MASTER OF PHARMACY

M.Pharm-Drug Regulatory Affairs

Goal: It is very essential for the pharmacists to have a thorough knowledge and understanding of
the regulatory requirement of pharmaceutical industry. Students will be trained in areas of
CGMP, Documentation, drug discovery and development process, validation, GCP, GLP and
quality management system.
Regulatory requirement for drug development, product approval, pre clinical and clinical trials
and patent laws will be studied in detail.

 CGMP, Drug laws, Drug discovery and development process

 Process validation of APIs and finished products, water, sterile and non sterile facility,
medical devices, analytical methods.
 Concept of TQM, regulatory audits, ICH Process, GLP, GCP
 Stability testing
 Generic drug development process
 Non clinical drug development
 Clinical trials

SYLLABUS
M. Pharm – Drug Regulatory Affairs

Paper Subject

I Current Good Manufacturing Practices (cGMP)

and Documentation

II Pharmaceutical Validation

III Quality Management systems

IV Pharmaceutical Regulatory Requirements

 PAPER - I
Current Good Manufacturing Practices (cGMP) and Documentation
Goals:
To impart in depth study of good manufacturing practices in an industrial set up including
drug laws, drug discovery and development process

THEORY  75 HOURS
1. cGMP of Pharmaceutical manufacturing · Evolution and Principles of cGMP, 15 Hrs
20 Marks
Schedule-M, WHO-GMP requirements, European Union (EU) and United
States Food and Drug Administration (USFDA) guidelines on Pharmaceutical
manufacturing.

2. Organization and personnel responsibilities, training, hygiene and personal 10 Hrs

20 Marks
records, drug industry location, design, construction and plant lay out,
maintenance, sanitation, environmental control, utilities and maintenance of
sterile areas, control of contamination and Good Warehousing Practice.

3. Packaging of Dosage Forms: cGMP complied packaging and documentation 06 Hrs

10 Marks
Labeling requirements of various regulated and non-regulated markets for
Tablets, Capsules, Liquid Orals, Parenterals/ Injectables, and Semisolids.

4. Equipments selection & purchase specifications, maintenance, clean in place, 06 Hrs

10 Marks
purchase specifications and maintenance of stores for raw materials.

5. In process quality control and finished products quality control for following 10 Hrs
10 Marks
formulation in Pharma industry: tablets, capsules, ointments, suppositories,
creams, parenterals, ophthalmic and surgical products.

6. Documentation in pharmaceutical industry: Batch Formula Record, Master 10 Hrs

10 Marks
Formula Record, Distribution records. Common Technical Document and Drug
Master Files., Medical Devices, Electronic Common Technical Documentation

7. An introductory study of following laws with regard to drug product design, 10 Hrs
10 Marks
manufacture and distribution in India (with latest amendments) :
a. Drugs and Cosmetics Act 1940 and its rules 1945
b. National Pharmaceutical Pricing Authority (NPPA)
c. The Environmental Protection Act-1986 & Occupational Safety and
Health Administration (OSHA)
d. Consumer Protection Act-1986
e. Factories Act-1948 and Pollution control Act-1989
f. Law of Contracts (Indian contract Act-1872)
g. Monopolistic & Restrictive Trade Practices Act-1969
h. Law of Torts
i. Pharmaceutical inspection convention guide for cGMP

8. Drug discovery and development process: Principles of Drug discovery and 08 Hrs
20 Marks
development. Clinical research process. Development and informational
content for Investigational New Drugs Application (IND), New Drug
Application (NDA), handling of Orange book, Abbreviated New Drug
Application (ANDA), Supplemental New Drug Application (SNDA), Scale Up
Post approval changes (SUPAC) and Bulk active chemical Post approval
 changes (BACPAC). Post marketing surveillance, Current Biopharmaceutical
regulations and in particular related to Cell Therapy and regenerative medicine.

