GMP Audit check list

Sr. Checklist Available Remark

No. or not
Management Responsibility/QA
Are Quality Policy Available?
Is Quality Objective Available?
Are MR Appointment letters Available?
MRM
 Procedure Available?
 MRM Schedule of the year is available?
 Are MRM agenda available?
 Are written reports available for all MRM-Input &
Output?
Internal audit
 Procedure Available?
 Internal Audit Schedule of the year is available?
 Are Audit Plan
 Are written reports available for all Internal Audit?
 Are Corrective/preventive action implemented &
documented?
 Are all the non-conformance issues observations
closed properly?
Check any one of the completed Change control forms for all
the details.
Document & Data Control
How the documents are designed, prepared, reviewed and
controlled to provide an audit trail. Whether documents are
approved signed and dated by appropriate and authorized
person. Whether documents are approved signed and dated
by appropriate and authorized person. Whether documents
specify title, nature and purpose. Whether documents are
regularly reviewed and kept up to date. If yes. Please specify
review period. Please attached the list of documents
maintained by the firm
Whether data is recorded by electronic data processing
system or by other means. If by electronic data processing
system then how access is controlled to enter, modify etc. the
data.
Whether master formula and detailed operating procedures
are maintained as hard copy.
Who is responsible for the maintenance of these records.
Procedure/Master list of documents& Records
Documentation change control
Design Control
Design & Development File
Clinical evaluation Report
Risk analysis Report
Device master Record (DMR)
Check Device Master Record
How Device Master Records are prepared, authorized, and
controlled.
Site master file
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HR
Are Organization Charts Available?
Responsibility & authority (Job Description)?
Name, qualification, and experience of key personnel
(Competency matrix)
Training of personnel
Are written programs for training available (Training Calander)
Training record (Select any 2-3 employees)
Induction training record (select any 2 employees)
SOP for training of personnel
Personnel hygiene
Whether all personnel prior to employment have undergone
medical examination including eye examination and all free
from Tuberculosis, skin and other communicable or
contagious diseases.
(Medical examination report)
Whether there is a SOP for medical examination.
Pls give name and qualification of contracted medical officer
for medical examination.
SOP for clothing & hygiene
Whether proper uniforms and adequate facilities for personal
cleanliness are provided. Pls specify nature and type of dress
used by the personnel in various areas of operation.
How many dress/footwears have been provided to each
personnel. Please specify whether cross over bench is in
place in the change room and if so whether it rule out the
possibility of entering dust particle to the clean side. Whether
arrangements provided for cleaning of outside dust and dirt
from foot Please specify whether hands are disinfected before
entering the production area Whether for sterile garments in
house clean laundry has been provided.
Purchasing control
Procedure for purchase
Approved supplier list
Agreements
PO
Quality Control: -
Whether QC area is independent of production area. Whether
QC carries out its own:
 physico-chemical testing,
 biological testing,
 microbiological testing & sterility testing and
 Instrumental testing. Whether firm is outsourcing
testing.
If yes names of the testing laboratories contacted or
approved. Pls give list of tests currently outsourced. In case of
contractual testing what are the responsibilities of contract
giver and contract acceptor. (Copy of the contract should be
enclosed) SOP No.: EP-INS-004 Page 8Are there safety
installation such as shower, eye washer, fire extinguisher etc
in the laboratory. Is there separate area for humidity chambers
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for stability studies. How many humidity chambers have been

