GMP AUDIT CHECKLIST Page 1 of 32

INSPECTION OF: Date:

Full Address of Company: Products manufactured Location of production

Inspection type: mark all that apply Names of Inspectors: Affiliation of Inspectors:
external { }
routine { } _________________ ____________________
internal { }
follow-up, { } _________________ ____________________
re-inspection { }
_________________ ____________________

_________________ ____________________

_________________ ____________________

_________________ ____________________

Department(s) being inspected Date(s) of inspection: Date of most recent previous routine
inspection (Internal or external)

From
_____________________
_________________ ____________________
_____________________
To
_____________________
_________________ Type: ______________
_____________________
Normal working hours: ______________
_____________________ QA audit report #_______
_________________

Floor plans of facility available? Airflow patterns, differential Flow patterns for personal,
pressures, and classification of supplies, raw materials, product,
production areas indicated? and waste for production areas
indicated?
Y { } N{ } Y { } N{ } Y { } N{ }
GMP AUDIT CHECKLIST Page 2 of 32

INSPECTION OF: Date:

SUMMARY OF SENIOR PERSONNEL, A: (use next of these departmental divisions are not
appropriate, or for other department designations)

ADMINISTRATION
Position Title Name

_____________________________ _____________________________

_____________________________ _____________________________

_____________________________ _____________________________

PRODUCTION DEPARTMENT
Position Title Name Qualifications

_____________________________ ________________ __________________

_____________________________ ________________ __________________

_____________________________ ________________ __________________

_____________________________ ________________ __________________

ENGINEERING / MAINTENANCE
Position Title Name Qualifications

_____________________________ ________________ __________________

_____________________________ ________________ __________________

QUALITY CONTROL DEPT

Position Title Name Qualifications

_____________________________ ________________ __________________

_____________________________ ________________ __________________

QUALITY ASSURANCE DEPT

Position Title Name Qualifications

_____________________________ ________________ __________________

_____________________________ ________________ __________________

GMP AUDIT CHECKLIST Page 3 of 32

INSPECTION OF: Date:

SUMMARY OF SENIOR PERSONNEL, B: (use for additional departments or different organizational

divisions)

_____________DEPARTMENT
Position Title Name Qualifications
________________________ ___________________ ___________________

________________________ ___________________ ___________________

________________________ ___________________ ___________________

_____________DEPARTMENT
Position Title Name Qualifications
________________________ ___________________ ___________________

________________________ ___________________ ___________________

________________________ ___________________ ___________________

_____________DEPARTMENT
Position Title Name Qualifications
________________________ ___________________ ___________________

________________________ ___________________ ___________________

________________________ ___________________ ___________________

_____________DEPARTMENT
Position Title Name Qualifications
________________________ ___________________ ___________________

________________________ ___________________ ___________________

________________________ ___________________ ___________________

_____________DEPARTMENT
Position Title Name Qualifications
________________________ ___________________ ___________________

________________________ ___________________ ___________________

________________________ ___________________ ___________________

_____________DEPARTMENT
Position Title Name Qualifications
________________________ ___________________ ___________________

________________________ ___________________ ___________________

________________________ ___________________ ___________________

GMP AUDIT CHECKLIST Page 4 of 32

INSPECTION OF: Date:

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Is there an organizational chart? Attach org chart, add other
What departments are identified? departments or Indicate
Production departments(s) departments different from list.
__________________

__________________

__________________

__________________

Filling { }
Labeling/Packaging { }
Quality control { }
Engineering/Maintenance { }
Quality Assurance { }
Receiving/Warehousing { }
Shipping/Distribution { }
Purchasing { }
2 Are there job descriptions for key
personnel?
Are they appropriate to the activities of
the department?
3 Number of engineering staff____
Number sufficient?
Qualifications adequate?
Experience sufficient?
Number of production staff____
Number sufficient?
Qualifications adequate?
Experience sufficient?
Number of quality control staff____
Number sufficient?
Qualifications adequate?
Experience sufficient?
Number of quality assurance staff____
Number sufficient?
Qualifications adequate?
Experience sufficient?
4 Is there a Clear separation of
responsibility for production from QC?
5 Is there a clear separation of personnel
from different areas handling process
And product by
written
procedure ?
written procedure?
6 Are the names and qualifications of
those responsible for approving the lot
processing records registered with the
NCA?
GMP AUDIT CHECKLIST Page 5 of 32

INSPECTION OF: Date:

1.0 B: Key Personnel

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are there sufficient key personnel to
supervise assigned functions?
Production
Filling
Labeling / Packaging
Quality Control
Engineering
Maintenance
Quality Assurance
Other departments:
_____________________________

