GMP CHECK LIST

Clause Number C/NC/O Description verified By Auditor

1. Principle

1.1 Is person involved in the implementation activities

described have provided appropriate training to
produce, control and store products with defined
quality.

1.2 Organization

1.2.1 Organization Chart

1.2.1.1 Is organization structure defined in proper order

and appropriate for the size of the company and the
diversity of its products?
1.2.1.2 Is the organization chart shows the
independence, from other units of the plants and
responsibilities are properly understood within
departments/ employees?

1.2.2 Number of People

1.2.2.1 Is the organization has an adequate number of

properly trained personnel with regards to defined
activities performed in the organization?
1.3 Key Responsibilities
1.3.1 Management Responsibilities
1.3.1.1 Is the organization supported by Top
management of the company?
1.3.1.2 Is the responsibility for the implementation of
Good Manufacturing Practices falls under top
management and require participation and commitment
of personnel in all departments and at all levels within
the organization?
1.3.1.3 Is the Management has defined and
communicate the area in which authorized personnel
are allowed to access?
1.3.2 Responsibilities of Personnel
1.3.2.1 Is all personnel:
a) know their position in the organizational structure;
b) know their defined responsibilities and activities;
c) have access to and comply with documents relevant
to their particular responsibility scope;
d) comply with personal hygiene requirements;
e) be encouraged to report irregularities or other non-
conformities which may occur at the level of their
responsibilities;
f) have adequate education training and skills to
perform the assigned responsibilities and activities.
1.4 Training
1.4.1 Training and Skills
Is Personnel involved in production, Control, Storage
and shipment has skills based on relevant training and
experience acquired, or any combination thereof, that
are appropriate to their responsibilities and activities.
1.4.2 Training and Good Manufacturing Practices
1.4.2.1 Is appropriate training relevant to Good
Manufacturing Practices provided for all personnel?
1.4.2.2 Is the training needs of all personnel, regardless
of level or seniority in the company identified and a
corresponding training programme has developed and
implemented.
1.4.2.3 Is the training courses are tailored appropriate to
the jobs and responsibilities of individuals, considering
the expertise and experience of the respective
personnel?
1.4.2.4 Is training courses designed and executed by the
company itself or with the help of expert external
organizations, if necessary.
1.4.2.5 Training provided in constant and on-going
process that is subject to regular updates.
1.4.3 Newly recruited personnel
Is basic induction training planned and provided to
newly recruited personnel.
1.4.4 Personnel training evaluations
Is knowledge accumulated by personnel evaluated
during and/or after training?

1.5 Personnel hygiene and health

1.5.1 Personnel hygiene

requirements should be understood and

1.5.1.1 Is hygiene programmes has established and followed by every person whose activities take
adopted to the needs of the organization? them into production,
control and storage areas.
1.5.1.2 Is there instruction provided to use hand
washing facilities.

1.5.1.3 Are every person entering into the production,

control and storage areas wear proper work wear to
avoid any contamination?
1.5.1.4 Are personnel refrain themselves from eating,
chewing, smoking or storage of food, drink or personal
medication in the production, control and storage
areas?
1.5.1.5 Is unhygienic practice within the production,
control and storage areas or in any other area where the
product might be adversely affected forbidden?
1.5.2 Personnel health
Is Steps taken to ensure, as far as is practicable, that any
person affected by an apparent illness or
having open lesions on the exposed body surface
excluded from direct contact with product until
the condition is corrected or determined by medical
personnel that the quality of finished products will not
be compromised?
1.6 Visitors and untrained personnel

Have the visitors and untrained personnel given

information in advance, particularly about personal
hygiene and the prescribed protective clothing. Are they
closely supervised?
2. Premises
2.1 Principle
2.1.1 Is the Premises located, designed, constructed and
utilized so as:
a) to ensure protection of the product;
b) to permit efficient cleaning, if necessary, sanitizing
and maintenance;
c) to minimize the risk of mix-up of products, raw
materials and packaging materials.
2.2 Types of area
Is there Separate or defined areas provided for storage,
production, quality control, ancillary, washing and
toilets.
2.3 Space
Is Sufficient space provided to facilitate operations such
as receipt, storage and production?