provided. Pls attach stability calendar.
Please specify the arrangement provided for handling and
storage of test samples, retained samples, reference
standards / cultures, reagents. Whether retained samples are
stored for a period of 1 year after expiry or 3 years after
distribution whichever is earlier? Whether separate area for
storage of reagents and glassware provided. Whether
separate records room is provided
How hazardous or poisonous materials are stored and
handled.
How environmental conditions are met during the course of
storage and testing of samples.
Which grade of glassware are used in assay procedures.
Whether separate AHU's are provided for biological,
microbiological and radio iso-topes testing areas with HEPA
filter arrangement).
Whether separate areas are provided for sterility testing within
microbiology lab. Whether support areas are under AHU.
Whether double door autoclave provided for the sterilization of
materials
Whether entry to the sterility area is through three airlock
systems. What is the air class of these testing areas and
whether pressure difference is maintained in these areas?
How waste (cultures etc) is disposed of. Whether in the case
of antibiotic potency testing, statistical proof of the
determination of potency and validity of the test is carried out.
Please specify the sampling procedures from various stages
of production.
How it is ensured that the sample collected is representative
of the whole batch. (Sampling register)
Please specify the procedures for carrying out the stability
studies.
Please attach the stability calendar of last year.
Whether records of stability studies are maintained
Under what conditions stability studies of the products are
tested? How many stability chambers have been provided.
How validation procedures are documented (Please indicate
various protocols/ recoding system applied during validation).
Whether specifications for raw materials intermediates final
products and packaging materials are available
Monitoring and measurement of equipment (calibration
record)
­ Does the facility have approved written procedures for
checking and calibration of each piece of
measurement equipment?
Are records of calibration checks and inspections maintained
in a readily retrievable manner?
Whether balances and other measuring equipment with
appropriate range are available in the Raw Material stores &
production areas and they are calibrated in accordance with
SOP maintained. Specify the calibration schedule of
the balances.
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Production & process controls

Whether the contents of all vessels and containers used in
manufacture and storage are conspicuously labelled with the
name of the products. Batch no, Batch Size, and stage of
manufacture along with the signature of technical staff.
Precautions against mix-up and cross-contamination: -
Whether proper AHU, pressure differential, segregation, and
status labelling have been provided to prevent mix-up and
cross-contamination in manufacturing area
Do all the areas have their own independent air locks
separately for men and material entry.
Whether various operations are carried out in segregated
areas
How line clearance is performed. Whether records of line
clearance is maintained according to appropriate checklist
Whether separate coding area has been provided or online
coding is performed How coding procedure is controlled.
Follow Entry-exit/gowning De gowning procedure
Batch Manufacturing record
How BMR are designed to avoid transcription errors. Whether
the Batch Processing Records for each product on the basis
of currently approved master formula is being maintained.
Whether following information are recorded in BMR (a) the
name of the product, (b) the number of the batch being
manufactured, (c) dates and time of commencement,
significant intermediate stages and completion of production.
(d) initials of the operator of different significant steps of
production and where appropriate, of the person who checked
each of these operations, (e) the batch number and/or
analytical control number as well as the quantities of each
starting material actually weighed, (f) any relevant processing
operation or event and major equipment used, (g) a record of
the in-process controls and the initials of the person(s)
carrying them out, .0and the results obtained, (h) the amount
of product obtained after different and critical stages of
manufacture (yield), (i) comments or explanations for
significant deviations from the expected yield limits shall be
given, (j) notes on special problems including details, with
signed authorization, for any deviation from the Master
Formula, (k) Addition of any recovered or reprocessed
material with reference to recovery or reprocessing stages.
Specify the procedures for all the entries made in BMR‟s.
Who releases batch of the products for sale
Finished Product Control
Do written procedures indicate how and who verifies that
correct containers and packages are used for finished product
during the finishing operation?
Are expiration dates related to any storage conditions stated
on the label?
Are all finished products held in quarantine until QC has
completed its testing and releases product on a batch to batch
basis for sale?
Is finished product stored under appropriate conditions of
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temperature, humidity, light, etc.

