The
changes should be reviewed, verified and
b) to identify any problems and validated, as appropriate, and approved
propose necessary actions. before implementation.
Participants in such reviews should include The review of design and development
representatives of functions concerned with changes should include evaluation of the
the design and development stage(s) being effect of the changes on constituent parts and
reviewed. Records of the results of the regulatory services already delivered. Records
reviews and any necessary actions should be of the results of the review of changes and
maintained. any necessary actions should be
7.3.5 Design and development 7.4 Purchasing

verification
Verification should be performed in
accordance with planned arrangements to The NMRA should have a documented
ensure that the design and development procedure for purchasing to ensure that
outputs have met the design and development purchased material/product/services conform
input requirements. Records of the results of to the specified purchase requirements.
the verification and any necessary actions The procedure should require terms and
should be maintained. conditions in the contract for supply of goods
and services to outline the extent of control
7.3.6 Design and development required for suppliers. Suppliers should be
validation evaluated and selected based on their ability
to supply material/product in accordance with
Design and development validation should requirements as outlined in the procedure.
be performed in accordance with planned
arrangements to ensure that the resulting Criteria for selection, evaluation and re-
regulatory service is capable of meeting the evaluation should be documented in the
statutory and customer requirements for the contract. Records of the evaluation and any
44
necessary actions should be maintained as When monitoring the performance of

quality records according to the procedure for suppliers, the NMRAs should consider a
control of records. supplier’s third party certification status,
compliance trends, and conformance history.
Procurements in most NMRAs are regulated The NMRAs should define the frequency of
by national laws. The NMRA should therefore such performance monitoring. The NMRAs
comply with such applicable national legal should also include in the supplier monitoring
procurement requirements. activities the need for their registration body to
visit the supplier for the purpose of obtaining
The selection of suppliers is a process objective evidence that the outsourced
consisting of establishing criteria for, processes are under control and that the
evaluating; selecting and on-going monitoring services or product conform to the NMRAs’
of a supplier. The application of the process specified requirements which may include
should be commensurate with the service or customer and regulatory requirements.
service being purchased. The NMRAs’ purchasing data should define
appropriate specifications to the supplier to
An evaluation can range from auditing of the ensure the quality of the purchased service
supplier’s quality management system by (including technical service requirements),
the NMRAs, to the acceptance of evaluation calibration services, and inspection and
reports or approval by reference to historical test activities (including record keeping
data like records of past performance, certified requirements).
services, or quality management system
registration. The NMRAs can make reference to applicable
technical information such as national or
Regardless of the method of evaluation, the international standards/regulations, test
NMRAs is required to demonstrate that they methods, etc. Another approach is for
have control over the outsourced process by information to be clearly and precisely
possessing objective evidence that formal stated to the supplier on the purchase order.
consideration was given to the evaluation of Responsibility for reviewing and approving the
the outsourced process, and that the selection purchasing data should be clearly assigned to
of a supplier was based on appraisals appropriate personnel to prevent purchasing
appropriate to the service or service being incorrect materials. The revision status of
purchased and the supplier’s ability to documents referenced in the purchasing data
enable the NMRAs to meet the customer should be identified to ensure that the correct
and regulatory requirements of the regulated version of materials is purchased.
product.
45
Purchasing documents and records may need This check may be accomplished by various
to be identified and retained for traceability approaches, such as qualification of suppliers,
purposes to the extent required by the certificates of conformance, skip lot testing,
NMRA. This means that when evaluating the 100 % or sampling inspection, as determined
traceability requirements, consideration should by the requirements of the NMRAs’ quality
be given to what purchasing information management system.
and records may also need to be retained
to facilitate traceability. For example, if it The NMRAs’ procedures should specify
was important to know to what specification the method of verifying that consignments
revision a purchased services was ordered, received are in accordance with specifications,
then this information should be kept as part of are complete, have proper identity and
the purchasing documents or records. are undamaged. The procedures should
also include provisions for verifying that
7.4.2 Purchase Information incoming service is accompanied by the
required supporting documentation (e.g.
The NMRA should ensure the adequacy of certificates of conformity, acceptance test
specified purchase requirements prior to reports, etc.). Appropriate action in the event
communication to the supplier per process of nonconformities should be specified (see
defined in procedure procurement document. clause 8.3) so that they can be dealt with
Purchase information communicated to in a consistent manner and without undue
the suppliers contains the appropriate delay, including identification, segregation and
data needed to clearly and fully describe documentation
requirements for purchased materials
and services including suppliers profiles Analysis of previous receiving inspection
requirements, approval or qualification of data, in-house rejection history or customer
product as well as QMS requirements. complaints will influence the NMRA’s decisions
regarding the amount of inspection required,
7.4.3 Verification of purchased product and the need to reassess a supplier.
Verification of purchased service does
The NMRA has an overall responsibility for not imply that incoming service has to
ensuring the quality of purchased products. be inspected and tested by the NMRAs.
Inspection of purchased product for conformity Incoming inspection may not be required if
of purchase specification is important for the the necessary confidence in the service can
NMRAs to ensure that the purchased product be obtained by other defined processes or
fulfils specified requirements for quality. If the procedures, particularly if the information
purchased service is claimed to conform to given by a supplier is considered sufficient.
the supplier’s specification, the NMRAs should The NMRAs’ procedures should define who
check that the service meets the agreed is authorized to allow incoming service to
specification. be used before conformance to specified
requirements for quality is demonstrated.
46
Such a procedure ensures that the decision The NMRA should plan and carry out service
is being taken at a level in the NMRAs which provision under controlled conditions.
is aware of the possible impact on service
realization if the incoming services do not Controlled conditions should include,
subsequently meet the requirements.
a) the availability of information that
The NMRAs’ procedures should also define describes the characteristics of the
how such service will be positively identified service,
and controlled in the event that subsequent
inspection finds nonconformities, in order to b) the availability of work instructions,
facilitate corrective action. These requirements as necessary,
apply to all services received from outside the
NMRAs’ quality management system, whether c) the use of suitable equipment,
payment occurs or not.
d) the availability and use of monitoring
Outsourced services should be subjected to and measuring equipment,
the same procedure as described above.
Ensuring control over outsourced processes e) the implementation of monitoring
does not absolve the organization of the and measurement, and
responsibility of conformityto all customers,
statutory and regulatory requirements. f) the implementation of service
delivery and post-delivery activities.
The type and extent of control to be applied to
the outsourcedprocess can be influenced by 7.5.2 Validation of processes for
factors such as: production and service provision
a) the potential impact of the 7.5.2.1 General requirements

outsourced process on the
organization’s capability to provide The validation of a process is the mechanism
product that conforms to or system used by NMRAs to plan, obtain
requirements, data, record data, and interpret data
associated with a particular process.
b) the degree to which the control for
the process is shared, These activities can be considered to fall into
a model consisting of four phases:
c) the capability of achieving the
necessary control through the a) review and approval of service
application of 7.4. specifications/requirements;
7.5 Production and service provision b) an initial qualification of the

equipment used and provision
7.5.1 Control of production and service of necessary services - also known
provision as installation qualification (IQ)
e.g. equipment for Management
Information System (MIS);
47
c) a demonstration that the 7.5.2.2 Statistical methods and tools for

process will produce acceptable process validation
results and establishment of limits
(worst case) of the process There are many methods and tools which can
parameters - also known as be used in process validation. Control charts,
operational qualification (OQ); and capability studies, designed experiments,
tolerance analysis, robust design methods,
d) and establishment of long term failure modes and effects analysis (FMEA),
process stability - also known as sampling plans, and mistake-proofing are
performance qualification (PQ). some of the examples.
When validation is performed either by the 7.5.2.3. Computer software used in

NMRAs or supplier, the validation should process control
include the following:
The requirements of the “EAC QMS
a) the accuracy and variability of the Requirements, 2014” regarding the validation
process parameters, including the of the application of computer software (e.g.
settings of the equipment used, MIS) used in process control apply, whether
or not such software is purchased, developed,
b) the skill, capability and knowledge maintained, or modified for automated service
of personnel to conform to or process control purposes. Guidance on
quality requirements, the validation of the application of computer
software is available in, for example, Good
c) the adequacy of control of any Automated Manufacturing Practice (GAMP)
specific environmental parameters, guidelines.
d) the certification records maintained
for personnel e.g. inspectors, 7.5.3 Identification and traceability
processes and equipment, as
appropriate, and To ensure identification and traceability of
EAC NMRAs’ products, NMRA should develop
e) the appropriateness of the process a procedure for Identification and Traceability.
result. The NMRA should control the unique
identification of the certificates, licenses,
Any change applied to a service delivery permits and product registration numbers
process has to include the consideration for given to its customers and maintain records.
conducting process revalidation and/or for
conducting revalidation of the service being 7.5.4 Customer property
produced by the process.
The NMRAs should identify responsibilities in
Some processes require that personnel relation to property and other assets owned
to have extra training and/or be specially by customers but are under the control of the
qualified or the process itself should have NMRAs, in order to protect the value of the
specific approval. property.
48
Examples of such property are: The NMRA should preserve the product
during internal processing and delivery to
a) samples e.g. drug samples taken for the intended destination in order to maintain
QC testing purposes, confiscated conformity to requirements. As applicable,
drugs and market authorization preservation should include identification,
product samples, handling, packaging, storage and protection.
Preservation should also apply to the
b) dossiers and applications forms, constituent parts of a product.
c) services provided on behalf of the 7.6 Control of monitoring and

customer (such as transport of measuring equipment
customer property
to a third party), and The intent of the requirements is to give the
NMRAs confidence in the monitoring and
d) customer intellectual property measuring equipment which it uses to ensure
(including specifications, that what is being controlled meets customer
drawings, site master files for and regulatory requirements.
pharmaceutical manufacturing
facilities and proprietary NMRAs should determine the monitoring
information). and measurement to be undertaken and the
monitoring and measuring equipment needed
e) Pro-forma invoices, to provide evidence of conformity of product to
determined requirements.
f) drug promotional materials,
The NMRA should establish processes to
g) certificates, and ensure that monitoring and measurement can
be carried out and are carried out in a manner
h) other information and that is consistent with the monitoring and
documentation supplied by the measurement requirements.
customer.
Where necessary to ensure valid results,
The NMRAs retains the responsibility for the measuring equipment should:
protection and preservation (see clause
7.5.5)of customer property awaiting further a) be calibrated or verified, or
processing when it provides these to both, at specified intervals, or prior
external body e.g. external laboratory for to use, against measurement
services such as product testing and analysis. standards traceable to international
or national measurement standards;
7.5.5 Preservation of product where no such standards exist, the
basis used for calibration or
The top Management of EAC NMRAs should verification should be recorded (see
define and implemented processes for clause 4.2.4);
ensuring the integrity of the organization’s and
customer products. b) be adjusted or re-adjusted as
necessary;
49
c) have identification in order to The requirements of this clause also should

determine its calibration status; be applied by the NMRAs when demonstrating
the conformity of the service to the specified
d) be safeguarded from adjustments requirements.
that would invalidate the
measurement result; Documented procedures should include
details of equipment type, unique
e) be protected from damage and identification, and location, frequency of
deterioration during handling, checks, check method, and acceptance
maintenance and storage. criteria.
In addition, the NMRA should assess and Where appropriate, measurement equipment
record the validity of the previous measuring having a significant influence on the results
results when the equipment is found not to of the inspection should be calibrated
conform to requirements. The NMRA should before being put into service, and thereafter
take appropriate action on the equipment and calibrated according to an established
any product affected. programme.
Records of the results of calibration and The overall programme of calibration of

verification should be maintained (see equipment should be designed and operated
clause 4.2.4). so as to ensure that, wherever applicable,
measurements made by the inspection body
When used in the monitoring and are traceable to national or international
measurement of specified requirements, the standards of measurement, where available.
ability of computer software to satisfy the
intended application should be confirmed. This Where traceability to national or international
should be undertaken prior to initial use and standards of measurement is not applicable,
reconfirmed as necessary. the inspection body should maintain evidence
of correlation or accuracy of inspection results.
Confirmation of the ability of computer Reference standards of measurement held
software to satisfy the intended application by the inspection body should be used for
would typically include its verification and calibration only and for no other purpose.
configuration management to maintain its Reference standards of measurement
suitability for use. should be calibrated providing traceability
to a national or international standard of
Statistical methods are important in showing measurement.
which monitoring and measuring devices
are used in a manner which ensures Where relevant, equipment should be
measurement uncertainty is known and is subjected to in-service checks between
consistent with the required measurement regular recalibrations.
capability.
Reference materials should, where possible,
be traceable to national or international
reference materials, where they exist.
50
8.0 Measurement, analysis and Examples of customer-related information that

improvement demonstrtes whether or not the requirements
of customers and other interested parties have
8.1 General been met include:
The EAC NMRAs top management should a) customer and user surveys,
define, plan and implement procedures:
b) feedback on aspects of service,
a) to measure, monitor and analyse
work processes and products, c) customer complaints ,
and functioning of the QMS (e.g., to
measure effectiveness in meeting d) customer requirements and contract
customer requirements); information,
b) to identify system improvement e) market needs,

opportunities (e.g., revising
work product requirements to better f) regulatory agency compliance-
reflect customer needs); and, related communications,
c) to analyse, track, and trend g) peer-reviewed journals, service

complaints and feedback, corrective delivery data.
actions, and to identify system
problems h) information relating to competition.
8.2 Monitoring and measurement 8.2.2 Internal audit
8.2.1 Customer Satisfaction The NMRA should conduct internal audits at

planned intervals but at least once every year
Management should recognise that many to determine whether the quality management
sources exist for obtaining customer-related system:
information. This information is useful for
providing feedback related to the quality of a) conforms to the planned
services. The NMRAs should identify relevant arrangements (see clause 7.1),
sources of such information and establish to the EAC QMS requirements
an effective process to collect, analyse and and to the quality management
use the information for monitoring quality
problems. The process established has to be system requirements established by
documented, so that regulatory requirements the NMRA, and
are met.
b) is effectively implemented and
maintained.
51
In addition to the periodic internal quality Internal audits can be partially or fully
audits, a special internal quality audit may be subcontracted.
initiated for the following purposes:
The results of audits are usually stated in
a) when evaluating the quality a written report (see clause 4.2.4) which
management system initially; indicates the deficiencies found. Avoiding
undue delay is usually accomplished by
b) when verifying that the quality including appropriate target dates for
management system continues responding to audit findings. The audit results
to meet specified requirements and have to be communicated, and should be
is being implemented; used as an input to management reviews (see
clause 5.6.2).
c) when undergoing significant
changes in functional areas, for 8.2.3 Monitoring and measurement of
example, revising procedures; processes
d) when investigating safety, The NMRA should apply suitable methods

performance or dependability for monitoring and, where applicable,
of the services which are, or which measurement of the quality management
are suspected to be, in jeopardy system processes. These methods should
due to nonconformities; and demonstrate the ability of the processes
to achieve planned results. When planned
e) when verifying which required results are not achieved, correction and
corrective actions have been taken corrective action should be taken, as
and have been effective. appropriate.
Planning for internal quality audits should be When determining suitable methods, it is
flexible in order to permit changes in emphasis advisable that the NMRA consider the type
based on findings and objective evidence and extent of monitoring or measurement
obtained during the audit. appropriate to each of its processes in relation
to their impact on the conformity to service
Relevant input from the area to be audited, requirements and on the effectiveness of the
as well as from other interested parties such quality management system.
as customers, corporate audit plans, or
third-party assessment NMRAs, should be The NMRA should develop procedures for
considered in the development of internal monitoring and measuring of the processes
audit plans. All NMRA functional areas as well services provided to the customer.
including the QMS directorate or department
(however named) should be audited. Each step of the implementation process
should be measured based on the different
A series of limited, well-defined audits can levels of results in the monitoring and
be as effective as one single comprehensive evaluation framework. Mechanisms to be
audit. Such an audit system can be operated adopted monitoring and measurement of
flexibly to give special, or repeat, attention to processes include; peer review, second
any areas of weakness or of other concern. assessment.
52
The design to be adopted include quantitative 8.3 Control of nonconforming

for tangible and qualitative for non-tangible product
aspects of process; inputs, activities, outputs,
outcomes and impact. The management of the NMRAs should
ensure the establishment and implementation
The information generated from the monitoring of an effective process and SOP to provide
and measurement processes should guide the for review and disposition of identified
management in the decision making process nonconformities. Nonconforming product
and process improvement. Decisions made by includes nonconforming service occurring
the management should be in a standardized in the NMRAs’ own facilities as well as to
format and should be validated before release. nonconforming product received by the
NMRAs.
Dimensions of quality of service to be
monitored and measured may include: time Staff in the NMRAs should be encouraged
and timeliness, completeness, consistency, to report nonconformities at any stage of a
and accuracy. process in order to ensure timely detection
and disposition of nonconformities.
8.2.4 Monitoring and measurement of
product Procedures established and maintained by the
NMRAs should have the following purposes:
The NMRA should monitor and measure the
characteristics of the service to verify that a) to determine which product is
service requirements have been met. This involved in the nonconformity, for
should be carried out at appropriate stages of example, what service time interval,
the service realization process in accordance service machines or
with the planned arrangements (see clause services are involved;
7.1). Evidence of conformity with the
acceptance criteria should be maintained. b) to identify the nonconforming
product to make sure that it can be
Records should indicate the person(s) distinguished from the conforming
authorizing release of service for delivery to product (see clause7.5.3);
the customer (see clause 4.2.4).
c) to document the existence and
The release of service and delivery of service source of the nonconformity;
to the customer should not proceed until
the planned arrangements (see clause 7.1) d) to evaluate the nature of the
have been satisfactorily completed, unless nonconformity;
otherwise approved by a relevant authority
and, where applicable, by the customer. e) to consider the alternatives for the
disposition of the nonconforming
product;
f) to decide upon and record what