_____________________________

2 Are they skilled/trained in fields such

industrial engineering,
Engineering
Production Departments)
Filling
Quality Control
Quality Assurance
Other: __________________

1.0 C: Training

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are there on the job training procedures
for new employees?
2 Are training and education records
available?
Are they current?
Are they filed with the supervisor?
Engineering/Maintenance
Production Department(s)
Filling
Quality Control
Quality Assurance
Other departments
______________________

3 Does a GMP training programme exist?

For new employees?
Annual update for all staff?
Are records maintained
4 Is there training in containment
procedures?
By written procedures?
Are records maintained?
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1.0 D: Personal Hygiene

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are appropriate protective apparel
required?
Is there gowning SOP for production
staff?
For other staff entering production
areas?
(Engineering/Maintenance; Cleaners;
QC samplers; QA auditors)
For staff in the Quality Control Lab?
2 Are staffs instructed to report health or
medical problems that may have an
adverse effect on the product?
3 Is there a medical monitoring
programme to ensure protection of staff
and product?
4 Do controlled entry requirements exist
for:
Production areas?
Testing areas?
Animal areas?
Do procedures exist for preventing
unauthorized entry into:
Production areas?
Storage areas?
Quality control areas?
Are the procedures in writing?
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2.0 A: General

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Is the building used for manufacturing
of product suitably located and
constructed, and of adequate sizes to
facilitate cleaning, maintenance and
proper operation?
2 Are areas clearly defined and
appropriately controlled.
a. For quarantine and storage of starting
materials?
b. For storage of in-process material?
c. For manufacturing and processing
operations?
d. For control and laboratory operations?
e. For quarantine and storage of finished
products?
f. For holding of rejected material?
g. For ancillary usage, e.g. rest rooms,
maintenance workshops?
3 Does the building design prevent the
entry of insects, vermin and other
animals?
4 Plumbing
a Do adequate drains exist? Are they
designed with an atmosphere break to
prevent back-siphon age from sewer?
b Are traps being maintained to ensure
adequate performance?
5 Does the design of the facility achieve
a unidirectional flow of materials,
personnel, product and waste so as to
avoid crossover of clean and dirty
(infectious) material?
6 Is the lighting provided adequate for
the conditions necessary for the work
being conducted in the area?
7 Are facility layout drawings including
mechanical, electrical and architectural
kept up-to date following changes?
Is re validation of facilities performed
following reimbursement?
8 Campaign production
a. Is the facility designed and constructed
to permit production in campaigns?
b. Has campaign changeover been
validated (effectiveness of changeover)
c. Is there a documented procedure for
changeover that described
decontamination, removal of
equipment, etc?
d. Is there a campaigning schedule
available?
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2.0 A: General continued

# Audit Item Yes No NA Observations (indicate
N.O. if not observed)
9 Do washing facilities include:
a. Hot and cold water?
b. Soap and detergent?
c. Clean toilet facilities that are easily
accessible to working area
10 Are the premises satisfactory with
respect to:
a. Neatness and cleanliness
b. State of repair, e.g. paint work, cracks
in floors, ceiling or walls, door seals,
etc?
c. Exposed piping or electrical wiring?
d. Blocking of air ducts?
e. Equipment blocking corridors or
exists?
2.0 B: Support Systems
# Audit Item Yes No NA Observations (indicate
N.O. if not observed)
1 Support systems, including those
identified below:
a. Are they designed and validated to
assure integrity of the characteristics of
in-process material and final products?
b. Is there a planned maintenance
program on each system?
Is it followed?
c. Are there specs and written procedures
for the operation of the systems,
sampling plan, sites monitored and alert
and action levels defined?
d. Are definitive action steps taken to
resolve conditions that are out of
specification?
2 HVAC system
a. Are pre-filters present in heating,
ventilation and air-conditioning
(HVAC) systems and replaced on a
routine basis?
h. Is the air flow adequate? (Minimal
pressure differential (1.21mm H2O)
maintained?
i. Is room temperature and humidity
effectively controlled?
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INSPECTION OF: Date:

2.0 B: Support Systems continued

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
3 Compressed Air
a. Is the air supply free from oil?
b. Is the air supply filtered
By suitable grade air filter?
c. Is humidity controlled?
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GMP AUDIT CHECKLIST (AS PER WHO GUIDELINES) Page 11 of 32

INSPECTION OF: Date:

3.0 A: Adequacy

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Is the equipment appropriately
designed, constructed and maintained?
2 Are steps taken to prevent any
substances required for operation, such
as lubricants or coolants, from coming
in contact with in-process or finished
products?
3 Are equipment surfaces that contact
components or products of a non-
interactive nature?
4 Are process pipelines or service lines
whose contents come in contact with
products or product contact surfaces
sloped to allow proper drainage?