RECOMMENDED BOOKS

1. Good Manufacturing Practice Rationale and compliance by John Sharp

2. Pharmaceutical master validation plan: The ultimate guide to FDA, GMP and GLP
Compliance by Syed Imitiaz Haider
3. Pharmaceutical dosage forms: Parenterals Vol-2, II Edition, by Kenneth EA and Leon
Lachman
4. Packaging and Pharmaceuticals and health care products by H. Lockhart, Frank A.
Paine
5. The process of new drug discovery and development. I and II Edition by Charles G.
Smith, James T and O. Donnell.
6. Establishing a CGMP laboratory audit system- A Practical guide by David M.
Bliesner.
7. J.F.Hanlon: Hand book of package engineering :Mac-Grawhill company
8. Good manufacturing practices: A plan total quality control: S.H.Wilhing, M.M.
Tuckerman, S.Hitchings, Marcel Deckker, Inc. Yew york.
9. Cell therapy, CGMP, Facilities and Manufacturing, Springer

PRACTICALS : (6 Hours per week)

Twenty Assignments to be carried out and submitted on the aforementioned theoretical

aspects like
1. Documentation for in process and finished products Quality control tests for Solid,
Semisolid and Sterile preparations.
2. Protocol preparation for purchase of manufacturing equipments and raw materials.
3. Protocol preparation for documentation of various types of records ( BFR, MFR, DR,
etc.)
4. Labeling comparison between brand & generics. (Review of Promotion Materials)
 PAPER - II
Pharmaceutical Validation -
Goals:
To develop competency in international guidelines in the area of validation methods,
processes, equipments etc.
';J
THEORY 50 HOURS

1. An Introduction to the Basic Concepts of Process Validation & How it Differs 07 Hrs
from Qualification (Installation Qualification (IQ), Operational Qualification 10 Marks
(OQ) & Performance Qualification (PQ) Procedures, Validation master plan ~
(VMP)

2. A Review of Prospective, Concurrent, Retrospective Validation & Revalidation 04 Hrs

including the use of Statistical Process Control (SPC) 10 Marks
:.1
3. Planning & Managing a Validation Program including Change Control, 08 Hrs
Scale-Up and Post-Approval Changes (SUPAC), Pre Approval Inspections (PAI) 20 Marks ,I
& Technology Transfer Issues

4. Validation of Water (Demineralised, Distilled and Water for Injection) & 03 Hrs
Thermal Systems, including Heat Ventilation and Air conditioning (HVAC), 10 Marks
Facilities & Cleaning Validation

5. Process Validation of Active Pharmaceutical Ingredients (APIs) and finished 07 Hrs

products. 10 Marks "~

Data generation and storage, quality control documents, retention samples, .]

records and audits of quality control facilities. Finished products release, quality
review, quality audits, batch release document -,
:,
-~
6. Validation of Sterile and Non-Sterile Facility 08 Hrs
20 Marks

7. Medical Device, In Vitro Diagnostics & Packaging Validation Issues 03 Hrs

10 Marks

8. Validation of Analytical Methods, Automated Systems, International 10 Hrs

Conference on Harmonization (ICH) and World Health Organization (WHO) 20 Marks

Guidelines for calibration of equipments, Validation of process: mixing,

granulation, drying, compression, filtration, filling, Validation of sterilization
methods and equipments: dry heat sterilization, autoclaving, membrane
filtration. Validation of analytical procedures, Validation of air handling
equipments and facilities in sterile and non sterile areas.
 RECOMMENDED BOOKS

1. Pharmaceutical Process Validation, 3rd Edition, Edited by Robert Nash and Alfred
Wachter, Marcel Dekker
2. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control
from Manufacturer to Consumer, Sidney J. Willig, Marcel Dekker, 5th Ed.
3. Validation of Pharmaceutical Processes: Sterile Products, Frederick J. Carlton (Ed.) and
James Agalloco (Ed.), Marcel Dekker, 2nd Ed.
4. Validation Standard Operating Procedures: A Step by Step Guide for Achieving
Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Syed Imtiaz
Haider
5. Pharmaceutical Equipment Validation: The Ultimate Qualification Handbook, Phillip A.
Cloud, Interpharm Press
6. Pharmaceutical Quality Assurance by Manohar A. Potdhar, 2nd edition, Nirali Prakashan.