disposition should be made;
53
g) to control the subsequent of the product or the replacement of

processing of the nonconforming certain product), or
product consistent with the
disposition decision; d) in extreme cases, requesting the
physical return or destruction of
h) to notify others who may be affected product.
by the nonconformity including, if
appropriate, the customer and/or Information concerning nonconforming
consumers. product should be provided to all appropriate
personnel, so that action is taken, if
When a nonconformity is determined, the necessary.
NMRAs should take steps to investigate and
eliminate the reason for the occurrence of the 8.4 Analysis of data
nonconformity (Corrective Action) as well as
determine what do to with (disposition of) the Data should be collected and analysed in
nonconforming product. If the nonconforming order to verify the ongoing suitability and
service is to be used, accepted or released, effectiveness of the quality management
the NMRAs should decide to do so either by system and to determine if there are any
correcting the nonconforming product and trends or patterns which require attention.
then re-evaluating it or by using the service Negative trends should be considered for
as is. improvement. The results of the analysis
of data should be an input to management
“Correction” refers to repair, rework, or review.
adjustment and relates to the disposition
of an existing nonconformity; whereas the Analysis of data can help to determine the
“Corrective Action” relates to the elimination of root cause of existing or potential problems,
the root causes of nonconformity (see clause and thereby to guide decisions about the
8.5.2). corrective and preventive actions needed
for improvement. For an evaluation of the
The procedures for dealing with non- effectiveness of the quality management
conformities discovered in product/service system, data and information from all parts
which has already been issued market of the NMRAs should be integrated and
authorization can include taking such analysed.
actions as:
The results of this analysis can be used by the
a) withdrawing product from sale, NMRAs to determine:
b) withdrawing product from a) trends in service conformance,

distribution,
b) extent to which customer
c) giving advice to customers (this requirements are being met,
can take the form of checks to be
carried out before use, providing c) process effectiveness,
additional guidance on the use
54
d) supplier performance, and e) implementing the selected solution;
e) success of performance f) measuring, verifying, analysing and

improvement objectives. evaluating results of the
implementation to determine that
the objectives have been met; and
The analysis of data should provide
information relating to: g) formalizing changes.
a) customer satisfaction surveys, Results are reviewed, as necessary,

to determine further opportunities for
b) conformity to client charter improvement. In this way, improvement is a
requirements continual activity.
c) key performance indicators for all 8.5.2 Corrective action

functional activities of the NMRA
Corrective action is action to eliminate the
d) market complaints and product root cause of a detected nonconformity or
recalls other undesirable situation. If nonconforming
service is involved, this is handled according
8.5 Improvement to clause 8.3 of EAC QMS Requirements
and the action taken to prevent recurrence of
8.5.1 Continual improvement the nonconforming service is handled under
clause 8.5.2 of EAC QMS Requirements.
The NMRA should continually improve the
effectiveness of the quality management The NMRA should have a documented
system through the use of the quality policy, procedure for corrective action which
quality objectives, audit results, analysis of clearly establishes responsibility for taking
data, corrective and preventive actions and corrective action, when and how this action
management review. will be carried out, and verification of the
effectiveness of the corrective action.
Actions for improvement include the following:
An important element in the program is the
a) analysing and evaluating the dissemination of quality problem information to
existing situation to identify areas those directly responsible for ensuring quality.
for improvement; Causes of detected nonconformities should
promptly be identified so that corrective action
b) establishing the objectives for can be taken and recurrence prevented.
improvement;
These causes can include the following:
c) searching for possible solutions to
achieve the objectives; a) failures, malfunctions or
nonconformities in processes, tools,
d) evaluating these solutions and equipment or facilities in which
making a selection; services are handled,
55
b) inadequate or non-existent k) solicited information on new or

procedures and documentation, modified services,
c) non-compliance with procedures, l) published literature, and
d) inadequate process control, m) published reports of failures of

similar services.
e) poor scheduling,
Key features of the documented procedure(s)
f) lack of training, necessary to effectively implement corrective
action may include
g) inadequate working conditions,
a) clear and accurate identification of
h) inadequate resources (human or the nonconformity,
material), and
b) details of the investigation
i) inherent process variability. conducted including consideration
of what other service(s), process(e)
Input to corrective action can come from many or procedure(s) might have been
sources, including the following affected,
a) inspection and test records, c) identification of the root cause of the

nonconformity,
b) validation study results,
d) identification of the action required
c) nonconformity records, to prevent recurrence of the
problem,
e) any necessary approvals required
d) observations during process before any action is taken,
monitoring,
f) a record that the identified corrective
e) audit observations, action was taken,
f) field, service or custo g) a check that the corrective action

mer complaints, taken was effective (in other words
verification that the non-
g) customer observations, conformance is unlikely to recur).
h) observations and reports by The extent of corrective action taken should

personnel, be dependent upon and related to the risk,
i) supplier problems, size and nature of the problem and its effect(s)
on service quality.
j) management review results,
56
For example, the level of investigation to e) customer feedback,

determine the cause of the nonconformity,
the work done to determine and verify the f) process measurements,
appropriateness of corrective action, and the
level of documentation kept, would be far g) statistical process control
more extensive for a nonconformity relating documents,
to the service compared to a less serious
nonconformity such as the failure to conduct h) difficulties with suppliers (see clause
an internal audit when scheduled. NMRA 7.4.1),
should implement corrective action promptly.
i) service reports.
8.5.3 Preventive action
BIBLIOGRAPHY
“Preventive action” is action to eliminate the
cause of a potential nonconformity or other EAC Quality Management System
undesirable potential situation. It is taken Requirements, 2014
when a potential nonconformity is identified as
the result of an analysis of records and other ISO 9001:2008 ( E). - Quality Management
relevant sources of information. System - Requirements
The extent of preventive action taken should ISO/IEC 17020: 2012 Conformity assessment
be dependent upon and related to the risk, - Requirements for the operation of various
size and nature of the problem and its effect(s) types of bodies performing inspection.
on service quality. Sources for information for
initiating preventive actions include: ISO/IEC 17025: 2005 - General requirements
for the competence of testing and calibration
a) evidence that previous decisions laboratories
affecting service conformity were
false, ISO/TC 210. Medical devices - Quality
management systems - Guidance on the
b) services requiring rework, application of ISO 13485:2003, AAMI (for
ANSI).
c) in-process problems, wastage
levels, PI 002_3: 2007 PIC/S- Recommendations
on Quality system requirements for
d) final inspection failures, pharmaceutical inspectorates.
REVISION HISTORY

revised of change
0 This is the
first edition.
57
PART THREE
Model Manual on the Implementation of the

EAC QMS Requirements for NMRA
58
0. INTRODUCTION This model manual will enable EAC NMRAs

to align and integrate their own quality
0.1 Background management system with the EAC QMS
Requirements.
One of the goals of East African Community
(EAC) Medicines Regulatory Harmonization 0.2. Objectives
Project is to have harmonized and functioning
Quality Management System (QMS) within The objectives of this manual are:
the EAC National Medicines Regulatory
Authorities (NMRAs) in accordance with a) To define and describe the quality
national and internationally recognized management system, authorities
standards. This document provides and responsibilities of the
requirements for implementing quality management personnel involved
management systems in EAC NMRAs. in the operation of the system, and
provide references to the general
All NMRAs in the EAC have management procedures for all activities
systems for creating and delivering their comprising the quality system
services to customers. However, some of of the entire NMRA, based on EAC
the NMRAs lack quality management QMS Requirements.
systems, a situation that leads to wasteful
processes, poor services delivery and b) To guide the employees of NMRA
unsatisfied customers. through the various requirements
of the EAC QMS requirements for
This manual acts as a model quality manual NMRAs that must be met and
for EAC NMRAs in documenting their quality maintained in order to ensure
management system as per EAC QMS customer satisfaction and continual
Requirements. It defines; improvement.
a) the scope of the quality c) To communicate the quality

management system, including management system to the
details of and justification for any customers, stakeholders,
exclusions; development partners and other
interested parties of the EAC NMRA
b) the documented procedures and to inform them of the specific
established for the quality controls that are implemented by
management system, or reference the NMRA to assure quality service
to them, and delivery to the population of the
EAC Partner State.
c) description of the interaction
between the processes of the 0.3. Scope of EAC QMS model manual
This manual documents the QMS of EAC
NMRAs in accordance with EAC QMS
Requirements.
59
QUALITY MANAGEMENT SYSTEM for Section 7 (specify the clause and

provide justification).
1. SCOPE
2. NORMATIVE REFERENCES
1.1. General
a) EAC QMS Requirements
This manual meets the requirements of “EAC
QMS Requirements 2014” andapplies to all b) EAC QMS Guidelines
activities that affect the quality of products
and services supplied by EAC NMRAs. These In addition, the following referenced
include key regulatory activities of NMRAs documents are indispensable for the
such as; Inspection, registration, control of application of the QMS:
import and export, post marketing surveillance
and quality control of medicine, cosmetics, a) ISO 9000:2005, Quality
medical devices and diagnostics. Management Systems -
Fundamentals and Vocabulary.
It also includes support functions of
NMRA such as finance and audit, quality b) ISO/IEC 17025: 2005 - General
management, procurement, information requirements for the competence of
communication technology (ICT), legal testing and calibration laboratories
services, human resource and administration,
public relation and others as applicable. c) ISO/IEC 17020: 2012 Conformity
assessment - Requirements
The QMS in this manual shall apply to all for the operation of various types of
directorates, departments, units and sections bodies performing inspection
of the NMRA at all its geographical locations
. d) PI 002_3: 2007 PIC/S -
1.2. Application of the Quality Recommendations on Quality
Management System system requirements for
pharmaceutical inspectorates EAC
All requirements of Quality management Partner states application statutory
systems for the regulation of medicines, and legal requirements
cosmetics, medical devices, and diagnostics
shall be applicable to the NMRA. e) EAC Standards, Quality,
Metrology and Testing (SQMT)
1.3. Exclusions from the EAC Act (2006) - revised 2013
QMS requirements
3. TERMS AND DEFINITIONS
a) All clauses of EAC QMS
Requirements 2014 apply and there The terms and definitions given in ISO 9000:
are no exclusions, or 2005 shall apply for purposes of this manual.
b) All clauses of EAC QMS

Requirements 2014 apply except
60
The following terms and definitions for 4. QUALITY MANAGEMENT

“product”, “customer” and “Top Management” SYSTEM
shall apply for the EAC NMRAs:
4.1. General requirements
h) Customer: organization or person
that receives a product, for example, The NMRA has:
consumer, client, end-user, retailer,
beneficiary and purchaser. a) determined processes needed for
the QMS and their applications
NOTE 1: throughout the NMRA;
A customer can be internal or external to the
organization.
b) determined sequence and
NOTE 2: interactions of these processes (see
“Regulated Customer”: Organisation or Annex 1 - NMRA processes
person who by the nature of their business are interaction);
subject to regulation by the NMRAs
c) determined criteria and methods
NOTE 3: needed to ensure that the operation
“Unregulated Customer”: Organisation or and control of the processes are
person who is not subject to regulation by effective, and has documented
NMRAs. them in manuals, guidelines,
documented procedures, work
i) “Product”: Applies to regulatory instructions, forms and other
services intended for, or required by, controlled documents;
the customer (regulated and/
or unregulated customer) and d) provided the necessary financial,
to any intended output resulting human, physical and technological
from the product realization resources and information
processes of the NMRA (e.g. necessary to achieve planned
market authorization or medicine results and continual improvement
registration certificates, licences, of these processes. Resources
permits, good manufacturing needed for the QMS have also
practice certificates, good been included in the NMRA
distribution practice certificates, approved annual budget;
medicine/drug register)
e) established key performance
j) “Top management”: person or indicators that monitor, measure and
group of people who direct and analyze these processes;
control an NMRA at the highest
level. f) instituted actions to achieve the
planned results and to ensure
continual improvement of the
processes.
61
g) established control over outsourced 4.2.3 Control of documents

processes that affect product
conformity to requirements (the The NMRA has developed a documented
NMRA should describe the procedure (state the SOP number) for the
outsourced processes). control of internal and external documents
(Refer to EAC Model procedure for control
4.2. Document requirement of documents, doc.# EAC/TF-MED/QMS/FD/
SOP/N1R0).
4.2.1 General
4.2.4 Control of records
The NMRA has established the following
documents of internal origin for the quality The NMRA has developed a documented
management system: procedure (state the SOP number) for the
control of records (Refer to EAC Model
a) quality policy; procedure for control of records, doc.# EAC/
TF-MED/QMS/FD/SOP/N2R0).
b) quality objectives;
5. Management responsibilities
c) guidelines and manuals;
5.1 Management commitment
d) standard operating procedures,
protocols and work instructions; The Top Management has been actively
involved in implementing the QMS and has
e) records and process flowcharts and provided the vision and strategic direction
for the growth of the QMS, and has also
f) forms established quality objectives and the
quality policy.
The NMRA has developed registers of
documents of internal and external origin, Top management has provided the necessary
which are updated from time to time (State human, financial, physical, technical and
document numbers of the two registers). technological resources for the successful
implementation of QMS (The NMRA should
4.2.2 Quality Manual reference documents that provide evidence
of commitment e.g. NMRA budget, staff
This is the first level of internal document in establishment, scheme of service, number of
the NMRA that describes internal functions, regional offices, hardware and software)
structure and processes with respect to QMS.
In addition of this manual, the NMRA has also 5.2 Customer focus
developed these other relevant manuals.
The top management has identified customers
(The NMRA should state the titles and with their particular needs associated with
identification numbers of other manuals that each service offered by the NMRA.
have been developed by the NMRA).
The customer needs have been determined
and translated into defined service
62
requirements (the NMRA should profile its Top management has defined and
customers and their requirements). communicated responsibilities and authorities
throughout the NMRA.
5.3 Quality policy
The current organizational structure that
The NMRA has developed a quality policy clearly shows the inter-relationship and
(NMRA should state the quality policy reporting mechanism of the personnel in the
number) which outlines its commitment to NMRA is annexed (The NMRA should annex
implementation of QMS in the entire NMRA the current organizational structure).
and ensuring customer satisfaction.
The top management of NMRA has approved
The quality policy has been formulated current job descriptions for all members
to guide the NMRA in the fulfilment of its of staff in which the responsibilities and
mission with regard to quality and customer authorities of each of the employee positions
satisfaction (Refer to EAC Model Quality on the organizational chart are defined (Refer
Policy doc.# EAC/TF-MED/QMS/FD/POL/ to NMRA job descriptions).
N1R0).
5.5.2 Management representative
5.4 Planning
The top management of NMRA has appointed
5.4.1 Quality objectives the Head of Quality Management (HQM)
(management representative) who reports
The NMRA has developed quality objectives directly to the Chief Executive Office of
(NMRA should state the quality objectives the NMRA. The HQM has the overall
document number) including those needed responsibility and mandate on matters
to meet requirements for product and has related to QMS in all NMRA sites and with
aligned with strategic objectives of NMRA. The responsibility and authority to:
quality objectives are reviewed annually for
continuing suitability. a) ensure that the requirements of the
EAC QMS Requirements are
5.4.2 Quality management system implemented and maintained,
planning
b) resolve all matters pertaining to
The NMRA has developed a strategic plan quality,
(refer to the NMRA strategic plan) to give
directions to the achievement of the mission c) report to top management on the
and implementation of QMS. performance of the Quality
Management System and any
5.5 Responsibility, authority and need for improvement, and
communication
d) liaise with certification and
5.5.1 Responsibility and authority accreditation bodies on matters
relating to the Quality Management
System.
63
The detailed duties and responsibilities of suitability, adequacy and effectiveness. An