2.4 Flow

Is Flow of materials, products and personnel through

the building or buildings defined in order to prevent
mix-ups?
2.5 Floors, walls, ceilings, windows
2.5.1 Is Floors, walls, ceilings and windows in production
areas designed or constructed for ease of cleaning and,
if necessary, sanitization and kept clean and in good
repair.
2.5.2 Are windows of non-opening design where
ventilation is adequate and screened properly If
windows are opened to the outside environment?
2.5.3 Do new construction of production areas
incorporate considerations for proper cleaning and
Maintenance? Do Design of new construction include
smooth surfaces if appropriate and these surfaces allow
for resistance to corrosive cleaning and sanitizing
agents?
2.6 Washing and toilet facilities
Are adequate, clean, washing and toilet facilities
The washing and toilet facilities are
provided for personnel? Are adequate facilities for
differentiated from, but accessible to,
showering and changing clothes provided when
production areas.
appropriate?
2.7 Lighting
2.7.1 Does adequate lighting, that is sufficient for
operations, should be installed in all areas?

2.7.2 Do Lighting installed in a manner to ensure

containment of any debris from potential breakage. Or
measures taken to protect the product.
2.8 Ventilation

Does ventilation sufficient for the intended production

operations?

2.9 Pipework, drains and ducts

2.9.1 Does Pipework, drains and ducts installed in such a

manner so that drip or condensation do not
contaminate materials, products, surfaces and
equipment.
2.9.2 Do Drains are kept clean and not allow back flow.
2.9.3 Do considerations for design given to the
following:
a) exposed overhead roof beams, pipes and ducts to be
avoided;
b) exposed pipes not to touch walls, but be suspended
from or supported by brackets, sufficiently separated to
allow thorough cleaning;
c) alternatively, specific measures to be taken to protect
the product

2.10 Cleaning and Sanitation

2.10.1 Is premises maintained in a clean condition?

2.10.2 Do Cleaning & Sanitation carried out to achieve
the objective of protecting each product.
2.10.3 Does Cleaning & Sanitizing agent used specified
and effective?
2.10.4 Is there any cleaning & sanitization programmes
corresponding to specific needs of each area identified if
required and proper cleaning regime practised?

2.11 Machinery/ Equipment / Maintenance

2.11.1 Are machinery and equipment convenient to

affective disinfection?
2.11.2 Are illumination devices in storages, production
area protected?
2.12 Consumables
Do Consumables used for premises affect the quality of
the product?
2.12 Pest Control
2.12.1 Is there an active pest control system
available?
2.12.2 2.13.2 Is there a pest control/management file
exists? (E.g. MSDS reports…etc.)
2.12.3 Is Pest management system implemented
effectively?
2.12.4 Is there any risk as cross contamination of
drinking/using water, foods, personnel form chemicals
using Pest management/ control process?
2.12.5 Is there a sub-contracted Pest Control/
Management company?
2.12.6 Are there responsible staffs of pest control/
management?
3. Equipment
3.1 Do equipment suitable for the intended purpose,
capable of being cleaned and, if necessary, sanitized and
maintained?
3.2 Equipment Design
3.2.1 Do Production equipment designed to prevent
contamination of the product?
3.2.2 Are Bulk product containers protected from air
contaminants, such as dust and moisture
3.2.3 Are Transfer hoses and accessories that are not in
use are cleaned and, if necessary sanitized, kept dry and
protected from dust, splash or other contamination?
3.2.4 Do the material used in the construction of
equipment is compatible with products and the cleaning
and sanitizing agents.

3.3 Installation
3.3.1 Do the design and the installation of equipment
ease its drainage in order to facilitate cleaning and
sanitization?
3.3.2 Can equipment be placed so that movement of
materials, mobile equipment and personnel do not pose
a risk to quality?

3.3.3 Do reasonable access under, inside and around

equipment provided for maintenance and cleaning?
3.3.4 Do Major equipment readily identifiable.
3.4 Calibration
3.4.1 Do Laboratory and Production measuring
instruments that are important for the quality of the
product, calibrated regularly.
3.4.2 Do measuring instruments are appropriately
identified and removed from service If results of
calibration are out-of-acceptance criteria?

3.4.3 Is there any facility for investigation on an out-of-

calibration condition to determine if there is any impact
to the quality of the product and appropriate steps
taken based on this investigation?