3.0 B: Cleaning and Maintenance

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Is the equipment suitably located to
facilitate its use, cleaning and
maintenance?
2 Are filters used for filtration
integrity tested before and after use?
3 Are calibrations and validation being
performed adequately?
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INSPECTION OF: Date:

3.0 C: SOPs and Records

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are there written procedures (SOPs)
for cleaning and maintenance of
equipment and floors and they are
followed?
2 Do these SOPs include:
a. Assignment of responsibility for
cleaning?
b. Defined schedules for cleaning and
maintenance?
c. Description of methods, equipment and
materials used?
d Are there preventive maintenance
programs and consistent records of
work performed?
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3.0 D: Automated and Computerized Equipment and Systems

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 For automatic and computer-controlled
systems:
a. Is there an adequate description of the
system, the components, and the
operating characteristics including a
logic flow diagram?
b. Is there an individual with appropriate
expertise in charge?
c. Is there a procedure for on-going
evaluation and change control?
2 Are there manual overrides for
automated production equipment or
facility systems in case of failure?
3 Are the procedures in writing?
4 Are computer systems
controlled in order to prevent
unauthorized changes?
5 Are back-files of computerized data
created regularly and maintained?
6 Where computerization eliminates
calculations, is a written record of the
program filed with the validation data?
7 Are there alternative systems (hard
copy) designed and maintained to
ensure that back-up data are exact and
complete and is that system secured
from alteration, erasure or loss?
8 Validation of hardware and software:
a. Have all systems been validated?
b. Is validation performed in-house or on
contract?
If on contract, are records kept of the
qualifications of the contractor?
c. Are records maintained?
d. Has a risk assessment of each computer
system been made?
It is appropriate?
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4.0 A: Adequacy of starting materials

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are there approved specification for all
starting material or raw material used in
the manufacturing process and are they
released by Quality control?
2 To ensure the quality of raw materials:
a. Is there a quarantine and release
system?
b. Are the conditions of storage
evaluated?
c. Do the contracts with vendors ensure
quality and stability, including
reporting of changes in manufacture?
b. Are they stored in controlled
environments?
c. Are expiry dates given and is there a
retest policy?
d. Are rejected materials properly
segregated from acceptable material?
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4.0 B: Processes

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Master Formula (MF):
a. Does the MF adequately describe the
complete production process?
b. Is the MF up-to-date and approved by
QC/QA
c. Is the Batch Production Record form
and adequate representation of the MF?
2 Process validation:
a. Has each phase of the production
process been validated according to an
approved validation protocol?
b. Is re-validation done when required,
and performed appropriately?
c Are in-process intermediate materials
tested for identity, quality strength and
purity? Alternatively, are there valid
certificates of quality issued from the
suppliers?
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4.0 D: Identification

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 If a component/material is transferred
to a new container, is the new
contained identified with:
a. Component/material name or item
code?
b. Receiving or control number?
c. Amount in container?
2 Are dispensing/addition operations
adequately supervised in that each
component /material dispensed is
examined by a second person to ensure:
a. The component/material was released
by QC?
b. The amount agrees with the batch
record?
c. The container is properly identified?
d. The components/material are added in
the batch by one person and verified by
a second person?
3 Are actual yield and percentages of
theoretical yield determined at the
conclusion of each phase of operation
with documentation of any losses?
4 Are the yield calculations verified by a
second person?
5 Are all containers, lines and major
equipment identified at all times
production for content and phase of
operations?
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GMP AUDIT CHECKLIST Page 18 of 32

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5.0 A: Adequacy

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are specifications, standards, sampling
plans, test procedures or other
laboratory control mechanisms
including any revision, reviewed and
approved by Quality Assurance?
2 Are any deviations from these specs,
standards, etc. recorded and justified?
3 Do laboratory controls include the
establishment of scientifically sound
and appropriate specifications,
standards, sampling plans, test
procedures and reference substances,
designed to assure that tested materials
conform to appropriate standards of
identify, strength, quality and purity?
4 Do these laboratory controls include:
a. Determination of compliance with
written specifications for acceptance of
each lot within each shipment of
materials or holding or products?
b. Description of sampling and testing
procedures for in-process materials?
c. Retest policy, indentifying the rationale
and criteria for retests, number of
samples, and the documentation
required?
d. A comprehensive calibration program
that includes calibration/certification
intervals, acceptance criteria and
provisions for remedial action?
e Are there written sampling and testing
plans for raw materials, intermediates,
and final products that include method
of sampling and the number of units
per batch to be tested and are the
followed?
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5.0 C: Validation, Calibration and Stability Programme