PRACTICALS: (6 Hours per week)

Twenty Assignments to be carried out and submitted on the aforementioned theoretical
aspects like
 Preparation of protocols on various validation requirements
 Validation of machines & analytical instruments used for Pharmaceutical formulations.
 Process Validation of various pharmaceutical dosage forms.
 Validation of medical devices.( viz., Nebulizers, Inhalers, Infusion pump, Insulin pens)
 Cleaning Validation
 Analytical methods Validation
 PAPER – III
Quality Management systems
Goals:
Learning the system of quality audit, regulatory requirements, quality evaluation, GLP, GCP
concepts etc.
THEORY 50 HOURS

1. Concept of Quality, Total Quality Management. Quality by design, six sigma concept 06 Hrs
10 Marks

2. Auditors, Auditing strategies and preparation of audits, Quality audit & audit check 07 Hrs
lists and Auditing of manufacturing facilities by International regulatory agencies. 10 Marks
Conducting and Handling of internal/Domestic/International Regulatory Audits/
Customer specific audits /Pre approval inspections,

3. Harmonization of regulatory requirements-The International Conference on 10 Hrs

Harmonization (ICH) process, guidelines to establish quality, safety and efficacy of 20 Marks
drug substances and products. Study of ICH common technical documents,
harmonization of pharmacopoeial standards The International Organization for
Standardization (ISO) 9000 series of quality systems standards, ISO 14000

4. Quality evaluation and batch release: Change Control, Deviation-(planned and 07 Hrs
unplanned), Corrective Action and Preventive Action (CAPA), Handling of non- 20 Marks
conformance, Vendor evaluation process, Out of specification (OOS), batch
reconciliation and finished goods release, Market recalls & Market complaints.

5. Good Laboratory Practices (GLP): Scope of GLP, Quality assurance unit, Standard 04 Hrs
operating procedures (SOP), protocols for conduct of non clinical testing, control on 10 Marks
animal house, report preparation and documentation.

6. National Accreditation Board for testing and Calibration Laboratory (NABL) 03 Hrs
certification and accreditation procedure 10 Marks

7. Stability testing: ICH and WHO guidelines, Photostability studies 07 Hrs

10 Marks

8. Good Clinical Practices (GCP): International regulatory requirements for 06 Hrs

pharmaceutical development regarding clinical research practices. Current issues in 20 Marks
GCP; standards for design, conduct, performance, monitoring, auditing, recording,
analysis, and reporting of clinical trials. Schedule Y of Indian Drugs and Cosmetics
Act 1940, Role of Regulatory affairs in Product development, Clinical phase,
Preclinical Phase, Manufacturing phase and Marketing Phase. Indian Council of
Medical Research (ICMR) Guidelines for Ethics in Biomedical Research.
RECOMMENDED BOOKS