HQM are stated in the job description (the expected outcome of these reviews is the
NMRA should state the number of the Job determination of the need for any changes to
description). the Quality Management System, including
changes to the quality policy and quality
In addition, the NMRA top management has objectives.
also appointed quality management officers as
Quality Representatives in each department. The reports and records of management
The Quality management officers functionally reviews are kept by the Head of Quality
report to the Head of Quality Management Management and are filed in accordance
Department. with Control of Records Procedure (state the
SOP number). Refer to EAC Model procedure
5.5.3 Internal communication for control of records, doc.# EAC/TF-MED/
QMS/FD/SOP/N2R0.
Internal communication in the NMRA is
through: 5.6.2 Review input
a) Internet, The input to management review includes

information on the following;
b) Intranet,
a) result of internal and external audits,
c) Letters,
b) customer feedback,
d) memos,
c) processes performance and product
e) top management, departmental and conformity ,
general staff meetings,
d) status of preventive and corrective
f) management reviews, actions (Corrective Action Request
response time),
g) appraisal and audit meetings,
e) follow-up actions from previous
h) information bulletins, Management Review,
i) newsletters, f) strategic or operational changes that

could affect the Quality
j) circulars. Management System,
5.6 Management review g) recommendations for improvement,

and
5.6.1 General
h) effectiveness of the training
Top management reviews the Quality activities for staff of theNMRA.
Management System on an annually basis
for all sites in order to ensure its continuing
64
5.6.3 Review output The employees of the NMRA are competent

through education, skill, training and
The output from the management review experience as necessary. Requirements for
includes decisions and actions related to the education, skills, training and experience are
following: documented in the job descriptions maintained
by the Human Resources department.
a) improvement of the effectiveness
of the quality management system 6.2.2 Competence, training
and its processes, and awareness
b) improvement of product related to The NMRA has:

customer requirements, and
a) determined the necessary
c) resource needs competence for personnel
performing work affecting conformity
6. Resource management to product requirements (refer to
scheme of service, and job
6.1 Provision of resources specifications and competence
matrix),
The Top Management ensures that adequate
staff, equipment and materials are available in b) identified the training needs for
order to:
the employees (refer to the training
a) implement, maintain and improve needs assessment report),
the Quality Management System
processes, c) developed a training plan which is
reviewed and updated at least once
b) ensure customer satisfaction, and a year.
c) meet the quality objectives. d) a procedure for training employees

(state the number of the SOP), and
(The NMRA should reference documents
that provide evidence of resources that have e) developed key performance
been provided e.g. NMRA annual budget, staff indicators to evaluate the
establishment, scheme of service, number of effectiveness of the trainings.
regional offices, asset register, etc..)
Training records, including evidence of
6.2 Human resources certification as applicable are maintained by
the Human Resources Department.
6.2.1 General
6.2.3 Impartiality and independence
The top management continuously ensures
that the NMRA has adequate workforce that is Top Management has adopted a code of
trained, motivated, facilitated and empowered conduct for all employees of NMRA, which
to achieve results. is in line with national public service code of
65
conduct and professional bodies (indicate Physical parameters like lighting, temperature
document title and the year). Each employee and noise are controlled. Employees are also
has signed legally enforceable commitments motivated through several reward systems.
necessary for impartiality and objectivity.
7.0 Product realization
(Refer to EAC Model Guidelines for
Declaration of Conflict of Interest, doc.# EAC/ 7.1 Planning of product realization
TF-MED/QMS/FD/GDL/N2R0).
The NMRA has:
6.2.4 Confidentiality
a) established quality objectives,
The members of the Board, advisory
committees and staff of the NMRA have b) determined product characteristics
signed legally enforceable commitments, and processes,
which are in line with national public service
code of conduct and professional bodies c) acquired inspection and test
(indicate document title and the year) for the equipment, fixtures, appropriate
management of all information obtained or storage and transportation facilities,
created during the performance of their duties.
d) The established support
(Refer to EAC Model Oath of Secrecy doc.# departments,
EAC/TF-MED/QMS/FD/FOM/N1R0).
e) established quality assurance
6.3 Infrastructure measures at different stages of
service provision (for example,
The NMRA has provided adequate offices at first and second assessors for the
the headquarters, regional offices and ports of product evaluation of dossiers, peer
entry into the country. These offices have been review of assessment reports and
provided with the necessary utilities, process peer review of GMP reports),and
equipment (both hardware and software),
and supporting services (such as transport,
communication or information systems). f) established applicable standards,
regulatory requirements and forms
The infrastructure is continually maintained to to be used for the service provision.
achieve conformity to product requirements
7.2 Customer related processes
6.4 Work environment
7.2.1 Determination of requirements
The NMRA has provided adequate and related to the product
conducive work environment in all its offices
needed to achieve conformity to product
requirements. Requirements specified by the customer
have been determined through consultative
meetings with customers (e.g. manufactures,
importers, exporters, wholesalers and
66
retail operators, practitioners, consumers 7.2.5 Complaints and appeal process

organizations), and feedback mechanisms.
To meet the product requirements, the NMRA The NMRA has established a documented
has also considered national, regional and procedure (state the document number) for
international laws and regulations. handling and resolution market complaints
and appeals from customer that includes the
7.2.2 Review of requirements related to complaints and appeals process.
the product
7.3 Design and Development
The NMRA reviews requirements related
to service provided through technical 7.3.1 Design and Development
committees. The respective directorates Planning
maintain records of these reviews.
All the processes required for service
7.2.3 Customer communication provision have been identified and assigned
to the appropriate functional departments by
The channels used for communication with Top Management. The processes have been
the stakeholders, importers, manufacturers, identified and re-engineered. Process owners,
distributors, retail and wholesalers of the process implementers and support staff have
pharmaceutical products and the general been identified and trained. The re-engineered
public include: guidelines, circulars, letters, processes have been tested, verified and
email, bulletins, annual reports, and brochures validated.
that are posted on the NMRA website or
delivered by hand, post or courier. 7.3.2 Design and Development Inputs
The print and electronic media, customer All NMRA processes have been re-engineered
care desk and stakeholders meetings are and rationalized by using management review
also used. Communication with the above results, customer feedback reports. Design
customers is also through: suggestion boxes, inputs have been identified for each process.
customer satisfaction surveys and complaint
handling system. 7.3.3. Design and Development Outputs
7.2.4 Complaints and appeals Design outputs have been identified for each
process. Information on materials, equipment,
The NMRA has established a documented competencies of personnel, process steps,
procedure (state the document number) forms and templates of reports, checklists and
for investigation and handling of market mode of services delivery to ensure conformity
complaints and appeals from customer. of the product have been developed.
(Refer to EAC Model procedure for Handling
Customer Complaints and Appeals doc.# 7.3.4 Design and Development Review
EAC/TF-MED/QMS/FD/SOP/N5R0).
Departmental team reviews, top management
review, stakeholder consultations, and Board
approval of the designs and development of
processes are carried out according to plan.
67
Records of design reviews are maintained as Controlled documents, which include

quality records are kept. drawings, test procedures, etc., are reviewed
and approved prior to their initial release or
7.3.5 Design and Development revision in accordance with the documented
Verification procedure for document control (state the
SOP number).
The NMRA has a schedule for the verification
of the design and development of its (Refer to EAC Model procedure for control
processes. Every process is assessed to of documents, doc.# EAC/TF-MED/QMS/FD/
verify whether the design and development SOP/N1R0).
outputs meet the design and development
input requirements. Records of the results of 7.4 Purchasing
the verification are maintained.
7.3.6 Design and Development
Validation Procurements in NMRA are governed by
national laws (e.g. Public Procurement and
Service provision and performance are Disposal of Public Assets Act).
validated in service provision specification.
These activities typically include piloting to Pursuant to the Act, the NMRA has a
targeted customers under defined operating procedure for purchasing (state the document
conditions to determine reliability and number) that describes the criteria for
consistency, and assessment of customer selection, evaluation and re-evaluationof
perception of the service provision. Records of suppliers, and award of tenders.
the results of validation are maintained.
Records arising out of the procurement
At the completion of design and development process including evaluation of suppliers are
validation, the NMRA ensures that reports, maintained by the Procurement Department.
calculations, test results, piloting results, etc.,
demonstrate that the service provision meets 7.4.2 Purchasing information
the specification requirements for all identified
operational conditions. The NMRA develops and maintains
purchasing information describing the product
7.3.7 Control of Design and to be purchased. This information includes
Development Changes product specifications, procedures and
acceptance criteria.
Design changes can result in a change to
existing documentation or the generation 7.4.3 Verification of purchased product
of new documentation. Design change
documentation is reviewed, approved, The NMRA ensures that purchased
controlled, recorded and issued in accordance products are inspected and verified against
with established change control procedure the purchase information before they are
(state the SOP number) by the same functions accepted.
involved in the original issue.
68
Goods Receipt Notes are kept as evidence of 7.5.4 Customer property

inspection and verification of the purchased
product. The NMRA identifies, verifies, protects and
safeguards customer property provided for
7.5 Production and service provision use during services realization while it is under
the NMRAs control.
7.5.1 Control of production and
service provision Customer property include Marketing
authorization product dossiers and samples,
The NMRA carries out service provision under site master files for pharmaceutical
controlled conditions using written procedures, manufacturing facilities, proforma invoices,
work instructions, checklists and qualified medicine samples taken for QC testing
equipment. Additional controls include purposes, confiscated medicine, medicine
assessment and checking at different levels promotional materials, certificates, intellectual
property and personal data , other information
before final released or approval of the service and any other documentation supplied by the
by the relevant authority. customer.
7.5.2 Validation of processes for Where customer property is lost, damaged

production and service provision or otherwise found to be unsuitable for use,
the NMRA carries out an investigation to
Processes for service provision are validated establish the root cause and reports this to the
to ensure that they achieve the plan results. customer.
Validation protocols that define criteria
for review and approval of the processes, Records showing the results of the
qualification of personnel are developed. investigations carried out and the corrective
actions taken are maintained.
Records of validation of service provision are
maintained 7.5.5 Preservation of the product
7.5.3 Identification and traceability The NMRA preserves the conformity of

product during internal processing and
The NMRA identifies different regulatory delivery to the intended destination. This
product by allocating unique product preservation includes identification, handling,
identification numbers (e.g. Marketing storage and protection. Preservation of
Authorization Number, Permit number, License product includes, where applicable in
Number, GMP certificate number, Adverse accordance with product specifications and/or
Event Report Number, Poor quality Medicine applicable regulations, provisions for:
Report Number, etc.)
a) cleaning,
Records (registers) showing the identification
numbers of regulatory products are b) prevention from contamination and
maintained. deterioration,
69
c) marking and labelling including monitoring and measurement techniques,

safety warnings, including statistical techniques.
d) shelf life, and Implementation occurs according to the

defined plans, the resulting data is analysed
e) special handling and storage for and improvements are pursued.
temperature-sensitive materials and
products. 8.2 Monitoring and measurement
Secure storage facilities are provided as 8.2.1 Customer satisfaction

necessary for storage of material and products
pending use or dispatch, to prevent damage The success in meeting customer’s
or deterioration. (The NMRA to provide requirements and in achieving a high level of
information on handling and storage facilities customer satisfaction with the NMRA products
and their locations). and services is evaluated on a regular basis.
This is done using:
7.6. Control of monitoring and
measuring equipment a) in-service performance monitoring,
The monitoring and measurement equipment b) customer complaint analysis, and

are controlled and maintained so as to ensure
validity of the monitoring and measurement c) regular customer satisfaction
results. Where measuring devices are used surveys, at least once a year.
the NMRA has established processes to
ensure that monitoring and measurement can The results are presented to top management
be carried out in a manner that is consistent during the annual management review
with the monitoring and measurement meetings.
requirements by establishing calibration
procedures. An efficient method of handling customer
inquiries is established to provide a rapid
Records of calibration of the measuring response to NMRA customers who have an
equipment are maintained by the respective urgent need for assistance or a complaint,
directorate. which would adversely affect customer
satisfaction (e.g. hotline, SMS services, NMRA
8.0 Measurement, analysis and website, social networks, etc.)
improvement
8.2.2 Internal audit
8.1 General
The internal audits are conducted according
The NMRA has put in place systems to to an established schedule. An audit plan is
monitor, measure, analyse and improve maintained to ensure that all aspects of the
processes for the QMS. Quality System are properly addressed. The
frequency and scope of the audits take into
NMRA product quality plans are used consideration the significance of the process
for planning and defining the necessary and results of previous audits.
70
A documented procedure for conducting These are detailed below:-

internal quality audit (state the SOP
number) has been established to define the a) Internal Monitoring and Evaluation
responsibilities and requirements for planning
and conducting audits, establishing records i. Regular departmental and Senior
and reporting results. Management meetings,
(Refer to EAC Model procedure for ii. Quarterly, semi-annual and annual
Conducting Internal Quality Audit, doc.# EAC/ performance review meetings,
iii. Internal audits,
The results of the audits are recorded
and submitted to the personnel having iv. Customer feedback,
responsibility in the area audited. The audit
is complete when the implementation and v. Annual management review
effectiveness of corrective actions has been meetings,
verified and recorded. Audit results become
part of the quality records and are presented vi. Annual self-assessment using the
at management review. WHO Assessment tool (WHO \
Data Collection Tool for the Review
8.2.3 Monitoring and measurement of Drug Regulatory Systems)
of processes
vii. Mid-term review of the NMRA
NMRA has established the monitoring and processes.
measurement process to be applied to the
realization processes necessary to achieve b) Sectoral Monitoring and Evaluation
customer requirements such as Internal Audit
and Statistical Techniques. The resulting i. Quarterly, bi-annual and annual
information is reported to top management to reports to Ministry responsible for
assist in decision making process. Health and any other relevant
government institution
Performance indicators have been established
for everyNMRA processes and are periodically ii. Review of NMRA’s performance
analysed to determine whether the set targets during the Annual Joint Review
for the key results areas have been achieved. Mission and the National Health
If the planned results are not achieved, Assembly (Partners review).
correction and corrective action are taken to
ensure the product conformity. c) External Monitoring and Evaluation
Three approaches will be used for monitoring i. External audits ( e.g. ISO 9001
and evaluation in assessing the NMRA certification)
performance with respect to the processes
namely; self-reviews (internal), supervisory ii. Statutory audits (e.g. from auditor
body reviews (sectoral) and peer reviews general)
(external).
71
iii. Other audits of this manual. Non-conformances during

in-process inspection and test are handled in
d) WHO Assessment as appropriate. accordance with clause 8.3
In the event of process nonconformity, The NMRA keep records that indicate the
appropriate actions are taken to eliminate person(s) authorizing release of product
the cause of the nonconforming process and for delivery to the customer. The release
evaluate whether the process nonconformity of product and delivery of service to the
has resulted in product nonconformity. If customer does not proceed until the
product nonconformity has resulted this planned arrangement has been satisfactorily
product is identified and controlled according completed, unless otherwise approved by a
to documented procedures (State the SOP relevant authority and, where applicable, by
number). the customer.
(Refer to EAC Model procedure for Control of 8.3 Control of non-conforming

Non-Conforming Product doc.# EAC/TF-MED/ product
QMS/FD/SOP).
Control of Nonconforming Product procedure,
8.2.4 Monitoring and measurement (State the SOP number) defines the
of services responsibilities, authorities and methods used
for the identification, segregation, review
The NMRA monitors the characteristics of the and disposition of nonconforming products,
services to verify that services requirements as well as the implementation of corrective
have been met. action in order to prevent recurrence of the
nonconformity.
Records indicating the officer(s) authorizing
release of services for delivery to the customer (Refer to EAC Model procedure for Control
are maintained. of Non-Conforming Product doc. # EAC/TF-
MED/QMS/FD/SOP/N4R0).
Key characteristics of the services have
been identified, monitored and controlled Records, clearly identifying the product,
at appropriate stages of service provision the nature and extent of nonconformity, the
process in accordance with planned approved disposition and corrective action
arrangements and evidence of conformity taken are maintained and form part of the
with acceptance criteria is maintained. quality records.
Products are withheld from further processing Parties requiring notification of nonconforming
until there is objective evidence that the product may include suppliers, internal
required inspection and test have been organizations, customers, distributors, and
performed. relevant government agencies.
The in-process inspection and test may be 8.4 Analysis of data

reduced or eliminated with the implementation
of proven statistical process control NMRA quality management system data
techniques, in accordance with clause 8.4 is recorded and analysed to determine the
72
suitability, effectiveness and opportunities data, corrective and preventive actions and
for improvement of the quality management management review.
system. The data analysis objectives for
NMRA are: The NMRA’s continual improvement is:
a) To assess customer satisfaction a) A part of the quality policy

levels or to reveal customer
dissatisfaction b) Reflected in the quality objectives
b) To determine success rates in c) A part of the actions taken upon

fulfilling customer requirements audit results
d) Driven by opportunities surfacing

c) To gather knowledge on trends from data analysis
associated with product and
processes e) A result of corrective action
d) To maintain awareness of the f) A result of preventive action

performance of suppliers.
g) A required output from management
The NMRA analyse the following data to review
demonstrate the suitability and effectiveness
of the QMS and to evaluate where continual 8.5.2 Corrective action
improvement of the QMS can be made;
The NRMA carries out corrective actions in
e) Internal and external audits reports accordance with the documented procedures
(state SOP number). The needs for corrective
f) Customer satisfaction surveys action are documented on a Corrective Action
reports Request (CAR) and submitted to the process
owner or the supplier, for the identification
g) Key performance indicators for all of the root cause and to initiate appropriate
functional activities of the NMRA corrective action. The CARs are entered in a
h) Market complaints and product central database for tracking and follow-up.
recalls The originator ensures that the corrective
i) supplier/contractor performance action is implemented in a timely manner and
reports; is effective before closing the CAR. Corrective
action requests that are not closed are
8.5 Improvement discussed at the management reviews.
8.5.1 Continual improvement (Refer to EAC Model procedure for handling