3.5 Cleaning and Sanitation

3.5.1 Do all equipment is subject to an appropriate
cleaning and, if necessary, sanitization programme.
3.5.2 Are Cleaning and sanitizing agents specified and
effective?
3.5.3 If equipment is assigned to continuous production
or production of successive batches of the same
product, equipment are cleaned and, sanitized at
appropriate intervals?
3.6 Maintenance
3.6.1 Do Equipment are regularly maintained.
3.6.2 Do Maintenance operations affect the quality of
the product?
3.6.3 Do Defective equipment identified accordingly,
excluded from use and isolated if possible?
3.7 Consumables
Do Consumables used for equipment affect the quality
of the product?
3.8 Authorizations
Do Equipment or automated systems used in production
and control are accessed and used by authorized
personnel?
3.9 Back-up Systems
Do adequate alternative arrangements are available for
systems which need to be operated in the event of a
failure or breakdown?
4. Raw materials and packaging materials
4.1 Principle

Do Raw materials and packaging materials that are

purchased meet defined acceptance criteria relevant to
the quality of finished products?
4.2 Purchasing
Do Purchasing of raw materials and packaging materials
based on:
a) evaluation and selection of the supplier;
b) establishment of technical clauses such as type of
selection to be conducted, acceptance criteria, actions
in the case of defect or modifications, transport
conditions;
c) setting of relations and exchanges between the
company and supplier such as questionnaire, assistance
and audits
4.3 Receipt
4.3.1 Do, the purchase order, the delivery note and the
delivered materials match.
4.3.2 Do the integrity of the raw materials and
packaging materials shipping containers are checked?
4.4 Identification and status
4.4.1 Do containers of raw materials and packaging
materials labelled in order to identify the material and
the batch information?
4.4.2 Do Raw materials and packaging materials that
shows defects that might affect product quality held
pending a decision?
4.4.3 DO Raw materials and packaging materials are
identified in an appropriate way according to their
status? (such as accepted, rejected or quarantined)

4.4.4 Does the Identification of raw materials and

packaging materials contain the following information:
a) name of the product marked on the delivery note;
b) name of the product as given by the company, if
different from the name given by the supplier and/or its
code number;
c) date or number of receipt, if appropriate;
d) supplier’s name;
e) batch reference given by the supplier and the one
given at receipt, if different.
4.5 Release
4.5.1 Physical or alternative systems are set up to
ensure that only released raw materials and packaging
materials are used.
4.5.2 Does the release of materials carried out by the
authorized personnel responsible for quality.
4.5.3 Does the Raw materials and packaging materials
accepted on the basis of the supplier certificate of
analysis only if there are established technical
requirements, experience and knowledge of the
supplier, supplier audit and agreed supplier’s test
methods?
4.6 Storage
4.6.1 Do Storage conditions appropriate for each raw
material and packaging material?
4.6.2 Do Raw materials and packaging materials are
stored and handled in a manner appropriate to their
characteristics?
4.6.3 Does Specific storage conditions monitored, where
appropriate?
4.6.4 Do containers of raw materials and packaging
materials are closed and are stored off the floor?
4.6.5 When raw materials and packaging materials are
repacked, are they carry the same labelling as at origin?
4.6.6 When raw materials and packaging materials are
quarantined or rejected, are they stored in their
respective physical locations or by using any other
system providing the same level of assurance?
4.6.7 Do measures set up to ensure stock turnover.
Except in special circumstances, stock rotation ensures
that the oldest released stock is used first.
4.6.8 Do Periodic inventory performed to ensure stock
reliability.
4.7 Re-evaluation
Is there any system established to re-evaluate materials
as appropriate to determining their suitability for use,
after a defined period of storage. Is there any system in
place to prevent the use of materials which require re-
evaluation?
4.8 Quality of Water used in production
4.8.1 Do water treatment system supply a defined
quality of water?
4.8.2 Do water quality verified by either testing or