1. Quality planning and Analysis by JM Juran and FM Gryna, Tata McGrawHill- India.
2. Total Quality Management, Dale H. Besterfield, Pearson Education, 3rd Ed., 2003.
3. Total Quality Management, Principles, Implementation & Cases, Sharma D.D., Sultan
Chand & Sons, New Delhi, 2000.
4. Fundamentals of Total Quality Management, Process Analysis and Improvement by
Jens.J Daulgard, Kai Kriestensen and Gopal K.Kanji. Taylor and Francis
5. Total Quality Management, Organization, and Strategy, James R. Evans, Thomson, 4th
Ed., 2007.
6. Quality Control, Besterfield, D.H., Pearson, 7th Ed., 2004.
7. Implementing ISO 14000: a practical, comprehensive guide to the ISO 14000
environmental management standards, Authors: Tom Tibor, Ira Feldman , Editors: Tom
Tibor, Ira Feldman, Irwin Professional Pub., 1997.
8. Establishing A cGMP Lab; Audit System- A practical guide, David M.Bleisner, Wiley
Interscience.
9. The manager's guide to ISO 9000, Kenneth L. Arnold, Free Press, 1994.
10. How To Practice GLP, Good Laboratory Practice, Sharma PP, Vandana Publications
11. GLP Essentials: A Concise Guide to Good Laboratory Practice, Second Edition, Milton
A. Anderson, Informa Healthcare.
12. GLP Quality Audit Manual, Milton A. Anderson, Third Edition, Informa Healthcare.
13. Laboratory Auditing for Quality and Regulatory Compliance, by Donald C.Singer, Stefan
and Stedan, Drugs and Pharmaceutical Sciences, Vol.150
14. Handbook of Stability Testing in Pharmaceutical Development: Regulations,
Methodologies, and Best Practices, Huynh-Ba, Kim, Springer.
15. International Stability Testing, Mazzo J. Mazzo, David J. Mazzo, Informa Healthcare
Pharmaceutical Stability Testing To Support Global Markets (biotechnology:
Pharmaceutical Aspects), Kim Huynh-ba, Springer.
16. Good Laboratory Practice Regulations, Third Edition, Revised and Expanded Edited by
Sandy Weinberg
17. Handbook of Stability Testing in Pharmaceutical Development: Regulations,
Methodologies, and Best Practices, Kim Huynh-ba, Springer.
18. Good Clinical Practice: Standard Operating Procedures for Clinical Researchers, Wiley.
19. Laboratory Auditing for quality and regulatory compliance, Donald C. Singer, Taylor and
Francis.
20. Current Good Manufacturing Practices, MA Potdhar, BS Publications.

PRACTICALS: (6 Hours per week)

Twenty Assignments to be carried out and submitted on the aforementioned theoretical
aspects like
1. Preparation of SOPs for various equipments and manufacturing processes as per ISO
requirements.
2. Quality control tests on Solid, liquid, semisolid and sterile dosage forms
3. Accelerated and Photostability studies on dosage forms as per ICH Guidelines
4. Preparation of final clinical trial report (Phase I,II and III) for submission to regulatory
authorities.
5. Documentation for audits and inspection of manufacturing facilities.
6. Report preparation of GLP for non-clinical testing
 PAPER – IV

Pharmaceutical Regulatory Requirements

Goals:
To develop competency in product development, regulatory requirement for product approval,
FDA regulations and guidelines, preclinical and clinical trial regulations and requirements.
Theory 50 HOURS
1. Generic Drug Product development: Introduction, Quality Control and 10 Hrs
Quality Assurance (QC &QA), Hatch-Waxman update, Drug product 20 Marks
performance- in vitro, ANDA Regulatory Approval Process, Bioequivalence
and Drug Product Assessment- in vivo, Scale up Post approval changes, Post
marketing surveillance, Outsourcing Bioavailability and Bioequivalence
studies to Contract Research organizations. Formats for marketing
authorization submission to US, EU, Asia-PAC (includes countries of East
Asia, southeast Asia, Australasia, Oceania) etc., Data privacy Protection and
Intellectual property, patents, Pharmaceutical Labeling, Advertising and
Promotion, Risk Management in regulatory affairs

2. Regulatory requirements for product approvals: Active Pharmaceutical 08 Hrs

Ingredients, Biologics, Novel therapies, special categories [ Over the counter 20 Marks
(OTCS), herbal medicines and Homeopathic] obtaining New Drug
Application (NDA), Abbreviated New Drug Application (ANDA)for generic
drugs, ways and means of US Registration for foreign drugs, Chemistry,
Manufacturing and controls (CMC), Post approval Regulatory affairs,
Regulation for combination products (Controlled release systems), medical
device, Environmental concerns and regulations

21 Code of Federal Regulations (CFR) Part 11 and LIMS (Laboratory

information Management System).