Corrective and Preventive Action doc. # EAC/
The NMRA continually improves the TF-MED/QMS/FD/SOP/N7R0).
effectiveness of the quality management
system through the use of the quality policy,
quality objectives, audit results, analysis of
73
The NMRA takes action to eliminate the root Records of results taken are maintained by
causes of nonconformities in order to prevent the respective directorates.
recurrence.
Non-conformities are analysed to determine
Records of corrective action taken are the preventive actions needed to avoid
maintained by the respective departments their occurrence. The analysis may include
the review of the dispositions taken on
8.5.3 Preventive action nonconforming products, observations
during internal and customer audits, trends
The NMRA determines action to eliminate the in rejection reports and product returns, and
causes of potential nonconformities in order customer complaints.
to prevent their occurrence. A documented
procedure for preventive action (state the The depth of the analysis is related to the
SOP number) has been established to criticality of the nonconformity, the impact on
define requirements for determining potential performance, reliability, customer satisfaction,
nonconformities and their causes, evaluating safety and the risk involved. Relevant
the need for action to prevent occurrence information on preventive actions taken is
of nonconformities, determining and submitted for management review.
implementing action needed, and reviewing
the effectiveness of the preventive action
taken.
(Refer to EAC Model procedure for handling

Corrective and Preventive Action doc. # EAC/
REVISION HISTORY

revised of change
0 This is the
first edition.
74
Annex 1- Model Process interaction diagram:

A. High Level Process Interaction
75
B. Low Level Process Interaction
76
Annex 2: Model Quality Policy.
It is the policy of East African Community National Medicines Regulatory Authorities (NMRAs)
to ensure safe, quality and efficacious pharmaceuticals and related technologies that satisfy
customers while meeting statutory and regulatory requirements.
NMRAs are committed to continually improving the effectiveness of the QMS through customer
focus, teamwork; and provision of adequate financial, human, physical and technological
resources.
To ensure customer and statutory requirements are met, top management establishes Quality
objectives at relevant functional levels.
This quality policy and objectives shall be communicated to all NMRA staff and shall be reviewed
periodically for continuing suitability.
77
Annex 3 Medicine Regulations mapping processes

1. Data Flow Diagram for GMP Inspection Conduction process
78
2. Diagram for Preparation and Planning for GMP inspection
79
3. Diagram for New Human Medicine Registration process
80
4. Diagram for Post Marketing Surveillance process
81
5. Diagram for Payment Process
82
6. Diagram for Human Medicine Query response Process
83
7. Diagram for Rejection Appeal on Human Medicine process
84
6. Diagram for Human Medicine Query response Process
85
PART FOUR
EAC QMS Model Standard Procedures
86
1. Purpose sponsibility to ensure all staff are

aware of the SOPs and their indi
To describe the process for development, vidual responsibilities are defined
approval, use, updating, archiving and within the SOPs.
disposal of documents within the EAC
NMRAs. 3.3 All members of staff who have any
involvement or responsibilities
2. Scope outlined in the SOP must ensure
they have read the SOP and are
The SOP applies to: fully aware of their responsibilities in
the procedure.
2.1. All controlled internal documents for
all NMRAs 4. Distribution List
2.2. All controlled external documents 4.1 Head NMRA

used in all NMRAs
4.2 Directors
3. Responsibility
4.3 Head/Managers (Departments/
3.1 The NMRA's management team is Sections/Division)
responsible for the development of
template SOPs to support each 4.4. Head Quality Management
process of NMRA.
3.2 The template SOPs must then be

completed and implemented by
Heads of Departments/Unit in all
departments/units. It is their re
87
5. Language top corner and its revision level

below the form number as per
All documents must be written in either Addendum 3. (This is optional but
English or any other language depending on en-sures consistency)
the area of application and level of fluency of
intended users. 7.1.7 Each department shall keep and
maintain a list of departmental
6. Materials and Equipment documents as prescribed in
Addendum 7.
Document identification stamps:
7.1.8 HQM shall keep and maintain a list
a) “ORIGINAL COPY” of EAC NMRAS documents as
b) “CONTROLLED COPY” prescribed in Addendum 7.
c) “UNCONTROLLED COPY”
d) “OBSOLETE DOCUMENT”, 7.1.9 All documents must be numbered in
the following numbering system:
7. Procedure NMRAS/Directorate/Department/
Document/Serial Number (e.g.
7.1 General NMRAS/DMC/DMI&E/Doc/xxx for
documents generated by
7.1.1 Drafting of documents must be department of medicine and
initiated by user departments. cosmetics inspection and
enforcement under the Directorate
7.1.2 All documents must be edited at of medicine and cosmetics), where
relevant levels before publication. xxx is the serial number.(Numbering
may differ from one NMRA to
7.1.3 All obsolete documents must be another)
destroyed by shredding/tearing/
burning. 7.1.10 Internal documents shall be denoted
by three letters (YYY): e.g.Chart-
7.1.4 Unless specified otherwise, CHT, Form-FOM, Job Description-
all documents must be written using JBD and Protocol-PTC
Bookman Old Style, font 11. (The
font type and size may vary from 7.1.11 All power-point presentations must
one NMRA to another) be made on template slides as
prescribed in Addendum 1.
7.1.5 Unless specified otherwise,
all documents must be in white, A4 7.1.12 Documents of external origin shall
paper size and printed with black be received at the registry and
ink. stamped “Received’ and sent to
library prior to distribution in
7.1.6 Quality forms shall bear accordance to relevant library
NMRAS log at the left top corner, procedures.
title of the form at the centre, form
number in italic format at the right
88
7.2 SOPs a) 10 pt bold for title with capital letters

b) 11 pt bold for major headings
7.2.1 Preparation of SOPs c) 11 pt for text
d) 8 pt for headers and footers
7.2.1.1 SOPs must be written in a format as
prescribed in Addendum. 7.2.3 Numbering of SOPs
7.2.1.2 SOPs developed for use within 7.2.3.1 SOPs must be assigned code
Directorates shall be initiated by numbers on the header provided on
Department Managers or any other every page of the SOP.
person within the NMRA as
appropriate a Manager will allocate 7.2.3.2 SOP numbers must be in the format
one of the future users to prepare it. MRAS/Directorate/Department/
SOP/xxx, where xxx is the serial
7.2.1.3 SOPs developed for use between number.
Directorates must be prepared by
respective Director, checked by 7.2.3.3 The SOP number must not be
HQM and authorized by Head changed even if the version has
NMRA (HNMRA). been changed.
7.2.1.4 Draft SOPs must be circulated 7.2.4 Signing of SOPs

within the Department for comments
before approval. 7.2.4.1 SOPs must be signed by persons
indicated in the header as
7.2.1.5 SOPs must be checked by HQM prescribed in Addendum 2.
before being authorized by
respective Directors and/or HNMRA. 7.2.4.2 SOPs must bear approved
designations and signatures and
7.2.1.6 SOPs generated by HQM must be therefore considered as original
prepared by Quality officer, checked copy.
by HQM and authorized by HNMRA.
7.2.4.3 SOPs without three signatures will
7.2.1.7 The effective date should be be considered invalid.
indicated by the respective manager
after a period of time whereby the 7.2.5 Issuance of SOPs
SOP have been approved, trained
and understood by the users 7.2.5.1 Original SOPs shall bear
a red ink stamp with the words
7.2.2 Fonts and font size “Original Copy”
7.2.2.1 SOPs must be written 7.2.5.2 Copies of the original SOPs shall
using Bookman Old Style as bear a blue ink stamp with the
follows: (font type and size may vary words “Controlled Copy” and should
from one NMRA to another) indicate a copy number.
89
7.2.5.3 Copies to be issued to external original information; where

customers shall bear a black ink appropriate the reason for the
stamp with the words “Uncontrolled alteration should be recorded.
Copy”
7.2.6.8 Head Quality Management shall
7.2.5.4 SOPs will be issued to users by maintain a history of revisions and a
HQM and records maintained in file of superseded documents.
the “Master Distribution List of
EAC NMRAS Documents” 7.3 Minutes
prescribed under Addendum 4.
7.3.1 Numbering of minutes
7.2.5.5 Unauthorized SOPs must not
be circulated. 7.3.1.1. Minutes of Management meetings
shall be numbered in the following
7.2.6 Review and validity of SOPs numbering system: NMRAS/
HNMRA’s Office /Type & # of
7.2.6.1 SOPs must be reviewed after two meeting/financial year e.g.
years of use as indicated in the NMRAS/HNMRA/MN.1/2011/12 for
header. the first Management meeting
held in 2011/12 where HNMRA’s
7.2.6.2 Reviews must be initiated within Office is responsible for co-
user Department, following ordination. (This may vary from one
procedures described under 7.2.1.2 NMRA to another)
7.2.6.3 For major SOP changes such as 7.3.1.2 Minutes of directorate/department

changes in procedures and respon meetings shall be numbered in
sibilities, a new version of the SOP the following numbering system:
must be written. NMRAS/Directorate/Type & # of
meeting/financial year e.g.
7.2.6.5 SOPs shall bear a revision NMRAS/DBS/MT.1/2011/12 for the
history page in a table on a last first monthly meeting held in 2007
page and shall bear revision where DBS is responsible for
number, date, Author (responsible co-ordination.
person), section modified, a
description of change and 7.3.1.3 Minutes of Board of Directors (BOD)
approvals. See Addendum 8 meetings shall be numbered in the
following numbering system: EAC
7.2.6.6 For minor changes such as editorial NMRAS/HNMRA’s Office /Type
corrections and layout these should & # of meeting/tenure of office e.g.
be noted by the user and NMRAS/HNMRA/BoD.1/2010-14
considered during the next review. the first BOD meeting held within
the period of 2010-2014 where
7.2.6.7 Any minor changes made should HNMRA’s office is responsible for
be signed and dated; the alteration co-ordination.
should permit the reading of the
90
7.3.1.4. For extra ordinary meetings 7.4.4 The main contents of guidelines,
numbering will be the same except manuals and policies must be as
“Type & # of meeting” shall be shown in Addendum 6.
replaced by “Ex-MN. 1” for
Management meetings, “Ex-MT. 7.4.5 Guidelines, manuals and policies
1” for Board of Directors meetings must be numbered in the format
and “Ex-BOD.1” for BOD meetings. NMRAS/Directorate/Department/
Guideline, Manual or Policy/xxx,
7.3.1.5. Various committees shall follow the where xxx is the serial number (e.g.
same numbering system as NMRAS/DLS/TS/G or M or P/002).
prescribed in 6.1.5
7.4.6 The number must be bolded, itali
7.3.1.6 Numbering in between the texts cized and positioned on top and far
shall be as follows: right of the title page.
a) 1.0, 2.0, etc for major headings. 7.4.7 The full address of the Authority
must be printed at the bottom of the
b) 1.1, 1.2, 1.2.1 etc for sub headings title page (Addendum 5).
followed by a, b, c… and i, ii, iii(The
numbering may differ so long as 7.4.8 Copyright remarks must be shown
there is consistency) at the bottom of the back page of
manuals and/or policies
7.3.1.7 Bullets must not be used for (Addendum 5).
numbering items of minutes, SOPs
and any other documents. 7.4.9 The name of the document must be
written on the header of every
7.4 Guidelines, Manuals and policies page (except title page) and page
numbers formatted at the centre of
7.4.1 Draft guidelines, manuals and the page.
policies shall be prepared by
user directorate, reviewed by 7.4.10 The date of approval of the docu
relevant Technical Committee ment must be indicated at the bot
or a special committee formed for tom of the front page.
that particular purpose, checked by
HQM and approved by HNMRA. 7.4.11 The revision of guidelines, manuals,
and policies are subject to the same
7.4.2 All draft guidelines, manuals and review and approval process of the
policies intended to be used by original document.
customers shall be presented to
relevant stakeholders for their 7.4.12 The guidelines, manuals and
feedback before approval policies shall be reviewed after
every two years or when need
7.4.3 All guidelines, manuals and policies arises.
must have a title page as shown
in Addendum 5.
91
7.4.13 The approval, review, effective date 7.4.20 Authorized MS Word documents
and revision number of the must be converted to PDF/A file
guidelines, manual and policy shall and stored in the central server
be indicated in the header as per and hard copies made available in
Addendum 2. the library.
7.4.14 The manuals, guidelines and 8.0 Records

policies shall bear a revision history
page which indicates revision num 8.0.1 The master distribution list file, and
ber, date, responsible person, general list of documents shall be
description of change. kept and maintained by HQM for a
period specified by NMRA
7.4.15 Head Quality Management shall
issue only controlled copies of the 8.1 References
quality manual to be used by EAC
NMRAS personnel. The following documents will be useful when
controlling documents of an NMRA;
7.4.16 Uncontrolled copies of the Manual,
guidelines and policies shall be a) National Laws and regulation for
distributed to external customers medicines, cosmetics, medical
and in the websites where devices and diagnostics
appropriate.
b) National Laws and regulation for
7.4.17 Manager Quality Management archiving
revises all copies of the quality
manual and distributes as required. c) The EAC QMS requirements for the
regulation of medicines, cosmetics,
7.4.18 A record of all controlled copies of medical devices and diagnostics.
the quality manual, and uncontrolled
copies of manuals, guidelines and 9.0 Definitions, acronyms and
policies issued is maintained by the Abbreviations
HQM
Definitions
7.4.19 Review of guidelines, manuals and
policies shall be initiated by user 9.1 “Author”: The Author shall be the
directorate, reviewed by relevant person(s) who created a document
Technical Committee or a special or any subsequent revision of the
committee formed for that controlled document.
particular purpose, checked by 9.2 “Authorized by”: Endorsement
HQM and approved by HNMRA. providing authority for a document
to become officially valid and to be
put into formal use.
92
9.3 “Checked by”: Endorsement 9.6 “Effective Date”: A date after the
signifying that the internal document concerned staff or persons have
is ready for authorization. been formally trained on the use of
the document and training
9.4 Controlled Document”: document records maintained, but shall not be
which is distributed to pre-deter later than 10 working days from the
mined persons or staff and if any revision date.
change or revision is made on the
document, the Head Quality 9.7 “External Document”:
Management shall submit the
revised document and make sure a) A legal, regulatory or technical
that the previous (superseded) document which is not written or
document is retrieved. created (not internally generated),
issued or revised by NMRA.
9.5 “Document”:
b) “External document” can be used
a) “Document” means readable as reference in writing internal docu
information and its supporting ments or as a manual for operating
medium. equipment.
b) A “document” describes any policy, 9.8 “Internal Document”: A document

procedure, work instruction or form which is issued and revised by the
that is to be controlled. NMRA
c) A “document” can be an Act, 9.9 “Master Document”: Original of

Regulation, standard, policy controlled internal document that
statement, manual, plan, guideline, contains original signatures of the
protocol, procedure, work authorities that approved and
instruction, drawing, specification, authorized the document.
form, record, chart, report,
certificate, checklist, aide memoir, 9.10 “Review Due Date”:
register, worksheet, textbook, A date three years from the effective
poster, notice, memorandum, date, to ensure continued adequacy
software, photograph, drawing, and suitability of a document, even
or plan. if there is no amendment to
be done.
d) A “document” may be on various
media e.g. paper, magnetic, and 9.11 “Review”: Assessment of the
electronic or optical computer disc, correctness, suitability and
and may be digital, analog, adequacy of a document including
photographic or written. technical, legal, regulatory, health,
safety, and environment compliance
issues.
93
9.12 “Reviewer”: The Reviewer shall Abbreviations and Acronyms

be the person(s) who assess a
document for technical, legal, EAC: East African Community
regulatory, health, safety, and
environment compliance issues. HNMRA: Head of National Medicines
Regulatory Authority
9.13 “Revision Date”: The date when
the document is authorized and HQM: Head Quality Management
thereby becoming officially valid.
NMRA: National Medicines Regulatory
9.14 “Revision Number”: A numerical Authority
figure that changes serially; the first QAO: Quality Assurance Officer
document shall have revision
number “0” and its first revision QMS: Quality Management System
number “1”, second revision number
“2” and so on: SOP: Standard Operating Procedure
9.15 “Uncontrolled Document”: A

document which is issued to
persons or staff who are not part
of the distribution list for that
document for information purposes
only and if any change or revision
is made on the document, the
Head Quality Management is not in
control of retrieval the previous
(superseded) document.
REVISION HISTORY

revised of change
94
Addendum 1: Format for Preparation of SOPs
1. Header
NMRAs Title: SAMPLE TITLE Revision #: Page: x of y

Logo
Validity: X Years
Doc #: Prepared by Checked by Authorised by Effective Date: Review Date:
Sign……… Sign……… Sign………

Date…....... Date…....... Date….......
2. Purpose 6.4 Where necessary other related

documents can be annexed to the
Why should the SOP be developed and used? SOP
3. Scope 6.5 A process chart should be included
The range of activities to which the document 7. Records

is applicable.
Refer to the records generated by the
4. Responsibility respective procedure
Who is involved in doing any part of the 8. References

activity?
List resources that may be useful when
5. Distribution List performing the procedure; for example,
administration policies, government standards
Who should be provided with authorized and other SOPs
copies for use
9. Definitions, Acronyms
6. Procedure and Abbreviation
6.1 Describes in detail what to do, how Identify and define frequently used terms or
to do and where to record acronyms. Provide additional and/or relevant
information needed to understand this SOP.
6.2 Procedure must be clear and under
standable 10. Revision History
6.3 It should have no or less Describe the changes made to the SOP
abbreviations
6.4 Sentences should be short and

clear containing only what is
necessary for the work to do
95
Addendum 2: Format of QMS Forms
96
Addendum 3: Master Distribution List
MASTER DISTRIBUTION LIST OF EAC NMRAS DOCUMENTS