monitoring of process parameters?
4.8.3 Do water treatment system permit sanitization?
4.8.4 Do Water treatment equipment set up available so
as to avoid stagnation and risks of contamination?
4.8.5 Do Materials used in water treatment equipment
selected to ensure that water quality is not affected?
5 Production
5.1 Principle
At each stage of manufacturing operations and
packaging operations, are there any measures to
produce a finished product that meets the defined
characteristics?
5.2 Manufacturing operations
5.2.1 Availability of relevant documents
5.2.1.1 Do relevant documentation available at each
stage of manufacturing operations?
5.2.1.2 Do manufacturing operations carried out
according to manufacturing documentation,
including:
a) suitable equipment;
b) formula for the product;
c) list of all raw materials identified according to
relevant documents indicating batch numbers and
quantities;
d) detailed manufacturing operations for each stage,
such as addition of raw materials, temperatures,
speeds, mixing times, sampling, cleaning and, if
necessary, sanitizing of equipment, and bulk product
transfer.
5.2.2 Start-up checks
Before starting any manufacturing operations, do
organization has facility to ensure:
a) all documentation relevant to the manufacturing
operations is available;
b) all raw materials are available and released;
c) suitable equipment is available for use, in working
order, cleaned and, if necessary, sanitized;
d) clearance of the area has been performed to avoid
mixing with materials from previous operations.
5.2.3 Assignment of a batch number
Do a batch number assigned to each batch of This number does not need
manufactured bulk product? to be identical with the batch number that
appears on the label of the finished product,
but, if not, it should be
easy to relate to that number
5.2.4 Identification of in-process operations
5.2.4.1 Do all raw materials measured or weighed In
accordance with the formula, into clean and suitable
containers labelled with appropriate identification or
directly into the equipment used for manufacturing?
5.2.4.2 Is it possible to identify major equipment,
containers of raw materials and containers of bulk
products?
5.2.4.3 Do Identification of containers of bulk products
indicate:
a) name or identifying code;
b) batch number;
c) storage conditions when such information is critical to
assure the quality of the product.
5.2.5 In-process control
5.2.5.1 Do In-process controls and their acceptance
criteria defined?
5.2.5.2 Do In-process controls performed according to a
defined programme?
5.2.5.3 Is there any system in place for any result
outside the acceptance criteria to be reported and
appropriately investigated?
5.2.6 Bulk Product Storage
5.2.6.1 Do Bulk product stored in suitable containers, in
defined areas, and under appropriate conditions?
5.2.6.2 Do maximum bulk product storage duration
defined?
5.2.6.3 Is there any facility to re-evaluate the bulk
products when this duration is reached, before use?
5.2.7 Re-stocking raw materials
Is there any Facility established if raw materials found If raw materials remain unused after weighing
unacceptable? and are intended and deemed acceptable to
return to stock, their containers should be
closed and properly identified.
5.3 Packaging Operations
5.3.1 Availability of relevant documents
5.3.1.1 Do relevant documentation available at each
stage of packaging operations.
5.3.1.2 Do Packaging operations carried out according to
packaging documentation including:
a) suitable equipment;
b) list of packaging materials defined for the intended
finished product;
c) detailed packaging operations such as filling, closing,
labelling, and coding.
5.3.2 Start-up checks
Do the organization has established facility to ensure
the following:
a) the area has been cleared of materials to avoid
mixing with materials from previous operations;
b) all documentation relevant to the packaging
operations, is available;
c) all packaging materials are available;
d) suitable equipment is available for use, in working
order, cleaned and, if necessary, sanitized;
e) any coding to permit identification of the product is
defined.
5.3.3 Assignment of batch number
5.3.3.1 Does there a batch number assigned to each unit This number does not need to be identical
of finished product? with the batch number that appears on the
label of the
bulk product, but, if not, it should be easy to
relate to that number.
5.3.4 Packaging line identification