3. FDA Approvable indications and other considerations: Data procession for 08 Hrs
Global submission, Text and Tabular exposition- Common Technical 20 Marks
Document (CTD)/ electronic Common Technical Document (eCTD) Format,
working with contract Research Organization (CRO), Industry and FDA
Liaison, Role of European Commission Competent Authorities and Notified
Bodies and USFDA Authorities

4. Nonclinical drug development: Global submission of Investigational New 08 Hrs

Drug application (IND), New Drug application (NDA), Abbreviated New 20 Marks
Drug Application (ANDA), Investigation medicinal product Dossier (IMPD)
& Investigator Brochure (IB), New product Applications for Global
Pharmaceutical Product approvals, US NDA vs Global CTD Formats, ANDA
& Supplemental Abbreviated New Drug Application (SNDA), CTD and
eCTD for registration of pharmaceuticals for Human use, combination
products (Controlled release systems).
5. Clinical trials: Developing clinical trial protocols, Institutional Review Board/ 08 Hrs
Independent Ethics committee-formation and working procedures, Informed 10 Marks
consent-process and procedures, HIPAA- A new requirement to clinical study
process, Code of Federal Regulations (CFR)/ International Conference on
Harmonization (ICH)/EU GCP obligations of Investigators, sponsors &
Monitors, Importance of Quality Assurance in clinical trials, Managing and
Monitoring clinical trials, European clinical trials (CT) directives-
implementation and update., Pharmacovigilance-safety monitoring in clinical
trials.
 6. International legal consideration: BXA (Bureau of export administration),
EAR (Export administration regulation), ECCN (Export control classification 08Hrs
10 Marks
number), STELA (System for tracking export license application), FCPA
(Federal corrupt practice act), EPA (Environmental protection agency
regulation), SFD (Securities & exchange commission).

RECOMMENDED BOOKS
1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader
Kaufer, Marcel Dekker series, Vol.143
2. The Pharmaceutical Regulatory Process, Edited by Ira R. Berry Marcel Dekker
Series,Vol.144
3. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and
Robert P. Martin, Drugs and the Pharmaceutical Sciences,Vol.185
Informa Health care Publishers.
4. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino,
MD, 5th edition, Drugs and the Pharmaceutical Sciences, Vol.190.
5. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons.
Inc.
6. FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics
/edited by Douglas J. Pisano, David Mantus.
7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By
Fay A. Rozovsky and Rodney K. Adams
8. HIPAA and Human Subjects Research: A Question and Answer Reference Guide By
Mark Barnes, JD, LLM and Jennifer Kulynych, JD, PhD
9. Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin
and Frederick P. Ognibene
10. Drugs: From Discovery to Approval, Second Edition By Rick Ng
11. New Drug Development: A Regulatory Overview, Eighth Edition By Mark Mathieu
12. Pharmaceutical Risk Management By Jeffrey E. Fetterman, Wayne L. Pines and Gary H.
Slatko
13. Preparation and Maintenance of the IND Application in eCTD Format By William K.
Sietsema
14. Medical Device Development: A Regulatory Overview By Jonathan S. Kahan
15. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical DevicesBy
John J. Tobin and Gary Walsh

PRACTICALS : (6 Hours per week)

Twenty Assignments to be carried out and submitted on the aforementioned theoretical

aspects like

 Preparation of regulatory compliance checklist tabulating cGMP requirements as per 21

CFR 210 and 211.
 Preparation of global list of documents for registration of IND, NDA, ANDA as per ICH
CTD format.
 Preparation of Annual report for regulatory on approved ANDA
 Case studies on response with scientific rationale to USFDA Warning Letter
 Preparation of an IMPD for EU submission.
 Preparation of a Clinical Trial Protocol for submission to Regulatory.
 Preparation of regulatory compliance requirements for BA/BE study.
 Preparation and documentation for Indian Patent.
 Patent challenge / non infringement (Para IV) case studies.
 Preparation of Annual Product Quality Review (APQR).
  Preparation of Periodic Safety Update Report (PSUR).
 Comparison of key GMP requirements of India, US, EU and Japan of a dosage form.
 Comparison of Clinical Trial Application Requirements of India, US, EU and Japan of a
dosage form.
 Fast track approval in different countries considering different class of drugs (e.g. Anti
HIV and anticancer), therapeutic area (rare diseases) etc.
 Annotated side by side comparison of labels, Prescribing Information and Patient
Information Leaflet.
 Preparation of generic product registration application as per Association of South East
Asian Nations [ASEAN] CTD (ACTD)

Preparation of a marketing authorization application for OTC, homeopathic and Herbal

Medicinal Product.