DOC. DOCUMENT REVISION/ EFFECTIVE REVIEW ISSUED COPY DATE DATE OF SIGNATURE
NO. NAME DRAFT / APPROVAL DATE TO NO. OF RETRIEVAL
NO. DATE ISSUE
97
Addendum 4: Title and back pages for EAC NMRAS Guidelines,

Manuals & Policies
Title Page
Doc. #: EAC NMRAS/DLS/TS/G or M/002

Rev. No. 0
EAC NMRA
EAC NMRA LOGO
NAME OF DOCUMENT
Date of Approval
(Month and Year)
P. O. Box 77150, EPI Mabibo, Off Mandela Road, Dar es Salaam, Tel: +255-22-
2450512/2450751/ 2452108, Fax: +255-22-2450793,
Website: www.EAC NMRAs.or.tz,
Email: info@EAC NMRAs.or.tz
98
Back Page
All rights reserved:
This is a controlled document. It must not be copied without authorization from the Manager
Quality Management or Director of Business Support or Director General. Only originals or
authorized copies shall be used as working documents.
99
Addendum 5: Main Contents for EAC NMRAS Guidelines, Manuals

and Policies
1. Table of Contents
2. Abbreviations
3. Acknowledgements
4. Preface
5. Executive Summary, where needed
6. Legal framework/Responsibility for implementation
7. Introduction
8. Objectives
9. Scope
10. Main topics/Technical content
11. References/Bibliography
12. Authors / contributors
13. Annexes
100
Addendum 6: Master List of documents
NMRAs LOGO F02/HNMRA/QM/SOP/001Rev #: 0
S/N S/N DOC. NO. STATUS OF DOCUMENT

NAME OF REVISION/ DATE OF DATE OF
DOCUMENTS* DRAFT NO. APPROVAL REVIEW
* Documents involved include Process maps, SOPs,

Forms, Guidelines, Manuals, Plans (Strategic plan,
business plan), Regulations etc.
Addendum 8
10.0 REVISION HISTORY

revised of change
101
EAC Model Procedure for Control of Records

Doc. # EAC/TF-MED/QMS/FD/SOP/N 2R0
NMRA Title: PROCEDURE FOR CONTROL Revision #: 0 Page: 1 of 5

Logo OF RECORDS
Validity: 2 Years
Doc number Prepared by Checked by Authorized by Effective Date: Review Date:
EAC/TF-MED/ QAO HQM NMRA
QMS/FD/
SOP/N 2R0
Sign ……… Sign ……... Sign ……….. DD/MM/YY DD/MM/YY
Date: .......... Date: .......... Date: ............
1. Purpose 5.1.2 Quality records shall be identified/

coded or referenced in accordance
To describe how to identify, store, protect, to the SOPs of control of documents
retrieve, retain, and dispose records NMRAS/HNMRA/QA/SOP/001
2. Scope 5.1.3 General numbering and coding

of records shall be NMRAS/
The SOP applies to all records generated as Directorate/Department/Rec/xxx,
the result of service realization processes and where xxx is serial number.
Human resources records.
5.1.4 General files of records shall be
3. Responsibility kept at the registry and assigned file
reference numbers.
The Management Representative has overall
responsibility for the implementation of this 5.2 Storage
SOP.
5.2.1 All records of service realization
4. Distribution List shall be stored in files which shall
be kept in racks/cabinets at the
All staff electronically (protected from any registry or at the respective
alteration) Departments.
5. Procedure 5.2.2 Personnel records and training

records shall be maintained at the
5.1 Identification Human resources Department.
5.1.1 Records shall be assigned 5.2.3 Confidential human resource

identification numbers appropriate records shall be maintained at the
to the record. Head NMRA’s office.
102
5.2.4 Records shall be arranged in 5.3 Storage of closed records

cabinets alphabetically,
geographically and numerically for 5.3.1 All files of closed records shall be
easy identification and retrieval. registered in records centre transfer
form at the registry and sent to
5.2.5 All active files of records, which records centre in boxes or any other
are full, shall be closed at the means in place.
registry and transferred to records
centre. 5.3.2 The boxes shall be given a number
and the number shall be the same
5.2.6 After every three years (in as that indicated in the record
accordance to the NMRA national centre transfer.
laws) decongestion of records shall
be done at the registry and send all 5.3.3 The boxes containing records shall
inactive records to records centre. be kept at records centre office.
5.2.7 All soft copy of records shall be 5.3.4 The appraisal of records shall be
maintained in Management done after every three to five
Information System (MIS) database (according to national laws) years.
or any other system in place.
5.4 Protection
5.2.8 Records maintained in electronic
media shall be subjected to back-up 5.4.1 Records shall be maintained
and the back-up information indelibly. Any person initiating a
shall be stored in a protected and correction shall cross the wrong
secured management information information and insert the correct
system database (MIS) or any other one and then write his/her initials
system in place. and date where change was made.
The alteration should permit the
5.2.9 Only authorized personnel shall reading of the original information;
access records in hard and soft where appropriate the reason for
copy form. the alteration should be recorded.
5.2.10 The NMRA shall observe restrictions 5.4.2 The use of erasing fluid or any other
on access to information, under means of rendering information
the provisions of the law, with the illegible is forbidden.
aim to protect confidential
information, private life of a person, 5.4.3 Approved records shall not
and national security, as well as to be changed.
ensure the security of information
he/she is responsible for from 5.4.4 Records shall not be exposed to
unauthorized access, modification any agent of deterioration.
or damage.
103
5.4.5 The file movement register at each 5.7 Disposition

department shall be used to track
the files for easy traceability of 5.7.1 Outdated and/or obsolete records
the records. shall be shredded, torn and/or
burned.
5.5 Retrieval
5.7.2 Obsolete document retained for
5.5.1 Only authorized personnel shall reference purpose shall be stamped
retrieve records. obsolete.
5.5.2 All records shall be organized and 5.7.3 Computer generated records shall
stored with a record index to allow be erased from the computer media.
retrieval in a timely manner.
5.7.4 Backup information for soft copy
5.5.3 General records at the registry shall records shall be retained for
be retrieved by the registry staff reference purpose.
on request
5.8 Records Issued to customers
5.5.4 Confidential human resources
records shall be retrieved by the 5.8.1 All copies of records issued to
Personal Assistant to the Director customers shall be maintained in
General. their respective customers file at
the registry.
5.6 Retention time
5.8.2 Customers shall be informed to
5.6.1 Unless specified otherwise in the keep records issued to them
respective procedures all records protected for the whole period of
shall be retained for a period of validity of the record and then return
five years. them once they have expired.
5.6.2 Records that have permanent value

shall be kept permanently at the
records centre office.
5.6.3 Employee records shall be

maintained by human resources
Department for a period specified in
the National laws and regulation.
5.6.4 Records will be maintained in the

register as indicated in the
addendum 1
104
6.0 References 7.0 Definition, acronyms

and Abbreviation
The following documents will be useful when
controlling documents of an NMRA; “Quality Records”: information generated
from the processes described in quality
a) National Laws and regulation for system documents, and retained as indicated
medicines, cosmetics, medical in this procedure.
devices and diagnostics
The following terminologies and acronyms
b) National Laws and regulation for have been used in this document;
archiving
SOP: Standard Operating Procedure
c) The EAC QMS Requirements EAC: East African Community
for the regulation of medicines, NMRA: National Medicines Regulatory
cosmetics, medical devices Authority
and diagnostics. HNMRA: Head of National Medicines
QMS: Quality Management System
HQM: Head Quality Management
QAO: Quality Assurance Officer
REC: Records

revised of change
105
Addendum 1 - QUALITY RECORDS (This may vary from one NMRA to

another depending on the records generated by the NMRA and National rules and
regulations)
Quality Record Filed and Maintained Media Retention
(Min)
Management Reviews Quality Management Hard and Soft copy 5 years

Department
Contract Reviews (Sales Orders) Manager Procurement Hard Copy 5 years
Supplier Assessments and related Manager Procurement Hard Copy 5 years
Technical committee records Registry Hard copy 5 years
Import and Export approval of Registry and MIS database Hard and softcopy 5 years
food, medicines, cosmetics and
medical devices
Premises registration records Registry and MIS database Hard and soft copy 5 years
Disposal of food, medicines, Registry and MIS database Hard and softcopy 5 years
medical devices and cosmetics
Inspection of medicines, medical Registry and MIS database Hard and softcopy 5 years
devices and cosmetics
Medicines, cosmetics and medical Registry, Dossier room and Hard and softcopy 5 years
and devices registration MIS database
Clinical trials assessment Registry and respective Hard and softcopy 5 years
department
Nonconforming Product (NCRs) Registry Hard and soft copy 5 years
Corrective & Preventative Action Quality Department and Hard and soft copy 5 years
registry
Internal Quality Audits Registry Hard and soft copy 5 years
Training Human resources Hard copy As per the

Department National
Laws and
regulations
Quality management systems Registry Hardcopy 5 years

general correspondences files
Quality Management System Respective Directorate files Hardcopy 5 years

specific issues for Directorates
106
EAC Model procedure for Conducting Internal Quality Audit,

Doc. # EAC/TF-MED/QMS/FD/SOP/N3R0.
NMRA Title: PROCEDURE FOR Revision #: 0 Page: 1 of 15

Logo CONDUCTING INTERNAL QUALITY
AUDIT Validity: 2 Years
Document Prepared by Checked by Authorized by Effective Date: Review Date:
Number HQM HNMRA
EAC/TF-MED/
QMS/FD/SOP/
N3R0. Sign ……… Sign ……... Sign ……….. DD/MM/YY DD/MM/YY
1. Purpose b) He / she will appoint a person or

team to carry out each audit. The
a) To define how internal quality audit lead auditor will be independent of
shall be planned, scheduled, the area being audited.
organized, conducted and
documented so as to verify c) Ensuring that quality audits are
conformance to QMS requirements carried out in the NMRA
and procedures,
d) Ensuring that corrective actions
b) To verify that the QMS is effectively are closed out in a timely fashion,
implemented and maintained. within determined close-out dates
whenever possible, this is a joint
Outlined below are the procedures that will responsibility with the representative
normally be followed when conducting an of the area being audited.
audit at NMRA
e) Ensuring the records of the audit
2. Scope and their results are maintained
The procedure applies to all internal quality Auditor/audit team is responsible for:
audits carried out in the NMRA.
a) Arranging a suitable time for the
3. Responsibility audit with the representative.
Head Quality Management is responsible for: b) Reviewing the SOP and from this
developing an audit checklist.
a) Planning for and scheduling audits
covering all elements of the QMS c) Completing the audit and audit
covering both management and report.
technical aspects) to be undertaken
within a one year’s audit cycle.
107
The Auditee is responsible for cooperating audit schedule and for supporting the
with the auditor, and for providing information implementation of corrective and preventive
and resources necessary to achieve the actions as required
objectives of the audit.
4. Distribution List
The section owner of the audited organization
is responsible for taking appropriate and The distribution as per the procedure for
timely corrective action on any non-conformity control of documents.
identified during the audit.
5. Procedure
The Head of NMRA (HNMRA) is responsible
for authorizing the annual internal quality 5.1 Diagram of internal quality audit process
108
Quality audit The audit plan, when prepared, shall be

circulated to the auditee, at least five working
The HQM will select lead auditor, who has days before the audit.
had training in auditing, to conduct an audit in
specified areas of the QMS. During the audit, objective evidence shall
be collected through interview, examination
Auditors shall be selected in manner that of documents, observation of activities and
promotes independence for the activity being conditions in the area of concern.
audited. Random sampling of records, actual
witnessed activities, current document files,
The audit team is responsible for making and other related records and functions
arrangements with the appropriate auditees’ are to be reviewed against documented
representative in the area to be audited. requirements to verify compliance to the audit
criteria.
The HQM shall make audit annual plan
covering all elements of the quality In addition the audit team shall follow-up
management system of NMRA (covering both audit activities to verify and record the
management and technical aspects) to be implementation and effectiveness of corrective
undertaken at least once in a year. action taken on any Corrective Action
Requests issued.
The auditor(s) will prepare an audit checklist
based on the audit criteria. Evidence of conformity or nonconformity shall
be noted on the checklist or audit note book
The lead auditor shall review the audit criteria as appropriate.
documents and develop an audit plan which
should include, but not limited to:- Nonconformities found during the audit shall
The audit objectives, audit scope and audit be communicated (verbal or written) the
program (time table) covering all major audit same day (whenever possible) to the auditee
areas. and shall be identified and reported in terms
of specific requirements of the EAC QMS
The audit program, shall take into considered requirements.
the status and importance of the processes
and areas to be audited as well as results of All non-conformities found shall be formally
the previous audits. agreed between the Lead Auditor and the
auditee to ensure effective corrective action
Identification of personnel in areas to be of the observed condition and the adoption of
audited, depending the objective and scope of system improvements or preventive measures
the audit. to reduce or preclude the likelihood of
recurrence.
Any findings from previous audits on that
area shall be reviewed to follow up any The corrective action(s) required shall be
observations and outstanding corrective entered in the Corrective Action Request Form
actions. (enter document number) by the Lead Auditor
and submitted to the auditee,
109
The period required to clear the non- 5.3. Re- audit

conformities shall be agreed upon between
the auditor(s) and the auditee, in any case A re-audit can be organised by the HQM to
not more than three months, unless sufficient determine if the corrective actions have been
reason for longer periods have can be effective.
justified.
If the corrective actions have not been
At the conclusion of the audit, an audit report effective, it is the responsibility of the HQM
(see Internal quality audit report format in to initiate further corrective actions, and to
Annex) will be completed and shall include all inform NMRA management of any problem
findings, corrective action raised during the preventing satisfactory corrective action being
audit and corrective actions followed up from taken.
previous audits, as well as any observations
noted. These issues may be formally raised at the
NMRA management review meeting.
The audit report shall be factual, supported
by objective evidence, clear, concise, and 6. Records
understandable.
The HQM shall be responsible for the
The audit report and the corrective action maintenance of the quality audit reports and
request shall be completed by the audit team records of corrective action taken.
and submitted to auditee within one month of The audit reports, corrective action report,
the audit. checklists, audit schedules shall file in the
internal audit reports file and maintained at
The audit report shall also be distributed to the registry as per procedures of control of
top management, and to the Head Quality documents.
Management.
7. References
The auditee shall carry out corrective action
as per documented procedures for Corrective The following documents will be useful when
and Preventive Action (enter document conducting internal audits in an NMRA;
number) through root cause analysis of the National Laws and regulation, the EAC QMS
identified nonconformities and shall follow up requirements for the regulation of medicines,
the corrective action process, until the cause cosmetics, medical devices and diagnostics,
of the non-conformities is cleared. and manual on the implementation of EAC
QMS requirements
The auditee shall notify the lead auditor in
writing when he/she has confirmed that the
non-conformities have been cleared.
The lead auditor shall follow-up on the
corrective actions and closes them out within
the time frame agreed upon as per 5.2.16
above.
110
8. Definitions, acronyms
and Abbreviations
The following terminologies and acronyms

have been used in this document; This list is
not exhaustive, it could be populated as ne

EAC: East African Community
NMRA: National Medicines Regulatory
Authority
HNMRA: Head of National Medicines

revised of change
111
Annex 1
Audit Audit Non Follow Audit

date carried compliances up audit closed
planned out agreed carried by follow
out up
112
Annex 2
EAC NMRA LOGO F02/HNMRA/QM/SOP/003

Rev #: 0
INTERNAL QUALITY AUDIT CHECKLIST FORM
Directorate: Date of Audit:
Location: Name of Auditee:
Auditor: Basis of Audit:
S/N QUESTION/ AUDITOR NOTES- REFERENCE TO REMARKS

AUDIT POINT OBJECTIVE EVIDENCE REQUIREMENT (C OR NC)
ADDITIONAL COMMENTS AND SUGGESTION
113
Annex 3

Rev #: 0
ATTENDANCE REGISTER FOR INTERNAL AUDIT
OPENING/CLOSING MEETING
DATE:
S/ NAME DESIGNATION SIGNATURE

NO
114
Annex 4

Rev #: 0
AUDIT REPORT
DATE:
AUDIT REPORT NO:
1. BACKGROUND
1.1 Auditee
1.2 Auditors
1.3 Audit Criteria
1.4 Purpose of the Audit
1.5 Scope of Audit
1.6 Audit Sampling
1.7 Persons Contacted during the audit
1.8 Summary of Audit
2. FINDINGS
Clause/ Evidence Manual/ NC/OFI
Standard Procedure
3. NAMES OF LEAD AUDITOR, AUDITORS, AUDITEES AND SIGNATURES
Names and Signatures of Auditors Names and Signatures of Auditees

No. Name Date Signature No. Name Date Signature
4. RECOMMENDATION
5. CONCLUSION
115
Annex 5: Corrective action request form

Rev #: 0
CORRECTIVE ACTION REQUEST FORM
Corrective Action Request (CAR) No: Request Date:
Department / Area audited: ……………………………….Dates of Audit………………........................
Representative: …………………………………………………………………………………….…..........
Lead Auditor: ………………………………………………………………………………………………….
Auditor(s): …………………………………………………......................................................................
Assessor(s):…………………………………………..........................................................................….
Repeat problem? Yes No
If yes state CAR reference number: ……………………......................................................................
1. NON-CONFORMITY (To be completed by Auditor):
State reference to requirement in the applicable standard:
Failure in the System
Signed: ……………………………………………… (Auditor)
2. CORRECTIVE ACTION TO PREVENT RECURRENCE (To be completed by Representative

of auditee)
Date for completion of Corrective Action: ………………………………………………..........................
Signed: …………………….……………. (Representative) ..................…………………….…(Auditor)
116
Date: …………/…………/……………..
3. FOLLOW-UP AND CLOSE OUT (To be completed by Auditor):
Proposed Follow-Up Date: ……………………………………………………………………….............