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are the accuracy, sensitivity,
specificity and reproducibility of test
methods established, documented,
validated and subject to regular review
and updating?
2 Is there a written testing programme
designated to assess the stability
characteristics of each product to
determine the appropriate storage
conditions and expiration dates?
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6.0 A: General

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are there records for:
a. All materials used?
b. All standard operating procedures?
c. Each lot and/or batch processing and
distribution?
d. All complaints and their investigation?
e. All equipment, including cleaning,
maintenance and validation?
f. Cleaning, maintenance and
environmental control of the premises?
2 Are all records:
a. Dated?
b. Signed by the person performing the
task (and, for all critical steps, by the
person checking it)?
c. Kept at the workstation during the
entire operation?

6.0 B: Lot/Batch Processing Records (BPR)

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Does the BPR indicate:
a. The name, strength and dosage of the
product?
b. The date of manufacture?
c. The lot and batch identification no.?
d. Assurance that the copy of the master
processing record is accurate?
e. Changes in the master processing
record approved by QA prior to starting
the operation?
f. The complete formulation of the
lot/batch?
g. The batch number of each component
or other in-process materials and, when
applicable, the sterilization number?
h. The SOPs used?
i. The yield obtained a different stage of
manufacture, both actual measured
values and as a percentage of the
expectation?
j. A record of each step followed?
k. A record of all major equipment used?
l. A record of all in-process control
samples taken and of the results
obtained?
m. Identification of packaging materials,
containers, closures used?
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6.0 B: Lot/Batch Processing Records (BPR), contd….

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
r. For rejected lots/batches, a record of
disposal or reprocessing?
2 Are all batch processing records
reviewed and signed appropriately as
indicated by:
a. A BPR review document or checklist
describing the review process?
b. A dated signature of the person
responsible for approving the
manufacturing operations?
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7.0 A: Procurement

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are there SOPs for
procurement?
2 Is a specific individual in department,
authorized to order?
3 Do contracts with supplies assure the
quality and consistency of the order
provided?

7.0 B: Receipt and Evaluation

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are there SOPs covering the receipt of
part, including identification of the
responsible person and required
documentation?
2 Are the newly received part placed
in quarantine?
3 Are there SOPs for evaluating the
Quality status of parts prior to use?

7.0 C: Care

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are there SOPs covering
handling and care of the
parts?
2 Are there SOPs for identification and
isolation of any poor Quality
parts?
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7.0 E: Facilities

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are there enough rooms of
appropriate design to allow separate
housing of:
a. The Incoming parts ?
Different parts and products
b. ?
c. Parts in quarantine?
d. Rejected ?
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8.0 A: General

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are there records on suppliers,
contractors and consultants?
2 Are there records of their
qualifications?
3 Are there records on up-dating
documents?

8.0 B: SOPs

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are there SOPs written and approved
for all manufacturing and testing
activities?
2 Are the SOPs reviewed on a regular
and defined schedule? At least
annually?
3 Are revisions of SOPs approved by an
authorized person?
4 Is there a system for distribution of
SOPs and for revocation of outdated
SOPs?
5 Is it clear that SOPs are used and
followed in both production and QC?

8.0 C: Equipment

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Is there a system for validation and
regular revalidation of all equipment,
including revalidation after repairs?
2 Is there a system for calibration of all
instruments?
3 Is there a system to report, investigate
and record all deviations from
specifications or malfunctioning of
equipment?
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8.0 E: Intermediates and final product

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Is the stability of the final products and,
if applicable, of the intermediates
monitored?
2 Is there a quarantine and release system
for intermediates and final products,
including clear identification of the
status (Quarantine, released, rejected,
etc.)?
3 Is there a system for reprocessing of
unsatisfactory and returned products,
subject to prior approval by quality
control?
4 Is there a system for rapid evaluation
and investigation of complaints
received from the customer ?
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8.0 F: Quality Control

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Is the QC department independent from
production?
2 Are all QC tests validated?
3 Does the QC laboratory have SOPs
describing sampling, testing,
documentation and précised criteria for
release?
4 Is QC monitoring consistency of
production using trend analysis?
5 Is the QC Laboratory involved in all
decisions that may concern the quality
of the product?

