GMP Audit Checklist

Audit Checklist 1

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
1.0 General Controls
Does the facility and its many departments
(organizational units) operate in a state of
control as defined by the GMP regulations?
Organizational & Management
1.1
Responsibilities
Does this facility/business unit operate under
1.101
a facility or corporate quality policy?
§211.22(a) Does a Quality Assurance unit
1.102 (department) exist as a separate
organizational entity?
§211.22(a) Does the Quality Assurance
unit alone have both the authority and
responsibility to approve or reject all
1.103
components, drug product containers and
closures, in-process materials, packaging
materials, labeling and drug products?
§211.22 Does the QA department or unit
routinely review production records to ensure
1.104
that procedures were followed and properly
documented?
§211.22(b) Are adequate laboratory space,
1.105 equipment, and qualified personnel available
for required testing?
1.106 If any portion of testing is performed by a
contractor, has the Quality Assurance unit
inspected the contractor's site and verified
that the laboratory space, equipment,
qualified personnel and procedures are
Audit Checklist 1

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
adequate?
Date of last
1.107
inspection:____________________
1.108 §211.22(c) Are all QA procedures in writing?
§211.22(c) Are all QA responsibilities in
1.109
writing?
Are all written QA procedures current and
1.110
approved? (Review log of procedures)
Are the procedures followed? (Examine
1.111 records to ensure consistent record-keeping
that adequately documents testing.)
§211.25 Are QA supervisory personnel
1.112
qualified by way of training and experience?
§211.25 Are other QA personnel, e.g.,
1.113 chemists, analysts, laboratory technicians)
qualified by way of training and experience?
§211.22(a) Does the QA unit have a person
or department specifically charged with the
1.201 responsibility of designing, revising, and
obtaining approval for production and testing
procedures, forms, and records?
§211.22(d) Does a written SOP, which
identifies how the form is to be completed and
1.202
who signs and countersigns, exist for each
record or form?
§211.165(a)(b)(c) Is the production batch
record and release test results reviewed for
1.203
accuracy and completeness before a batch/lot
of finished product is released?
Employee Orientation, Quality Awareness,
1.3
and Job Training
1.301 Circle the types of orientation provided to
Audit Checklist 1

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
each new employee: (1) Company brochure
(2) Literature describing GMP regulations and
stressing importance of following instructions.
(3) On-the-job training for each function to be
performed (before the employee is allowed to
perform such tasks). (4) Other: enter in
notebook.
§211.25(a) Does each employee receive
1.302 retraining on an SOP (procedures) if critical
changes have been made in the procedure?
Indicate how on-going, periodic GMP training
1.303
is accomplished.
§211.25 is all training documented in writing
that indicates the date of the training, the type
1.304
of training, and the signature of both the
employee and the trainer?
§211.25 Are training records readily
retrievable in a manner that enables one to
determine what training an employee has
1.305
received, which employees have been trained
on a particular procedure, or have attended a
particular training program?
Are GMP trainers qualified through
1.306
experience and training?
§211.25(a) Are supervisory personnel
instructed to prohibit any employee who,
because of any physical condition (as
determined by medical examination or
1.307 supervisory observation) that may adversely
affect the safety or quality of drug products,
from coming into direct contact with any drug
component or immediate containers for
finished product?
Audit Checklist 1

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
§211.28(d) Are employees required to report
to supervisory personnel any health or
1.308
physical condition that may have an adverse
effect on drug product safety and purity?
§211.25(a) Are temporary employees given
1.309 the same orientation as permanent
employees?
§211.34 Are consultants, who are hired to
advise on any aspect of manufacture,
processing, packing or holding, of approval
1.310
for release of drug products, asked to provide
evidence of their education, training, and
experience?
§211.34 Are written records maintained
stating the name, address, qualifications, and
1.311
date of service for any consultants and the
type of service they provide?
1.4 Plant Safety and Security
Does this facility have a facility or corporate
1.401
safety program?
1.402 Are safety procedures written?
1.403 Are safety procedures current?
Do employees receive safety
1.404
orientation before working in the plant area?
Is safety training documented in a readily
retrievable manner that states the name of
the employee, the type of training, the date of
1.405
the training, and the name of the trainer and
the signature of the trainer and the
participant?
Does this facility have a formal, written
1.406
security policy?
Audit Checklist 1