Are written sampling and testing procedures and acceptance
criteria available for each product to ensure conformance to
finished product specifications?
Are sterility testing performed as required?
How to handle of Nonconforming Product
Product Recalls: -
Recall / Return goods
Whether segregated secured areas for recall or rejected
materials or for such material which are to be processed or
recovered are provided. Please specify the room No. of such
areas in the plant.
Specify the product recall system followed by the firm. How
promptly recall operation at the level of each distribution
channel up-to the retail level can be carried out. Whether
there is a SOP for recall of products clearly defining
responsibility, procedure, reporting, re-conciliation etc
Validation and Process Validation: -
Specify the validation policy of the company. Whether
validation master plan has been prepared.
Whether validation studies of processing, testing and cleaning
procedures are conducted as per pre defined protocol.
How records and conclusion of such validation studies are
prepared and maintained.
Whether DQ,IQ,OQ & PQ are in place for all major equipment
and facility
Whether validation records of all utilities and major
equipment’s are available.
Environment control
­ Is adequate ventilation provided?
­ Is control of air pressure, dust, humidity and
temperature adequate for the manufacture,
processing, storage or testing of drug products?
­ Does this facility have written procedures for the safe
use of suitable, (e.g. those that are properly
registered) rodenticides, insecticides, fungicides, and
fumigating agents?’
­ Is this facility maintained in a clean and sanitary
condition?
Incoming material :
Please specify the procedures followed receiving and
processing of in-coming materials (Starting materials and
packing material).
Whether first in / first out or first expiry principal has been
adopted.
How they are labeled and stored as per their status – Under
Test, Approved and Rejected
Whether incoming materials are purchased from approved
sources.
Whether list of approved vendors is available to the user
How damaged containers are identified recorded and
segregated
Whether labels of Incoming material in the storage area have
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information like
(a) designated name of the product and the internal code
reference, where applicable, and analytical reference number;
(b) manufacturer ‘s name, address and batch number;
(c) the status of the contents (e.g. quarantine, under test,
released, approved, rejected); and
(d) the manufacturing date, expiry date and re-test date.
Does the facility have current written procedures for
acceptance/rejections of materials , containers, closures,
labeling and packaging materials?
Does inspection start with visual examination of each shipping
container for appropriate labeling, signs of damage, or
contamination?
Is the sampling technique written and followed for each type
of sample collected?
Whether separate areas are provided for under test, approved
and rejected materials.
How control on temperature and humidity conditions,
wherever necessary, maintained in these storage areas.
How materials are stacked in the Stores i.e on Pallets, racks
etc
How printed packaging materials, product leaflets etc. are
stored separately to avoid chances of mix- up
How records of receipt of all labeling and packaging materials
are maintained.
Whether re-conciliation of used packaging materials is
maintained. Whether unused packaging materials return to
the store or destroyed.
How returned/unused packaging material like foils is
controlled so as to prevent contamination and cross-
contamination.
At least one test is conducted to confirm the identity of a raw
material (bulk chemical or pharmaceutical) when a Certificate
of Analysis is provided by supplier and accepted by QA.
If a Certificate of Analysis is not accepted for a lot of material,
then additional testing is conducted by a written protocol to
determine suitability for purpose.
Microbiological testing is conducted where appropriate.
Material Component Storage and Handling
(Verify that materials and components are stored and handled
in a way that prevents contamination, mix-ups, and errors.)
Are incoming materials and components quarantined until
approved for use?
Are all materials handled in such a way as to prevent
contamination?
Are all materials stored off the floor?
Are materials spaced to allow for cleaning and inspection?
Are labels for different products, stored separately with
suitable identification?
Is label storage area limited to authorized personnel?
Are rejected components, material, and containers
quarantined and clearly marked to prevent their use?
Does a written procedure specify who is authorized to issue
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labels?
Complaint Handling and Customer Satisfaction Program
Are complaints, whether received in oral or written form,
documented in writing and retained in a designated file?
Are complaints reviewed on a timely basis by the Quality
Control Unit?
Is the action taken in response to each complaint
documented?
Are decisions not to investigate a complaint also documented
and the name of the responsible person documented?
Are complaint investigations documented and do they include
investigation steps, findings, and follow-up steps, if required?
Are dates included for each entry?
Corrective Preventive action report