Follow-Up Details:
CAR Close Out Date: ………/…………/.……… Signed: …………………..…………………..............

Auditor
Auditee’s signature………………... Date of Completion…………..…................
5. AUDITOR’S COMMENTS ON FOLLOW UP ACTION

…………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………
……………………………. …………………………… …………………...

Auditor’s Signature Name Date
…………………………… ……………………………. ……………………

Auditee’s Signature Name Date
6. EFFECTIVENESS OF CORRECTIVE ACTION:
Was the corrective action taken effective? Yes No
Details ( as necessary):
Signed ……………… …………………… ………………

Auditor Name Date
117
EAC Model procedure for Control of Non-Conforming Product

Doc. # EAC/TF-MED/QMS/FD/SOP/N4R0
Logo of NMRA Title: Revision #: 0 Page: 1 of 8

PROCEDURE FOR CONTROL OF
NON-CONFORMING PRODUCT Validity: 2 Years
Number QAO HQM HNMRA
EAC/TF-MED/
QMS/FD/SOP/ Sign ……… Sign ……... Sign ……….. DD/MM/YY DD/MM/YY
N4R0 Date .......... Date .......... Date ..........
1. Purpose Has the responsibility and authority

to initiate corrective actions to
To describe the procedure for identification assure suitability and effectiveness
and control of product which does not conform of the EAC NMRA Investigator /
to products requirements to prevent un auditor as mentioned
intended use or delivery.
3.2 All members of staff who have
2. Scope any involvement or responsibilities
outlined in the SOP or have to
The procedure is applicable for use at NMRA have knowledge of the procedure
headquarter and its geographical locations for outlined must ensure they have
controlling nonconforming products. read the SOP and are fully aware of
their responsibilities and
This procedure covers products that do not accountability in the procedure.
conform to the EAC QMS requirements for the
regulation of medicines, cosmetics, medical All members of staff has the authority
devices and diagnostics. and responsibility to initiate a request for
preventive/corrective action by notifying their
3. Responsibility Department Director
3.1 Head of Quality Management; It is the responsibility of all members of staff

to bring suspected non-conformances with the
Has the responsibility and authority requirements of the QMS to the attention of
to initiate a request for corrective/ the relevant Departmental Manager /Directors
preventive action, verify the or nominated representative.
corrective action for completeness,
close and communicate the
corrective/preventive action results
with the affected department(s).
118
4. Distribution List 5.1.5 All EAC NMRAS staff shall report

non-conforming products identified
a) Head NMRA in their respective working place
to their immediate supervisors/Head
b) Directors of Department, using the non-
conforming products investigation
c) Head/Managers (Departments/ form (NCIF) (see annex …). The
Sections/Division) supervisor/Head of Department
shall review and report the non-
d) Head Quality Management conforming product to the HQM.
e) All Staff (outlook copy) The HQM shall review the non-
conforming product and verify
5. Procedure whether it is significant or not. If
the nonconformity is significant, he/
Identification she shall assign an auditor/
investigator to undertake
5.1.1 Non-conforming products can be the investigation.
detected through internal or
external customer complaints, third Investigation
party audits, internal audit, data
analysis, customer satisfaction 5.1.6 The assigned auditor shall conduct
surveys, relevant Quality a full investigation to determine
Management Systems (QMS) the root cause and corrective
records and process measures to be undertake. A report
measurements. shall be prepared using internal
audit report F04/HNMRA/QM/
Reports of non-conforming products SOP/003 (Annex 1) and submitted
may result from external audits or to the HQM.
may occur as part of routine
operations, where an individual or Decision
department may identify a
non-conformance. The report shall be discussed between the
HQM and the responsible Supervisor/Head
5.1 Recording non-conforming of department and decision arrived at. Where
products applicable, the Head NMRA may be consulted
for further guidance and decisions as may
5.1.4 Non-conforming products identified be necessary.
during auditing shall be treated
as defined in the procedure for
conducting internal audit
119
6. Records 7. References
Records shall include non-conformity EAC QMS Requirements

investigation forms, investigation reports
and any subsequent actions taken including ISO 9001:2008; Quality Management Systems
concessions. The records shall be filed Requirements (Fourth edition 2008-11-15)
in internal audit file and maintained at the
registry office for a period of five years before EAC NMRA Quality Manual
being destroyed by tearing/shredding/burning
or by any other appropriate means.
These should be controlled in accordance with

the procedure for control of documents
Revision No Date Author Section(s) Description Approval

revised of change Process
120
Addendum 1: Non-conforming Product investigation form
EAC NMRA LOGO
F01/HNMRA/QM/SOP/004
Rev #: 01
NON CONFORMANCE INVESTIGATION FORM
Part 1: (To be filled by reporter)
Date: ........................................... Directorate: ............................. Dept/Unit: ....................................
Description of non-conformance: .......................................................................................................
Reported by: ..................................................... Signature: ...............................................................
Part 2: Review of non-conformance by Immediate Supervisor/Head of Department

Comments by supervisor:
Name: ............................................................. Signature: ............................. Date: ..........................
Part 3: Head Quality Management (HQM)
Non-conformity number: ..................................
Is non-conformance significant?
Yes No
If yes go to part 4.
Comments by HQM:
………………………………..…. ………………………………..
Signature of MQM Date
Part 4: Auditor/Investigator
Investigation findings/Root cause Analysis (Attach audit report)
121
Part 5: Recommended correction, corrective action:
.................................................. ................................ ...................................

Investigatee’s name: Signature: Date:
Part 6: Auditor/ Investigator comments on follow up
.................................................. ................................ ...................................

Investigator’s name: Signature; Date:
.................................................. ................................ ...................................

Part 7: Closure of Non-conforming product investigation
.................................................. ................................ ...................................

Investigator’s name: Signature; Date:
.................................................. ................................ ...................................

122
EAC Model procedure for Handling Customer Complaints and Appeals

Doc.# EAC/TF-MED/QMS/FD/SOP/N5R0
NMRA Title: Revision #: 0 Page: 1 of 6

Logo PROCEDURE FOR HANDLING
CUSTOMER COMPLAINTS Validity: 2 Years
AND APPEALS
EAC/TF-MED/
N5R0 Date .......... Date .......... Date ..........
1. Purpose b) The Head of department is

responsible for proposing
The procedure sets out the processes the Corrective and preventive action,
EAC NMRA employs for effective handling and and their implementation
investigation of, complaints and appeals in a
fair, equitable and timely manner. c) The Head of NMRA is responsible
for ensuring that all customer
2. Scope complaints and appeals are handled
appropriately to a satisfactory
The procedure is applicable for use by the conclusion.
EAC NMRAs at the Headquarters and in
NMRA offices in other geographical locations d) All staff of NMRA shall take due
in handling complaints and appeals in relation responsibility in relation to this
to the operations, policies or other activity procedure.
related to, or incidental to the execution of
NMRA’s mandate. 4. Distribution List
3. Responsibility a) Head NMRA
a) The HQM is responsible for b) Directors

coordinating the implementation
of this procedure to ensure c) Head Quality Management (HQM)
that customer complaints and
appeals are received, registered, d) Head Customer Relations
investigated and corrective
actions taken. e) Quality Assurance Officer (QAO)]
f) All Staff
123
5. Procedure 5.5 The transparent customer

complaints and feedback boxes
Receiving and registering customer shall be opened by a designated
Complaints person in the Quality Management
Unit as soon as a complaint form is
5.1 Any person who has a complaint seen inside any of the boxes.
regarding the operation or
implementation of any activity 5.6 Customer.
of NMRA shall fill the Customer
Complaint Report Form Part 1 5.7 All customer complaint report
document number ***** (see forms shall be forwarded to the
Appendix 11.1), available on the Head Quality Management who will
NMRA website (www.NMRA.or.ug), do the following:
NMRA head office or NMRA
branches. a) Stamp the complaint form with a
“Received date” stamp. (See
5.2 Complaints may also be received in Appendix 11.2).
written, verbally, or by telephone. In
this case, the NMRA officer b) Allocate a unique sequential number
receiving complain shall enter to each complaint and write it on the
details of the complaint on the Customer Complaint Report Form
Customer Complaint Report Part 1 and Part 2.
Form Part 1
c) Register the complaint by
5.3 A Complaint may be due to delay or completing the electronic Customer
quality of service delivered, review Complaint Register document
or contract, technical issues, any number ****** (see Appendix 11.3)
misconduct by staff attitude during
service delivery or complaint related d) Fill sections 2.1 to 2.4 of the
to quality and/or safety of regulated Customer Complaint Report Form
products. Part 2 (see Appendix 11.4), make
severity classification of the
5.4 The complainant shall deliver the complaint using the Complaint
filled Customer Complaint Report Severity Classification Criteria,
Form Part 1 to NMRA by dropping Doc. No. ****** (see Appendix 11.5)
it in the secured transparent and submit the form to the HNMRA
Customer complaints and feedback to approve the investigation team.
boxes located at the NMRA head
office or its branches. The complaint e) Send email response to the
may also be sent to the Head NMRA complainant acknowledging receipt
or a designated person as the case of the complaint, within two working
may be by e-mail, fax, post days after receipt of the complaint,
or courier. using standard response format
Doc. No. ***** (see Appendix 11.6).
124
5.8 Where samples or exhibits are a) Nature, type and severity

presented to NMRA together with classification of the complaint
the complaint, the Head Quality
Management shall take photographs b) Objective of the investigation
of the sample and insert their
electronic photo files in the c) Methodology of collecting evidence
electronic Customer Complaints
Register. d) Findings
5.9 The sample or exhibits shall 5.13 The investigation team shall
be preserved throughout the period collect all available evidence, (oral,
of investigation of the complaint. written, primary, secondary), and
ensure that all relevant information
5.10 The head of quality management is obtained and recorded during the
shall send the complaints to the investigation and that the chain of
relevant units/ department evidence is maintained.
responsible for the investigation of
the complaint 5.14 Depending on the nature of
the suspected defect and product,
Investigation of Customer Complaints and the complexity of any further
testing or investigation, it may take
5.11 The relevant department/unit. several weeks before any
shall initiate the investigation of the conclusions can be drawn.
complaint within 72 hours of
receiving the complaint to 5.15 On conclusion of the investigation,
investigate the complaint. the investigation team shall:
The Head of the Department or a) Carry out a root cause analysis and
Unit shall assign an investigation establish the root cause of the
team to undertake the investigation problem
of the reported complaint.
b) Write a detailed report to the Head,
5.12 Persons on the investigation NMRA with recommendations on
team shall not have been involved corrective and preventive actions to
in the original activities in question be taken.
or dispute if their presence may
affect the outcome of the 5.16 The Management team shall,
investigations. review the report of the investigation
team and resolve on the appropriate
In investigating the complaint, action to be taken.
the investigation team shall
determine the following: 5.17 Where the investigation report
is found to be inadequate or
incomplete in resolving the
complaint, the Head, NMRA shall
125
defer the report and refer the matter 5.21 The head of NMRA with the
back to the investigation team or technical input from the investigation
appoint another investigation team team, relevant departments and the
to handle the complaint. Legal Services Unit shall set up
an Appeal Panel to review and
Resolution of a Complaint and Feedback to analyze the appeal.
the Complainant
5.22 The Appeals Panel shall not
5.18 When a complaint has been comprise of individuals or persons
resolved, NMRA shall take the who were involved in the original
following actions: activities in question or dispute.
a) Implement the corrective and/ 5.23 The Appeals Panel shall review the
or preventive actions as per existing and any new evidence/
procedure for Corrective and information and determine if there
preventive Action (refer Doc. No. is sufficient objective evidence to
*****) justify the appeal and shall report its
findings to Management team
b) Communicate to the complainant, in for hearing.
writing, the outcome of the
investigation and the actions taken. 5.24 If the Appeal Panel is appointed
by the NMRA’ s Board then the
c) Advise the complainant to undertake Panel shall report its findings to the
an appeals process within 14 Board, which will then communicate
working days in case of the final decision to the head of
dissatisfaction with the outcome of NMRA for action.
the investigation.
5.25 The head of NMRA shall then
d) Where necessary, arrangements for communicate the decision to the
following-up of any necessary appellants and those in dispute,
corrective and/or preventive actions in writing.
shall be discussed with the
complainant and documented. 5.26 Where no further action is raised
from the appellant or disputing party
Disputes and Appeals concerning the decision within
21 working days, NMRA will
5.19 Where a complaint is not resolved presume the decision to be
to the satisfaction of the satisfactory to the client and
complainant, he/she may appeal the file will be closed by the Head
the decision. Quality Management
5.20 A written appeal against the

resolution of the complaint may be
lodged in by the complainant to the
Head of NMRA.
126
5.27 Where the appellant is not satisfied 7. Data analysis

with the decision of the board, he
or she can seek legal redress 7.1 HQM shall analyse data collected
according the applicable Member from customer complaints
State National Laws register against the quality policy
and quality objectives, clients’
5.28 Summary of all complaints/ service charter, time to deliver
customer feedback shall be service, accuracy, reliability,
reviewed in the management consistence and others to determine
review meetings. opportunity for improvement using
appropriate statistically methods
6. Complaints received at including MS Excel as per
Branches of NMRAs complaints analysis form ****.
6.1 Complaints received at Branches, 7.2 The results of data analysis shall
shall be register and submit a be one of agendas in management
periodic reports shall be sent to review meeting(s).
the head NMRA by the Branch
managers except for those 8. Records
complaints that are beyond their
authority levels particularly policy The records include completed customer
related issues. Such complaints complaint form, customer complaint register
shall be forwarded to the head of and complaints analysis form and shall be filed
NMRA at the headquarters for in customer complaints file and maintained at
action as per clause 7. the register for a period of five years and then
disposed off by tearing/burning/shredding or
6.2 At Branch level, Branch manager any other appropriate method.
shall review the complaint and
conduct investigation (if necessary) 9. References
and communicate the outcome to
the complainant. EAC QMS Requirements
6.3 Depending on the outcome of the ISO 9001:2008; Quality Management Systems
investigations, the Branch manager Requirements (Fourth edition 2008-11-15)
may take corrective action.
ISO/IEC 17020:2012; conformity assessment-
6.4 In case the complainant is not requirements for the operation of various types
satisfied with the outcome/ feedback of bodies performing inspections
on the complaints submitted, the
complainant may appeal to the head EAC NMRA Quality Manual
of NMRA.
127
EAC Model procedure for handling Corrective and Preventive Action