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
1.407 Is access to the facility restricted?
1.408 Describe how entry is monitored/restricted:
Is a security person available 24 hours per
1.409
day?
1.5 Internal Quality/GMP Audit Program
Does this business unit/facility have a written
1.501
quality policy?
Is a copy of this quality policy furnished to all
1.502
employees?
If "yes" to above, when provided?
1.503
__________________
1.504 Is training provided in quality improvement?
Does a formal auditing function exist in the
1.505
Quality Assurance department?
Does a written SOP specify who shall conduct
audits and qualifications (education, training,
1.506
and experience) for those who conduct
audits?
Does a written SOP specify the scope and
1.507 frequency of audits and how such audits are
to be documented?
Does a written SOP specify the distribution of
1.508
the audit report?
1.6 Quality Cost Program
Does this facility have a periodic and formal
1.601
review of the cost of quality?
Does this facility have the ability, through
1.602 personnel, software, and accounting records,
to identify and capture quality costs?
Does this facility make a conscious effort to
1.603
reduce quality costs?
Audit Checklist 2

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
2.0 Design Control
Not directly related to 21 CFR Parts 210 and
211
Audit Checklist 3

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
3.0 Facility Control

3.1 Facility Design and Layout

§211.42(a) Are all parts of the facility
constructed in a way that makes them
3.101
suitable for the manufacture, testing, and
holding of drug products?
§211.42(b) Is there sufficient space in the
3.102 facility for the type of work and typical volume
of production?
Does the layout and organization of the
3.103
facility prevent contamination?
3.2 Environmental Control Program
The facility is NOT situated in a location that
3.201 potentially subjects workers or product to
particulate matter, fumes, or infestations?
3.202 Are grounds free of standing water?
3.203 §211.44 Is lighting adequate in all areas?
3.204 §211.46 Is adequate ventilation provided?
§211.46 Is control of air pressure, dust,
humidity and temperature adequate for the
3.205
manufacture, processing, storage or testing of
drug products?
Audit Checklist 3

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
§211.46 If air filters are used, is there a
3.206 written procedure specifying the frequency of
inspection and replacement?
Are drains and routine cleaning procedures
3.207 sufficient to prevent standing water inside the
facility?
§211.42(d) Does the facility have separate air
handling systems, if required, to prevent
3.208
contamination? (MANDATORY IF
PENICILLIN IS PRESENT!)
Facility Maintenance and Good
3.3
Housekeeping Program
§211.56(a) Is this facility free from infestation
3.301
by rodents, birds, insects and vermin?
§211.56(c) Does this facility have written
procedures for the safe use of suitable, (e.g.
3.302 those that are properly registered)
rodenticides, insecticides, fungicides, and
fumigating agents?
Is this facility maintained in a clean and
3.303
sanitary condition?
Does this facility have written procedures that
3.304 describe in sufficient detail the cleaning
schedule, methods, equipment and material?
Does this facility have written procedures for
3.305 the safe and correct use of cleaning and
sanitizing agents?
§211.58 Are all parts of the facility maintained
3.306
in a good state of repair?
§211.52 Is sewage, trash and other refuse
3.307 disposed of in a safe and sanitary manner
(and with sufficient frequency?)
Audit Checklist 3

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
3.4 Outside Contractor Control Program
§211.56(d) Are contractors and temporary
3.401 employees required to perform their work
under sanitary conditions?
§163 Are contractors qualified by experience
or training to perform tasks that may influence
3.402
the production, packaging, or holding of drug
products?
Audit Checklist 4

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
4.0 Equipment Control
4.1 Equipment Design and Placement
§211.63 Is all equipment used to
manufacture, process or hold a drug product
4.101
of appropriate design and size for its intended
use?
Are the following pieces of equipment suitable
for their purpose? Blender(s), Conveyor(s),
4.102
Tablet, Presses, Capsule Fillers, Bottle
Fillers, Other (specify).
Are the following pieces of equipment suitable
in their size/capacity? Blender(s),
4.103
Conveyor(s), Tablet, Presses, Capsule Fillers,
Bottle Fillers, Other (specify).
Are the following pieces of equipment suitable
in their design? Blender(s), Conveyor(s),
4.104
Tablet, Presses, Capsule Fillers, Bottle
Fillers, Other (specify).
Audit Checklist 4