5.3.4.1 Is there any facility to identify the packaging At all times, it should be possible to identify
line? the packaging line with its name or identifying
code, the name or
identifying code of the finished product and
the batch number
5.3.5 Checks of on-line control equipment
Is there any facility for on-line control equipment
regularly checked according to a defined programme?
5.3.6 In-process control
5.3.6.1 Is in-process controls and their acceptance
criteria defined?
5.3.6.2 Is there any defined program established to
perform for in-process control
5.3.6.3 If any result that is outside the acceptance
criteria, is there any facility established to report and
investigates accordingly?
5.3.7 Re-stocking of Packaging materials
Is there any facilities available to maintain any unused If packaging materials remain unused after
packaging operation? packaging operations and are intended and
deemed acceptable to return to stock, their
containers should be closed and properly
identified.
5.3.8 Identification and handling of work-in-process
Are there any special measures present for segregation Filling and labelling is usually a continuous
and identification so that no mix-ups or mislabelling process. Where this is not the case, special
occur? measures including segregation and
identification should be applied so that no
mix-ups or mislabelling can occur.
6. Finished Products
6.1 Principle
Do storage, shipment and returns managed in a manner
so as to maintain the quality of finished products.
6.2 Release
6.2.1 Are there facility established to control finished Prior to being placed on the market, all
products with compliance with acceptance criteria? finished products should be controlled in
accordance with established test methods and
should comply with acceptance criteria.
6.2.2 Do product release carried out by authorized
personnel responsible for quality.
6.3 Storage
6.3.1 Do finished products stored in defined areas under Finished products should be stored in defined
appropriate conditions for an appropriate length of areas under appropriate conditions for an
time? appropriate
length of time. If necessary, finished products
should be monitored while stored.
6.3.2 Do storage areas permit organized storage
process?
6.3.3 Storing system for finished products. When finished products are released,
quarantined or rejected, they should be
stored in their respective physical locations or
by using any other system providing the same
level of assurance.
6.3.4 Do Identification of finished product containers
indicate:
a) name or identifying code;
b) batch number;
c) storage conditions when such information is critical to
assure the quality of the product;
d) quantity.
6.3.5 Is there any provision for Periodic inventory
checks, to ensure:
a) ensure inventory accuracy;
b) ensure that acceptance criteria are met.
6.4 Shipment
Is there any measures taken to ensure the shipment of
the defined finished product?
Do precautions taken to maintain the finished product
quality when appropriate.
6.5 Returns
Is there Provision of returned product, their storage,
verification and disposition?
7 Quality Control laboratory
7.1 Testing
7.1.1 Is there any control established for perform test
on basis of defined, appropriate an available test
methods.
7.2 Acceptable criteria
Is there any acceptance criteria established to specify
the requirements to be met for raw materials,
packaging materials, bulk products and finished
products?
7.3 Results
Do any provision for reviewing of results? Is there any
facility for approval, rejection or pending?
7.4 Out-of-specification results
7.4.1 Is there any provision for reviewing out-of-
specification results by authorized personnel and proper
investigation facility available?
7.5 Reagents, solutions, reference standards, culture
media
Do Reagents, solutions, reference standards, culture
media, etc. identified by the following information:
a) the name;
b) its strength or concentration, when appropriate;
c) expiration date, when appropriate;
d) the name and/or signature of the person who
prepared it, when appropriate;
e) opening date;
f) storage conditions, when appropriate.
7.6 Sampling
7.6.1 Do sampling performed by authorized personnel?
7.6.2 Do sampling defined in terms of :
a) sampling method;
b) equipment to be used;
c) amounts to be taken;
d) any precautions to be observed to avoid
contamination or deterioration;
e) identification of sample;
f) frequency.
7.7 Retain sample
7.7.1 Do samples of finished product retained in
appropriate manner and in designated areas.
7.7.2 Do sample size of finished products allow analyses
to be carried out in accordance with local regulations?
8 Treatment of product that is out of specification
8.1 Rejected finished products, bulk products, raw
materials and packaging materials
8.1.1 Do Investigations of rejected products or materials
performed by personnel authorized to do so.
8.1.2 Do authorized personnel responsible for the
decisions to destroy or to reprocess of out of
specification products.
8.2 Reprocessed finished products and bulk products
8.2.1 Is there provision for part of a batch of finished
product or bulk product doesn’t match the defined
acceptance criteria?
8.2.2 Is there any method of reprocessing defined and
approved?
8.2.3 Is there any authorized person present to review
the result in order to verify the conformity of the
finished product or bulk product with acceptance?
9 Wastes
9.1 Principle
Do wastes disposed of in a timely and sanitary manner?
9.2 Types of waste
Do types of waste defined by the organization?
9.3 Flow
9.3.1 Does the flow of waste impact the production and
laboratory operations.
9.3.2 Do appropriate measures taken concerning
collection, transportation, storage and disposal of
Wastes?
9.4 Containers
9.4.1 Do containers of waste properly identified as to
contents and other information, as appropriate?
9.5 Disposal
Does the disposal of waste performed in an appropriate
way with an adequate level of control?
10 Subcontracting
10.1 Is there any written contract or agreement
established, mutually confirmed and controlled
between the contractor and the organization?
10.2 Types of Subcontracting
Kind of sub-contractor involves in process operation
11 Deviations
11.1 Does deviations from specified requirements
authorized by designated person to support the
decision?

11.2 Does the corrective action made to prevent

recurrence of the deviation.
12 Complaints and recalls
12.1 Principle
Is there any provision to review, investigate and
followed-up the complaints.

12.2 Product Complaints

Do complaints followed-up include:
a) steps to prevent recurrence of the defect;
b) checking other batches in order to determine
whether they are also affected, where appropriate.
13 Change Control
Is there any control established for any changes that approved and performed by authorized
could affect the quality of product? personnel on the basis of sufficient data
14 Internal Audit
Does organization has established process to conduct its
internal audit to determine the suitability of Good
Manufacturing practices?
Does the organization has Planned, Schedule an internal
audit programme?
Does the organization take proper follow-up for the
findings that rose from internal audit?
15 Control of Documents
Does the organization have established process to
control of documents and record?
Does the organization have appropriate review,
approval process for the documentation?