Doc. # EAC/TF-MED/QMS/FD/SOP/N7R0

Logo PROCEDURE FOR HANDLING
CORRECTIVE AND PREVENTIVE Validity: 2 Years
ACTION
EAC/TF-MED/
N7R0 Date .......... Date .......... Date ..........
1. Purpose The head of QMS is responsible for the

coordinating the implementation of the
This procedure describes how corrective and corrective and preventive actions for continual
preventive actions shall be undertaken to improvement of the QMS.
eliminate causes of detected, and of potential
nonconformities within quality management All employees are responsible for
system for continual improvement of services Implementing assigned CAPAs
delivered by NMRA.
4. Distribution List
2. Scope
a) Head NMRA
This procedure is applicable for use in the
EAC NMRAs at the Headquarters and in b) Directors
NMRA offices in other geographical locations
for undertaking corrective actions and c) Head Quality Management (HQM)
preventive action (CAPAs) that affect the
quality of products or services. d) Head Customer Relations
3. Responsibility e) Quality Assurance Officer (QAO)]
The Management is responsible for f) All Staff

reviewing and ensuring that corrective
and preventive actions are implemented
for continual improvement of the quality
management system (QMS).
128
5. Areas to be considered nonconformity relating to product,

processes or quality system.
5.1 Corrective and preventive actions
may be undertaken as a result of, 6.1.3 The responsible department
but not limited to the following:- completes the CA Form No.
***********.
• Complaints
6.2 CA investigation
• Application of new methods
6.2.1 The department or investigation
• Trends established after team will perform a cause-and-effect
data analysis analysis to identify the root cause
and suggest possible corrective
• Internal feedback for improvement actions to eliminate the cause of
detected nonconformity.
• Management review of the QMS
6.3 Identification of required action(s)
• Equipment monitoring
6.3.1 The team in consultation with
• Quality control activities indicating the management shall identify the
need for such actions. most appropriate corrective
action(s) needed to eliminate
• Non conformances the cause of nonconformity and
prevent its recurrence. A cause and
• Audit findings(internal and external) effect analysis may suggest
retraining of staff, amending of
6. PROCEDURE procedures, modifications of space,
among others.
6.1 Corrective Action
6.3.2 Once a Corrective Action has been
6.1.1 The HQM shall collect identified, written and reviewed
information required for analysis of by the CA investigation team in
detected nonconformity. Statistical consultation with the management,
analytical methodology shall a copy will be given to the
be employed where necessary to responsible Department and it
detect recurrence and trends of will be their responsibility to
nonconformity. implement the corrective action(s).
6.1.2 HQM shall issue CA number and 6.4 Verify and validate
assigns the identified CA to the
responsible department 6.4.1 The HQM shall verify and
investigation team which shall validate the Corrective action for
investigate the root cause of purposes of monitoring the
129
implementation of such actions 6.9.2 Actions shall be appropriate to the

to ensure they are effective and effects of the potential
does not adversely affect the goods nonconformities.
and services provided.
6.9.3 Potential nonconformities and
6.5 Implement and record changes their causes shall be determined
during the Management review.
6.5.1 The Head of department shall
ensure that changes in methods 6.9.4 Any staff member can submit a
and procedures are implemented Preventive Action Request
and recorded. Form No. ……
6.6 Disseminate information 6.9.5 These reports are evaluated and

action required to prevent the
6.6.1 The HQM shall ensure that occurrence of nonconformities
information related to the detected is determined.
non-conformity and corrective
action(s) taken is disseminated to 6.9.6 The action required is then
those directly responsible for implemented and documented in
assuring the quality of the the Management Review.
concerned products or services.
6.10 Identification of required action(s)
6.7 Management Review
6.10.1 The team in consultation with
6.7.1 The HQM shall submit relevant the management shall identify
information on implementation of CA the most appropriate preventive
to the management review action(s) needed to eliminate the
cause of potential nonconformity.
6.8 CA closure A cause and effect analysis may
suggest retraining of staff, amending
6.8.1 CA shall be closed as per CA of procedures, modifications of
request form. space, among others.
6.9 Preventive Action 6.10.2 Once a preventive action has been

identified, written and reviewed by
6.9.1 NMRA will determine the action the team in consultation with the
required to eliminate the causes of management, a copy will be given
potential nonconformities in order to the responsible Department and
to prevent their occurrence using it will be their responsibility to
information from quality audit implement the preventive action(s).
results, quality records
and complaints.
130
6.11 Verify and validate 7. Definitions, acronyms and

Abbreviations
6.11.1 The HQM shall verify and
validate the preventive action for Definitions:
purposes of monitoring the
implementation of such actions • Correction: repair, rework or
to ensure they are effective and adjustment and relates to the
does not adversely affect the goods disposition of an existing
and services provided. non-conformity
6.12 Implement and record changes • Corrective Action: an action

taken to eliminate the causes of
6.12.1 The Head of department shall an existing nonconformity, defect or
ensure that changes in methods other undesirable situation in order
and procedures are implemented to prevent recurrence.
and recorded.
• Nonconformity: non-fulfilment of a
6.13 Disseminate information specified requirement.
6.13.1 The HQM shall ensure that • Opportunity: any situation that has
information related to the detected potential to be a problem or an
non-conformity and preventive improvement.
action(s) taken is disseminated to
those directly responsible for • Preventive Action: an action
assuring the quality of the taken to eliminate the cause of
concerned products or services. a potential nonconformity, defect or
other undesirable situation in order
6.14 Management Review to prevent recurrence.
6.14.1 The HQM shall submit relevant • Root Cause Analysis: Root cause
information on implementation of PA analysis is a method used to identify
to the management review the immediate, underlying and root
causes of an incident. The root
6.15 Preventive Action Closure causes are then used to
recommend remedial action that
6.15.1 PA shall be closed as per PA will prevent incidents of a similar
request form. nature taking place in the future.
6.16 Records
6.16.1 Records include CA and PA

request form, cause and effect
analysis report, management review
report shall be documented
and maintained.
131
Acronyms and Abbreviation

EAC: East African Community
NMRA: National Medicines Regulatory Authority
HNMRA: Head of National Medicines Regulatory Authority
QMS: Quality Management System.
CAPA: Corrective and Preventive Action
8. Amendment/Revision History
AMENDMENT / REVISION HISTORY

Date of Particulars of affected Type of changes Effective date
revision document for changes
Issue Rev Section Para

No. No. No.
It is the responsibility of the holder of this document to ensure that

amendments are appropriately implemented
132
133
Model standard operating procedure:

Conducting Management Review Meetings

Logo PROCEDURE FOR CONDUCTING
MANAGEMENT REVIEW MEETINGS Validity: 2 Years
Doc #: Prepared by Checked by Authorized by Effective Date: Review Date:

HQM HNMRA
EAC NMRAs/
HNMRA/QM/
SOP/008 Sign ……… Sign ……... Sign ……….. DD/MM/YY DD/MM/YY
Date .......... Date .......... Date ..........
1.0 Purpose 5.0 Procedure
To describe how management review 5.1 The HQM shall schedule

meetings shall be conducted for the purpose management review meeting at
of reviewing Quality Management Systems least once a year.
(QMS) to ensure that continual improvement.
5.2 Management review meetings shall
2.0 Scope be attended by members of top
management of NMRA and any
The documented procedure applies to NMRAs other staff deemed necessary.
top management for conducting management
review meeting for the QMS. 5.3 The Head of NMRA shall chair the
meeting and HQM shall be
3.0 Responsibility the secretary
The HNMRA is responsible for implementing 5.4 HQM shall draw up agenda for
the resolutions which are made in the meeting. each meeting, which shall include
assessing opportunities for
It is the responsibility of Head Quality improvement and the need for
Management (HQM) to schedule the meeting, changes to the quality management
to prepare the agenda and ensure that system, including the quality policy
meetings are held as planned. and quality objectives.
4.0 Distribution List 5.5 The agenda and supporting

documents with information to
Distribution is done as per documented be discussed during the
procedures for control of documents. management meeting shall be sent
to all members of top management
of NMRA and any other staff
134
deemed necessary, at least two 5.8 The HQM shall record Improvement
weeks before the date of items related to QMS, products
the meeting or services provided or resources
needed shall be recorded as
5.6 During the management review Action Items in the meeting minutes
meeting, the information to be together with identification
presented shall include: of the responsible officers in charge
of implementation or further
5.6.1 results of internal and external investigations.
quality audits,
5.5 Minutes and action items shall be
5.6.2 Customer feedback (complaints, recorded in the management review
compliments, suggestions, etc.) meeting reporting form (indicate
form number)
5.6.3 key performance indicators for the
regulatory processes , 6 Records
5.6.4 status of preventive and corrective Records include management

actions, review minutes, correspondences
and agenda supporting documents
5.6.5 follow-up actions from previous shall be filed in the management
management reviews, review file and maintained as per
documented procedures for control
5.6.6 changes that could affect the quality of records.
management system, and
5.6.7 recommendations for improvement.
5.7 Top management shall make

resolution on areas which includes
actions related to:
5.7.1 improvement of the effectiveness

of the quality management system
and its processes,
5.7.2 improvement of product related to

customer requirements, and
5.7.3 Resources needed.
135
Annex 1: Management review meeting reporting form
NMRAs
NMRA form no.
REV#: 0
MINUTES OF THE MANAGEMENT REVIEW MEETING
…………………………………… ..……..………………………….........

Chairperson Secretary
………………………………...… …..…………………………………….
Date Date
136
PART FIVE
CODE OF CONDUCT FOR EAC PARTNER STATES NMRA
137
O. Introduction It also addresses financial or other interests in

the pharmaceutical industry that could affect
0.1 Background their impartiality.
To be effective, the work of EAC NMRAs must 0.3. Scope

be perceived to be objective and independent
and performed by irreproachable personnel This Code of Conduct applies to the members
who observer the following principles. of the NMRA’s management board, advisory
committees and staff.
a) Integrity
This Code also applies to other persons
b) Objectivity working for the NMRA such as persons
employed under private law contracts, experts
c) Respect for others on secondment, trainees or other relevant
persons.
d) Transparency
0.4. Legal basis
0.2. Objectives
NMRA Partner States have laws and
In order to ensure success of Medicine regulations that govern the code of conduct
Regulation Humanization, each NMRA of public servants. These laws and regulation
needs to: shall be followed in the line with this EAC
code of conduct.
a) Assure the highest personal
standards of integrity, honesty 1. CODE OF CONDUCT
and independence
All NMRA personnel shall behave, conduct
b) Foster the spirit of loyalty and and observe the Code of Conduct as
commitment to the goals of stipulated herein below:
the NMRA
a) Strive to achieve the highest ethical
c) Assure impartiality and discretion and performance standards in
to applicants carrying out medicines regulatory
activities;
d) Develop public confidence in the
transparency of or the NMRA’s b) Uphold the honour and dignity of the
processes. NMRA personnel and avoid
association with any enterprise of
The Code of Conduct sets out the practice for questionable character or apparent
members of the NMRA’s Management Board, conflict of interest;
Advisory Committees, experts and staff on
direct and indirect interests, and the necessity c) Protect and promote the interests
to declare them in order to avoid and manage of the EAC Partner State to the best
potential conflicts of interests. of his/her ability and knowledge,
138
recognizing that the NMRA has l) Not solicit, force or accept bribes
placed trust and confidence onto from a person whom he/she is
him/her; serving, already served or will be
serving either by doing so himself/
d) Strive to acquire new knowledge herself or by using another person;
and skills continuously and use
them effectively; m) Not receive presents in form of
money, entertainments or any
e) Conduct medicines regulatory service from a person that may be
activities in a manner that will regarded as geared to
assure independence from outside compromising his/her integrity;
influence and interest, which would
otherwise compromise his/her ability n) Disclose fraud or abuse of power
to render a fair and impartial opinion and corruption to the top
regarding any medicines regulatory management of NMRA;
activity conducted;
o) Avoid the use of rude and abusive
f) Promptly disclose to the NMRA any language;
interest in any business related to
medicines which may affect p) Report findings truthfully
the quality, or the result of his/her and accurately;
work or remediation;
q) Make decisions in line with
g) Not use his/her position for authorized standards
personal gain; and procedures;
h) Make every effort to uphold, r) Commitment to work;

maintain and improve the integrity
and reputation of the NMRA. s) Conserve customer and NMRA
property and shall not use it for
i) Perform duties diligently, honestly private gain.
and impartially to avoid
circumstances that may lead to t) Endeavour to avoid any actions that
conflict of interest; create an appearance and
circumstance that are violating the
j) Maintain confidentiality whenever law or ethical standards as
accessing confidential information determined by the perspective of a
as a result of medicines regulatory reasonable person with the
activity; knowledge of the relevant facts.
k) Assess facts quickly and take u) Adhere to the laid down laws,
rational and sound decisions regulations, rules and standard
without delay; operating procedures in executing
his/her functions.
139
v) Maintain personal hygiene and or research institution; or an intellectual

dress in respectable attire in property interest, such as a patent or
accordance with acceptable norms copyright. A conflict could also arise where
of the NMRA. NMRA personnel’s participation in an activity
accords him or her access to proprietary
2. GUIDANCE ON CONFLICTS information or gives the NMRA personnel a
OF INTERESTS commercial competitive advantage.
2. 1. Meaning of “conflict 2.2.2. Interests of Others

of interest”
A conflict of interest usually relates to the
In the context of these Guidelines, the term expert’s own interests. However, it could also
“conflict of interest” means any interest in be created by interests of others who may,
any business related to medicines declared or may be perceived to, unduly influence
by NMRA personnel that may affect or the NMRA personnel’s views. A typical
reasonably perceived to affect the quality, or example is where an inspector’s work can
the result of his/her work or remediation. affect or be affected by interests held by the
inspector’s family, rather than the inspector
NMRA’s conflict of interest rules are designed personally. Accordingly, relevant interests of
to avoid potentially compromising situations the inspector’s immediate family members
that could undermine or otherwise affect must be declared. Under these Guidelines,
the work of the NMRA personnel, or activity the term “immediate family member” includes
in which the NMRA personnel is involved the inspector’s spouse and children. “Spouse”
or NMRA as a whole. Consequently, the includes a partner with whom the inspector
scope of the inquiry is any interest that has a similar close personal relationship.
could reasonably be perceived to affect
the functions that the NMRA personnel is In addition, if the NMRA personnel is aware
performing. that the outcome of the medicines regulatory
activity would benefit or adversely affect
2. 2. Types of Interests other parties with whom the inspector has
substantial common interests -- whether
2.2.1. Direct Interest personal, professional or financial -- disclosure
of those affected interests is also necessary.
A conflict of interest is usually financial and Examples of other parties include the
arises where the inspector receives income inspector’s siblings, parents, employer, close
or support that is related to or can affect the professional colleagues, administrative unit or
outcome of the medicines regulatory activity department.
involved. The conflict could involve personal
financial gain, such as consulting income or
honoraria, a business interest, such as a
partnership or joint venture; an investment,
such as stocks or bonds; financial support
for research from the private sector given
directly to the inspector or to his university
140
2.2.3. Public statements and positions 5. DOI Forms should be completed

and submitted by the concerned
NMRA personnel’s independent judgment party and evaluated by NMRA
could also be affected by public statements before the concerned party begins
made and positions held. For example, an to perform the tasks. This is
inspector may have taken a definite position necessary in order to enable
related to a manufacturer to be inspected by the NMRA to make a conflict
providing testimony as part of a regulatory or assessment in relation to medicines
judicial process. The inspector may serve on regulatory activity and the interests
a board or hold an office in an organization held at that time by the concerned
that has taken a position, on the subject, and party.
he or she is expected to represent or defend
it. To the extent that such public statements 6. If the concerned party decline to
and positions are declared in a DOI Form and/ complete a DOI Form, or if he/she
or known to the relevant NMRA, then such refuses to disclose a potentially
information must be subject to a conflict of significant conflict to NMRA, the
interest assessment. concerned party must not be
permitted to participate in the
2.3. When is the NMRA personnel NMRA tasks.
required to complete a
declaration of interests form? 2.4. Examples of interests that
must be disclosed
1. All NMRA personnel must complete
Declaration of Interest (DOI) form 1) Financial interests and investments
( see Annex 1) before their (stocks, compensation or
recruitment can be confirmed and otherwise);
during the course of employment.
2) Financial support for research
2. Board members and advisory activities provided by the private
committee members shall complete sector directly to the NMRA
this form during their swearing in personnel or indirectly to his/her
ceremony and before any meeting. university or research institution;
3. Expert and consultants shall 3) Patents or other form of intellectual

complete this DOI form before property that are held by a
providing any expertise or concerned party or that he/she is
consultancy to the NMRA. a beneficiary of and that relate to
the subject matter of the activity;
4. A DOI Form must be completed
whenever NMRA personnel are 4) Consultancies, employment
asked to participate in medicines relationships or other external
regulatory activities in a personal professional activities as well as the
capacity and/or as representative of name of the entities with whom the
his or her institution. concerned party has or has had a
141
relationship as well as a general 2. An affirmative answer in the DOI

statement of the duration of such Form does not automatically
relationship, if known; disqualify the concerned party.
Rather, affirmative answers are
5) Speaking fees from, or sponsored screened by the NMRA to determine
participation in, lectures, symposia if a potential conflict of interest
and seminars. exists.
Examples of disclosure statements: 3. The NMRA should request from the

concerned party both an updated
a) Shareholding in applicant curriculum vitae (CV) where
pharmaceutical industry applicable. The NMRA should
evaluate the responses in the DOI
b) Short-term or long-term consultancy Form in conjunction with information
for applicant pharmaceutical in the concerned party CV, since
industry one may provide relevant
information that is not apparent from
c) Travel and/or accommodation paid the other.
by applicant pharmaceutical
2.6. Safety of the filled DOI forms
d) When the concerned party is
involved in a business related or 1. All completed DOI Forms will be
similar to that of the applicant. kept confidential and will only
be used to evaluate whether
e) Has received any amount of money the NMRA personnel’s declared
or gifts with a value of more than interests constitute a real, potential
200 USD from the applicant within or apparent conflict of interests. The
the past 2 years. form itself is a working document
of the NMRA and should not be
2.5. How to analyse the distributed or made public, also
information disclosed? to protect legitimate privacy
concerns of the inspectors. In this
1. The DOI Form consists of a series regard, the concerned unit in NMRA
of questions requesting disclosure should not in any statement or
of any interest relevant to the document relating to a piece of work
medicines regulatory activity state that the DOI Form itself will be
activities to be performed in which made available to the public or any
the NMRA personnel has been other third party.
invited to participate. If the inspector
answers any question in the 2. DOI forms should be retained by
affirmative, he/she is asked to the concerned unit for at least
supply further details at the end of five years. The DOI Forms should
the form. be filed and maintained in a
manner consistent with general
procedures for the retention of
142
confidential documents. In In the course of discharging NRMA functions