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
Are the locations in the facility of the following
pieces of equipment acceptable? Blender(s),
4.105
Conveyor(s), Tablet, Presses, Capsule Fillers,
Bottle Fillers, Other (specify).
Are the following pieces of equipment
properly installed? Blender(s), Conveyor(s),
4.106
Tablet, Presses, Capsule Fillers, Bottle
Fillers, Other (specify).
Is there adequate space for the following
pieces of equipment? Blender(s),
4.107
Conveyor(s), Tablet, Presses, Capsule Fillers,
Bottle Fillers, Other (specify).
§211.65(a) Are machine surfaces that contact
materials or finished goods non-reactive, non-
4.108
absorptive, and non-additive so as not to
affect the product?
§211.65(b) Are design and operating
precautions taken to ensure that lubricants or
4.109 coolants or other operating substances do
NOT come into contact with drug components
or finished product?
§211.72 Fiber-releasing filters are NOT used
4.110
in the production of injectable products?
§ 211.72 Asbestos filters are NOT used in the
4.111
production of products?
Is each idle piece of equipment clearly
4.112 marked "needs cleaning" or "cleaned; ready
for service"?
4.113 Is equipment cleaned promptly after use?
Is idle equipment stored in a designated
4.114
area?
4.115 §211.67(a)(b) Are written procedures
Audit Checklist 4

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
available for each piece of equipment used in
the manufacturing, processing or holding of
components, in-process material or finished
product?
Do cleaning instructions include disassembly
and drainage procedure, if required, to ensure
4.116
that no cleaning solution or rinse remains in
the equipment?
Does the cleaning procedure or startup
4.117 procedure ensure that the equipment is
systematically and thoroughly cleaned?
4.2 Equipment Identification
§211.105 Are all pieces of equipment clearly
4.201
identified with easily visible markings?
§211.105(b) Are all pieces of equipment also
marked with an identification number that
4.202
corresponds with an entry in an equipment
log?
Does each piece of equipment have written
4.203 instructions for maintenance that includes a
schedule for maintenance?
Is the maintenance log for each piece of
4.204
equipment kept on or near the equipment?
4.3 Equipment Maintenance & Cleaning
§211.67(b) Are written procedures
4.301 established for the cleaning and maintenance
of equipment and utensils?
4.302 Are these procedures followed?
§211.67(b)(1) Does a written procedure
4.303 assign responsibility for the cleaning and
maintenance of equipment?
4.304 §211.67(b)(2) Has a written schedule been
Audit Checklist 4

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
established and is it followed for the
maintenance and cleaning of equipment?
Has the cleaning procedure been properly
4.305
validated?
4.306 §211.67(b)(2) If appropriate, is the equipment
sanitized using a procedure written for this
task?
§211.67(b)(3) Has a sufficiently detailed
cleaning and maintenance procedure been
written for each different piece of equipment
4.307
to identify any necessary disassembly and
reassembly required to provide cleaning and
maintenance?
§211.67(b)(3) Does the procedure specify the
removal or obliteration of production batch
4.308
information from each piece of equipment
during its cleaning?
4.309 Is equipment cleaned promptly after use?
4.310 Is clean equipment clearly identified as
"clean" with a cleaning date shown on the
equipment?
§211.67(b)(5) Is clean equipment adequately
4.311
protected against contamination prior to use?
§211.67(b) Is equipment inspected
4.312
immediately prior to use?
§211.67(c) Are written records maintained on
equipment cleaning, sanitizing and
4.313
maintenance on or near each piece of
equipment?
Measurement Equipment Calibration
4.4
Program
4.401 §211.68(a) Does the facility have approved
Audit Checklist 4

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
written procedures for checking and
calibration of each piece of measurement
equipment? (Verify procedure and log for
each piece of equipment and note exceptions
in notebook with cross reference.)
§211.68(a) Are records of calibration checks
4.402 and inspections maintained in a readily
retrievable manner?
4.5 Equipment Qualification Program
§211.63 Verify that all pieces of equipment
used in production, packaging, and quality
4.501
assurance are capable of producing valid
results.
§211.68(a) When computers are used to
4.502 automate production or quality testing, have
the computer and software been validated?
Have on-site tests of successive production
4.503
runs or tests been used to qualify equipment?
Were tests repeated a sufficient number of
4.504
times to ensure reliable results?
§211.63 Is each piece of equipment identified
to its minimum and maximum capacities and
4.505
minimum and maximum operating speeds for
valid results?
Have performance characteristics been
identified for each piece of equipment? (May
4.506
be provided by the manufacturer, but must be
verified under typical operations conditions.)
Have operating limits and tolerances for
4.507 performance been established from
performance characteristics?
Audit Checklist 5