8.0 G: Inspections

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Is there a system for regular self-
inspection of each manufacturing and
test area?
2 Are the inspections followed up to
ensure that appropriate action was
taken to correct deficiencies?
3 Is there a system for inspection of
contractors in respectof any
manufacturing or testing activities
contracted out?
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9.0 A: Packaging Materials

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Do primary and printed packaging
materials have specifications describing
qualitative And quantitative
requirements?
2 Are standard operating procedures for
the receipt, sampling and testing of
packaging materials available?
3 Are incoming materials stored in
controlled areas until released from
quarantine?
4 Are released materials secured in
controlled areas and is inventory
maintained?
5 Are control or reference numbers
assigned to each lot for traceability and
control purposes?
6 Are all label texts approved by the
control authority prior to use
and is there a master file of approved
labeling held by the responsible
person?
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9.0 B: Labeling and Packaging Operations

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are SOPs available for the labeling and
packaging operations for Tools
and material delivery to the floor and
are these easily accessible to the
operators?
2 Are labeling and packaging operations
properly physically segregated to
prevent mix-up of product or packaging
materials?
3 Is there an inspection of the line made
before and after each labeling and
packaging operation? Is it documented
and signed by the responsible person?
4 Is the name, strength and batch number
prominently displayed at each
operation?
5 Is there a segregated and secure
quarantine storage area for finished
goods awaiting QC release?
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9.0 C: Storage and Distribution

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
3 Do records show the date, quantity, and
mode of package and dispatch of each
lot/batch to the customer?
4 Are there standard operating
procedures for the storage of released
finished product to the dispatch area?
5 Are standard procedures available for
warehousing?
6 Are standard procedures available that
describe the shipping, final transit
conditions and instruction for storage
through the distribution chain,
especially the cold chain?
7 Are the shipping methods,
validated and routinely
monitored?
8 Are records detailed and retrievable so
that a rapid recall of any particular lot
is achievable? Is the recall process
delegated to the responsible person?
9 Are records maintained for 2 years after
the expiry dates?
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10.0 A: Facility design

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Is their air handling system capable of
maintaining the designed containment
level (e.g. are supply and exhaust
systems adequate for the level of
containment required)
2 Where applicable, are filters
installed in the exhaust system?
4 Is the air pressure in the manufacturing
area appropriate to the surrounding
areas?
5 Are the rooms designed to permit
satisfactory cleaning and
decontamination?
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10.0 C: Operational Practices and Procedures

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Are there standard operating
procedures for decontamination of
process equipment and facilities? Have
these procedures been validated and is
the performance monitored?
2 Is the equipment tested regularly for
integrity of containment capability?
3 Are standard operating procedures
available and displayed outlining
emergency procedures in the event of a
Emergency
4 Is there a list displayed of responsible
individuals to be contacted in the event
of an emergency?
5 Do personnel have specific training in
the procedures for handling the
Safety equipments
of using containment equipment?
6 Are there SOPs for dress codes
specified for containment levels
applicable and is access controlled and
secured? Is there a list displayed of
authorized staff for entry?
7 Are showers available where
applicable?
8 Is there a health and medical
surveillance program?
9 Are biohazard signs used and posted
where applicable?
10 Are SOPs available for the transport of
microorganisms in closed systems or
containers to and from the area?
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11.0 A: General

# Audit Item Yes No NA Observations (indicate

N.O. if not observed)
1 Pest control programme:
a. Is there a pest control programme? Is it
in writing and is it followed?
b. Are pesticides used?
c. Is their use controlled so as to avoid
product contamination?
d. Are there records of pesticide usage?
e. Is pesticide storage controlled?
f. Has QA approved the pesticides and
the programme?
2 Are sewage, refuse, trash controlled
and/or disposed of in a safe, timely and
sanitary manner?
3 Are adequately constructed waste
containers located in appropriate areas?
4 Are bagged/boxed items stored off the
floors and spaced to allow for cleaning
and proper identification?
5 Do written procedures for cleaning and
sanitation include:
a. Assignment of responsibility for
sanitation?
b. Details of cleaning schedules, methods,
equipment and material?
c. Routine evaluation of the effectiveness
of disinfectants and cleaning agents,
and chronological record of the agents
used?
d. Information to be recorded?
e. Validation for effectiveness of
cleaning/sanitation, and validation of
removal of residual cleaning/sanitizing
agents?
f. Are the procedures followed and are
records maintained?
6 Are equipment and chemicals used in
cleaning appropriately maintained and
stored?