particular, the Forms should rNMRA NMRA personnel and other concerned
in the custody of a senior officer of persons will gain access to certain information,
the concerned unit in segregated which is proprietary to the NMRA or entities
files kept in a locked cabinet. collaborating with the NMRA, including the
regulated industry. They undertake to treat
3. GUIDANCE ON such information (hereinafter referred to as
CONFIDENTIALITY “Confidential Information”) as confidential
and proprietary to the NMRA or the aforesaid
3.1. Introduction parties collaborating with the NMRA.
Confidentiality is a set of rules or a promise 3.2 Confidential Information

that limits access or places restrictions on
certain types of information. “Confidential Information” shall include
all information or material that has or could
EAC NMRAs have been entrusted with the have commercial value or other utility in the
important duty of protection of public health business in which Disclosing Party (Herein
and the evaluation of medicinal products referred to as NMRA’s clients or suppliers) is
on behalf of consumers, patients and the engaged.
pharmaceutical industry. Members of the
Management Board, members of advisory NMRA personnel should be required to
committees, experts and NMRA staff members complete and submit the confidentiality
must treat information on the NMRA work with agreement (annex II) after been permitted to
the utmost discretion and confidentiality. participate in the medicines regulatory activity
but before tasks of medicines regulatory
EAC NMRAs face potentially conflicting activity begun.
obligations, requiring them to weigh the duty
to protect public health, transparency and All NMRA personnel shall be bound by this
granting public access to documents, with the confidentiality undertaking.
need to respect confidentiality of information
that the NMRA holds, where appropriate as 3.3 Duty of confidentiality
legally required.
All NMRA personnel shall be bound by this
Significant amount of information will be confidentiality undertaking;
available and shared among EAC Partner
States NMRAs. This access to information a) To protect personal data and
within the EAC, however, shall be balanced respect confidential information
by the rules of professional secrecy for NMRA among the EAC NMRA,
personnel and other concerned persons and pharmaceutical companies
the obligation to respect EAC and international and patients;
laws on the protection of commercially
confidential data in the pharmaceutical sector. b) to exercise care when answering
questions so as not to supply
information to third parties regarding
143
specific products where this k) Not to speak directly to journalists

information is not public; and the wider media without
express permission from the head
c) to exercise discretion when of the NMRA.
discussing professional work with
third parties, including family and l) To seek guidance from the top
friends, and with colleagues or third management in case of doubt.
parties in a public place, e.g.
restaurant, public transport; However the NMRA personnel will not be
bound by any obligations of confidentiality
d) not to use the Information for and non-use to the extent that they are clearly
any other purpose than discharging able to demonstrate that any part of the
your employment obligations; Information:
e) Not to use the information for a) was known to you prior to any
commercial purpose disclosure by or on behalf of the
NMRA (including by the
f) not to disclose or provide the manufacturer(s)); or
Information to any person who is not
bound by similar obligations of b) was in the public domain at the time
confidentiality and non-use as of disclosure by or on behalf of the
contained herein. NMRA (including the
manufacturer(s)); or
g) undertake not to communicate
your deliberations and findings c) becomes part of the public domain
and/or those of other employees, through no fault of your own; or
as well as any resulting
recommendations to, and/or d) becomes available to you from
decisions of, the NMRA to any a third party not in breach of any
third party, except as explicitly legal obligations of confidentiality.
agreed by the NMRA.
3.4. Continuing duty
h) To ascertain the provenance of the of confidentiality
party putting a question and when
needed for the party to put NMRA’s management board, advisory
in writing; committees, staff, other persons working for
the NMRA such as persons employed under
i) To apply common sense when private law contracts, experts on secondment,
answering indirect questions trainees and other relevant persons have a
seeking to obtain information life-long duty of confidentiality even after they
have ceased their relationship with the NMRA.
j) To follow a laid down procedures This covers all information of the kind covered
for handling of requests for access by the obligation of professional secrecy.
to information; NMRA staff are required to behave with
144
integrity and discretion after leaving the NMRA 3.5. When is the NMRA personnel
for a period of two years following departure required to complete a
from the NMRA. Former NRMA staff should confidentiality undertaking
not exploit their relationship with former
form?
colleagues to obtain professional advantage
or information of a specific or regulatory nature
1. All NMRA personnel must
for personal advantage. NMRA shall apply a
complete Confidentiality
distance policy to former staff to ensure that its
Undertaking (CU) form (see Annex
interests are protected and that such problems
2) before their recruitment can
do not arise.
be confirmed and during the course
of employment.
Staff leaving the NMRA are able to use
the skills acquired in the course of their
2. Board members and advisory
employment at the NMRA so long as such
committee members shall complete
use is, for a period of two years, not in conflict
this form during their swearing in
with the legitimate interests of the service
ceremony and before any meeting.
and does not interfere with their obligation of
confidentiality.
This is, in particular, intended to prevent

3. Expert and consultants shall
breaches of confidentiality that would be
complete this CU form before
detrimental to the public interest, interests of
providing any expertise or
the NMRA, EAC Partner States, applicants or
consultancy to the NMRA.
holders of marketing authorisations.
4. If the NMRA personnel decline to
complete the CU form, then he/she
must not be recruited or engaged
in NMRA.
145
ANNEX 1: DECLARATION OF INTERESTS
1) Instructions for declaration All NRMA personnel must also promptly

of conflict of interest inform the NMRA if there is any change in this
information prior to, or during the course of
Members of the Board, advisory committees their service to the NMRA.
and Staff of NMRAs, including other persons
working for the NMRA such as persons Answering “Yes” to a question on this form
employed under private law contracts, experts does not automatically disqualify you from
on secondment, trainees or other relevant service to the NMRA. Your answers will be
personsmay have interests related to their reviewed by the NMRA to determine whether
work. you have a conflict of interest relevant to the
subject at hand. One of the outcomes listed in
To ensure the highest integrity and public the next paragraph can occur depending on
confidence the NMRA personnel mentioned the circumstances (e.g, nature and magnitude
above shall disclose any circumstances that of the interest, timeframe and duration of the
could represent a potential conflict of interest interest).
(i.e. any interest that may affect, or may
reasonably be perceived to affect, the NRMA The NMRA may conclude that no potential
personnel’s objectivity and independence). conflict exists or that the interest is irrelevant
or insignificant. If, however, a declared interest
The NMRA personnel must disclose on is determined to be potentially or clearly
this Declaration of Interest (DOI) form any significant, one or more of the following three
financial, professional or other interest measures for managing the conflict of interest
relevant to the NMRA. They must also may be applied.
declare relevant interests of their immediate
family members (see definition below) and, The NMRA may:
if they (Staff, Board members and advisory
committee) are aware of it, relevant interests a) allow full employment, with public
of other parties with whom they (staff) have disclosure of your interest;
substantial common interests and which
may be perceived as unduly influencing their b) mandates partial exclusion (i.e., you
judgment (e.g. employer, close professional will be excluded from that portion
associates, administrative unit or department). of the work related to the declared
interest and from the corresponding
All staff must complete this form before their decision making process); or
recruitment can be confirmed and during the
course of employment. c) mandates total exclusion (i.e., you
will not be employed).
Board members and advisory committee
members shall complete this form during
their swearing in ceremony and before any
meeting.
146
Completing this DOI form means that you 2. Form for Declaration
agree to these conditions. If you are unable or of Interest
unwilling to disclose the details of an interest
that may pose a real or perceived conflict, Please answer each of the questions below.
you must disclose that a conflict of interest If the answer to any of the questions is “yes”,
may exist and the NMRA may decide that you briefly describe the circumstances on the last
be totally excluded from the meeting or work page of the form. The term “you” refers to
concerned, after consulting with you. yourself and your immediate family members
(i.e., spouse or partner with whom you have
Where there is sufficient evidence that the a similar close personal relationship and your
NMRA personnel has conflict of interest children).
relevant to the NMRA and failed to disclose
such conflict of interest on the Declaration “Commercial entity” includes any
of Interest (DOI) form this may lead to commercial business, an industry association,
disciplinary action being taken against the research institution or other enterprise
concerned personnel. whose funding is significantly derived from
commercial sources with an interest related to
the NMRA.
“Organization” includes a governmental,

international or non-profit organization.
Name and Surname: ..........................................................................................................................

Position: .............................................................................................................................................
147
EMPLOYMENT AND CONSULTING
Within the past 4 years, have you received remuneration from a commercial entity or
other organization with an interest related to NMRA work?
Yes No
1a Employment

1b Consulting, including service as a technical or other advisor

Previous year: Yes No
Name of company + product name :………………………………………………............................
(please specify dates): .................................................................................................................
More than 1 year ago but less than 3 years ago: Yes No
Name of company + product name : …………………………………………...............................
(please specify dates): ................................................................................................................
More than 3 years ago: Yes No
Name of company + product name: ………………………………………………............................
(please specify dates): .................................................................................................................
RESEARCH SUPPORT
Within the past 4 years, have you or has your research unit received support from a
commercial entity or other organization with an interest related to NMRA work?
Item Yes No
2a Research support, including grants, collaborations, sponsorships,

and other funding

2b Non-monetary support or gift valued at more than US $250 overall
(include equipment, facilities, research assistants, paid travel to
meetings, etc.). Support (including honoraria) for being on a speaker’s
bureau, giving speeches or training for a commercial entity or other
organization with an interest related to NMRA services?

If yes give details:
148
INVESTMENT INTERESTS
Do you have current investments or business (valued at more than US$ 5000 overall) in
a commercial entity with an interest related to the NMRA? Please also include indirect
investments such as a trust or holding company. You may exclude mutual funds,
pension funds or similar investments that are broadly diversified and on which you
exercise no control.
Item Yes No
3a Stocks, bonds, stock options, other securities (e.g., short sales)
3b Commercial business interests related to NMRA work

(e.g., proprietorships, partnerships, joint ventures, board memberships,
controlling interest in a company)
INTELLECTUAL PROPERTY
Do you have any intellectual property rights that might be enhanced or diminished by
working with the NMRA?
Item Yes No
4a Patents, trademarks, or copyrights (including pending applications)
4b Proprietary know-how in a substance, technology or process
PUBLIC STATEMENTS AND POSITIONS (during the past 4 years)
Item Yes No
5a As part of a regulatory, legislative or judicial process, have you

provided an expert opinion or testimony, related to regulated products,
for a commercial entity or other organization?
5b Have you held an office or other position, paid or unpaid, where

you represented interests or defended a position related to
regulated products?
149
ADDITIONAL INFORMATION
Item Yes No
6a If not already disclosed above, will your work enable you to obtain
access to a competitor’s confidential proprietary information, or
create for you a personal, professional, financial or business
competitive advantage?
6b To your knowledge, would the outcome of the work benefit or

adversely affect interests of others with whom you have substantial
common personal, professional, financial or business interests
(such as your adult children or siblings, close professional colleagues,
administrative unit or department)?
6c Excluding NMRA, has any person or entity paid or contributed

towards your travel costs in connection with this NMRA work?
6d Is there any other aspect of your background or present

circumstances not addressed above that might be perceived as
affecting your objectivity or independence?
EXPLANATION OF “YES” RESPONSES: If the answer to any of the above questions is

“yes”, check above and briefly describe the circumstances on this page. If you do not describe
the nature of an interest or if you do not provide the amount or value involved where relevant,
the conflict will be assumed to be significant.
150
Nos. 1 - 4: 7 Name of Belongs to you, a Amount of income Current

company, family member, or value of interest interest (or
Type of interest, organization, or employer, research (if not disclosed, is year ceased)
question number and institution unit or other? assumed to be
category (e.g., significant)
Intellectual Property
4.a copyrights) and
basic descriptive
details.
Nos. 5-6: Describe the subject, specific circumstances, parties involved, time frame and other
relevant details
DECLARATION
I hereby declare on my honor that the disclosed information is true and complete to
the best of my knowledge. Should there be any change to the above information, I will
promptly notify the NMRA and complete a new declaration of interest form that describes
the changes. This includes any change that occurs before or during the meeting or work
itself and through the period up to the publication of the final results or completion of the
activity concerned.
Date: ......................................................... Signature .................................................................
151
ANNEX 2: CONFIDENTIALITY DECLARATION
....... In the course of discharging your functions as an NMRA staff, you will gain access
to certain information, which is proprietary to the NMRA or entities collaborating with
the NMRA, including the regulated industry. You undertake to treat such information
(hereinafter referred to as “the Information”) as confidential and proprietary to the NMRA
or the aforesaid parties collaborating with the NMRA. In this connection, you agree:
a) not to use the Information for any other purpose than discharging your employment
obligations; and
b) not to disclose or provide the Information to any person who is not bound by similar
obligations of confidentiality and non-use as contained herein.
However, you will not be bound by any obligations of confidentiality and non-use to the extent that
you are clearly able to demonstrate that any part of the Information:
a) was known to you prior to any disclosure by or on behalf of the NMRA [including by the
manufacturer(s)]; or
b) was in the public domain at the time of disclosure by or on behalf of the NMRA
[including the manufacturer(s)]; or
c) becomes part of the public domain through no fault of your own; or
d) becomes available to you from a third party not in breach of any legal obligations
of confidentiality.
You also undertake not to communicate your deliberations and findings and/or those of other
employees, as well as any resulting recommendations to, and/or decisions of, the NMRA to any
third party, except as explicitly agreed by the NMRA.
You will discharge your responsibilities under the terms of employment. In this connection, you
confirm that the information disclosed by you in the Declaration of Interest is correct and that no
situation of real, potential or apparent conflict of interest is known to you, including that you have
no financial or other interest in, and/or other relationship with, a party, which:
a) may have a vested commercial interest in obtaining access to any part of the
Information referred to above; and/or
b) may have a vested interest in the outcome of the evaluation of the product(s), in which
you will participate (such as the manufacturers of those products or of competing
products).
You undertake to promptly advise the NMRA of any change in the above circumstances, including
if an issue arises during the course of your employment with the NMRA.
I hereby accept and agree with the conditions and provisions contained in this document.
Signed: ............................................ Place: ......................................... Date: ...................................

Name (typewritten):
152
EAST AFRICAN COMMUNITY SECRETARIAT

EAC CLOSE
P.O.BOX 1096
ARUSHA, TANZANIA

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DOCUMENT NO: EAC/TF-MED/QMS/FD/COM/N1R0

DOCUMENT NO: EAC/TF-MED/QMS/FD/COM/N1R0

COMPENDIUM OF QUALITY MANAGEMENT

VERSION SEPTEMBER 2014

DOCUMENTS DEVELOPMENT HISTORY

Finally, I would like to acknowledge regional

Ambassador Dr. Richard Sezibera

The “Compendium of Quality Management The East African Community Quality

1. The East African Community This document is mainly based on ISO

3. The Model Manual on the The Model Manual on the Implementation

5. Code of Conduct for Partner The mandatory documented procedures

Hon. Jesca Eriyo

RESPONSIBILITY FOR IMPLEMENTATION AND

........................ ........................ ........................ ........................ ........................

Cabinet Minister Minister Minister for Minister of State

REPUBLIC OF UNITED REPUBLIC OF REPUBLIC OF REPUBLIC OF

AUTHORS/CONTRIBUTORS Inyangala Mwende Ronald; Director,

Nyawakira Anicet Burhani Othman Simai

Inyangala Mwende Ronald Habib Ali Shariff

Kipkerich C. Koskei Oteba Olowo Martin

Fred Moin Siyoi Bamenyekanye Emmanuel

Hiiti B. Sillo Dr. Ramana NV Gandham

Dr. Andreas Seiter Hetzke Juorg

Dr.Vincent Ahonkhai Margareth Ndomondo Sigonda

DOCUMENTS DEVELOPMENT HISTORY i

PART ONE: EAC QUALITY MANAMEGENT REQUIREMENTS 1

QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS 3

3. Terms and definitions 4

4. Quality management system 4

5.6. Management review 8

8. Measurement, analysis and improvement 17

8.2. Monitoring and measurement 17

PART TWO: EAC GUIDELINES FOR IMPLEMTATION OF QMS 22

QUALITY MANAGEMENT SYSTEM 23

3. Terms and definitions 23

4. Quality Management System 24

5.4.2 Quality management system planning 32

6.0 Resource management 35

7.0 Product realization 38

7.5.5 Preservation of product 49

PART THREE: Model Manual on the Implementation of the EAC QMS 58

QUALITY MANAGEMENT SYSTEM 60

3. TERMS AND DEFINITIONS 60

4. QUALITY MANAGEMENT SYSTEM 61

7.0 Product realization 66

8.0 Measurement, analysis and improvement 70

PART FOUR: EAC QMS Model Standard Procedures 86

1. CODE OF CONDUCT 138

2. GUIDANCE ON CONFLICTS OF INTERESTS 140

3. GUIDANCE ON CONFIDENTIALITY 143

ANNEX 1: DECLARATION OF INTERESTS 146

EAC QUALITY MANAMEGENT’S REQUIREMENTS

0. INTRODUCTION 0.2. Objectives

0.1. Background The overall objective of this document is

EAC NMRAs should co-operate with one

QUALITY MANAGEMENT a) ISO/IEC 17025: 2005 – General

1. Scope b) ISO/IEC 17020: 2012 Conformity

c) ISO/IEC 17020: 2012 Conformity NOTE 3

d) PI 002_3: 2007 PIC/S - b) “Product” : Applies to regulatory