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
5.0 Material/Component Control
Material/Component Specification and
5.1
Purchasing Control
Although purchasing is not specifically
addressed in the current GMP regulation,
incumbent upon user of components and
materials to ensure quality of product,
material or component.
Has each supplier/vendor of material or
component been inspected/audited for proper
5.101 manufacturing controls? (Review suppliers
and audits and enter names, material
supplied, and date last audited in notebook.)
Material/Component Receipt, Inspection,
5.2
Sampling, and Laboratory Testing
§211.80(a) Does the facility have current
written procedures for acceptance/rejections
of drug products, containers, closures,
5.201
labeling and packaging materials? (List
selected materials and components in
notebook and verify procedures.)
§211.80(d) Is each lot within each shipment
of material or components assigned a
5.202 distinctive code so material or component can
be traced through manufacturing and
distribution?
§211.82(a) Does inspection start with visual
examination of each shipping container for
5.203
appropriate labeling, signs of damage, or
contamination?
5.204 §211.82(b) Is the number of representative
samples taken from a container or lot based
on statistical criteria and experience with each
Audit Checklist 5

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
type of material or component?
§211.160(b) Is the sampling technique
5.205 written and followed for each type of sample
collected?
Is the quantity of sample collected sufficient
5.206 for analysis and reserve in case retesting or
verification is required?
Verify that the following steps are included in
written procedures unless more specific
procedures are followed:
§211.84(c)(2) Containers are cleaned before
5.207
samples are removed.
§211.84(c)(4) Stratified samples are not
5.208
composited for analysis.
§211.84(c)(5) Containers from which
samples have been taken are so marked
5.209
indicating date and approximate amount
taken.
Each sample container is clearly identified by
material or component name, lot number,
5.210
date sample taken, name of person taking
sample, and original container identification.
§211.84(d)(1)(2) At least one test is
conducted to confirm the identity of a raw
5.211 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
5.212
conducted by a written protocol to determine
suitability for purpose.
5.213 §211.84(d)(6) Microbiological testing is
Audit Checklist 5

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
conducted where appropriate.
5.3 Material Component Storage and Handling
(Verify that materials and components are
stored and handled in a way that prevents
contamination, mixups, and errors.)
§211.42(b) Are incoming material and
5.301 components quarantined until approved for
use?
Are all materials handled in such a way to
5.302
prevent contamination?
5.303 Are all materials stored off the floor?
Are materials spaced to allow for cleaning
5.304
and inspection?
§211.122(d) Are labels for different products,
5.305 strengths, dosage forms, etc., stored
separately with suitable identification?
Is label storage area limited to authorized
5.306
personnel?
§211.89 Are rejected components, material,
5.307 and containers quarantined and clearly
marked to prevent their use?
5.4 Inventory Control Program
§211.142 Are inventory control procedures
5.401
written?
Does the program identify destruction dates
5.402 for obsolete or out-dated materials,
components, and packaging materials?
§211.150(a) Is stock rotated to ensure that
5.403 the oldest approved product or material is
used first?
5.404 §211.184(e) Is destruction of materials
documented in a way that clearly identifies
Audit Checklist 5

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
the material destroyed and the date on which
destruction took place?
5.5 Vendor (Supplier) Control Program
Are vendors periodically inspected according
5.501
to a written procedure?
Is the procedure for confirming vendor test
5.502
results written and followed?
Audit Checklist 6

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
6.0 Operational Control
Material/Component/Label Verification,
6.1
Storage, and Handling
§211.87 Do written procedures identify
storage time beyond which components,
6.101
containers, and closures must be reexamined
before use?
§211.87 Is release of retested material
6.102
clearly identified for use?
Are retesting information supplements
6.103
originally obtained?
Do written procedures identify steps in the
6.104
dispensing of material for production?
Do these procedures include (1) release by
QC, (2)Documentation of correct weight or
6.105
measure, and (3) Proper identification of
containers?
6.106 Does a second person observe
weighing/measuring/dispensing and verify
Audit Checklist 6

Instructions/Questions
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notebook
accuracy with a second signature?
§211.101(c) Is the addition of each
6.107 component documented by the person adding
the material during manufacturing?
§211.101(d) Does a second person observe
6.108 each addition of material and document
verification with a second signature?
§211.125(a) Does a written procedure specify
6.109
who is authorized to issue labels?
§211.125(a) Does a written procedure specify
how labels are issued, used, reconciled with
6.110 production, returned when unused, and the
specific steps for evaluation of any
discrepancies?
§211.125(d) Do written procedures call for
destruction of excess labeling on which lot or
6.111
control numbers have been stamped or
imprinted?
Equipment/Line/Area Cleaning,
6.2
Preparation, and Clearance
§211.67(b)(5) Do written procedures detail
how equipment is to be checked immediately
6.201 prior to use for cleanliness, removal of any
labels and labeling from prior print
operations?
§211.67(b)(3) Do written procedures detail
6.202 any disconnection and reassembly required to
verify readiness for use?
Operational Process Validation and
6.3
Production Change Order Control
6.301 Have production procedures been validated?
(Review selected procedures for validation
Audit Checklist 6

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
documentation. Adequate?)
§211.100(a) Does the process control
6.302 address all issues to ensure identity, strength,
quality and purity of product?
§§211.101(a) Does the procedure include
formulation that is written to yield not less
6.303
than 100% of established amount of active
ingredients?
§211.101(c) Are all weighing and measuring
6.304 preformed by one qualified person and
observed by a second person?
§211.101(d) Have records indicated
6.305 preceding policy been followed by presence
of two signatures?
§211.103 Are actual yields calculated at the
6.306 conclusion of appropriate phases of the
operation and at the end of the process?
§211.103 Are calculations performed by one
6.307 person? Is there independent verification by
a second person?
In-Process Inspection, Sampling, and
6.4
Laboratory Control
§211.110(a) Are written procedures
established to monitor output and validate the
performance of manufacturing procedures
6.401
that may cause variability in characteristics of
in-process materials and finished drug
products?
§211.110(c) Are in-process materials tested
at appropriate phases for identity, strength,
6.402
quality, purity and are they approved or
rejected by Quality Control?
Audit Checklist 6

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
§211.160(b) Are there laboratory controls
including sampling and testing procedures to
6.403 assure conformance of components,
containers, closures, in-process materials,
and finished product specifications?
6.5 Reprocessing/Disposition of Materials
§211.115(a) Do written procedures identify
6.501
steps for reprocessing batches?
§211.115(b) Are quality control review and
6.502 approval required for any and all reprocessing
of material?
Does testing confirm that reprocessed
6.503
batches conform to established specification?
Does a written procedure outline steps
required to reprocess returned drug products
6.504 (if it can be determined that such products
have not been subjected to improper storage
conditions?)
Does Quality Control review such
reprocessed returned goods and test such
6.505
material for conformance to specifications
before releasing such material for resale?
Audit Checklist 7

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
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7.0 Finished Product Control
Finished Product Verification, Storage,
7.1
and Handling
7.101 §211.30 Do written procedures indicate how
Audit Checklist 7

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
and who verifies that correct containers and
packages are used for finished product during
the finishing operation?
§211.134(a) In addition, do written
procedures require that representative
7.102 sample of units be visually examined upon
completion of packaging to verify correct
labeling?
§211.137(a) Are expiration dates stamped or
7.103
imprinted on labels?
§211.137(b) Are expiration dates related to
7.104
any storage conditions stated on the label?
§211.142(a) Are all finished products held in
quarantine until QC has completed its testing
7.105
and releases product on a batch to batch
basis for sale?
§211.142(o) Is finished product stored under
7.106 appropriate conditions of temperature,
humidity, light, etc.
Finished Product Inspection, Sampling,
7.2
Testing, and Release for Distribution
§211.166 Has the formulation for each
product been tested for stability based on a
7.201
written protocol? (Containers must duplicate
those used in final product packaging.)
§211.166 Are written sampling and testing
procedures and acceptance criteria available
7.202
for each product to ensure conformance to
finished product specifications?
7.203 §211.170(a) Is a quantity of samples equal to
at least twice the quantity needed for finished
product release testing maintained as a
Audit Checklist 7

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
reserve sample?
§211.167(a) Are sterility and pyrogen testing
7.204
performed as required?
§211.167(b) Are specific tests for foreign
7.205 particles or abrasives included for any
ophthalmic ointments?
§211.167(c) Do controlled release or
sustained release products include tests to
7.206
determine conformance to release time
specification?
7.3 Distribution Controls
§211.150(a) Does a written procedure
7.301 manage stocks to ensure that oldest
approved product is sold first?
§211.150(a) Are deviations to the policy
7.302
above documented?
§211.150(a) Does a written procedure
7.303 identify the steps required if a product recall is
necessary?
7.304 Is the recall policy current and adequate?
7.4 Marketing Controls
The current regulation does not address
marketing controls per se except that all
7.401
finished products must meet their
specifications.
Complaint Handling and Customer
7.5
Satisfaction Program
§211.198(a) Are complaints, whether
7.501 received in oral or written form, documented
in writing and retained in a designated file?
§211.198(a) Are complaints reviewed on a
7.502
timely basis by the Quality Control Unit?
Audit Checklist 7

Instructions/Questions
Question Note any exceptions and comments in Yes/No/NA
notebook
§211.198(b)(1) Is the action taken in
7.503
response to each complaint documented?
§211.198(b)(3) Are decisions not to
investigate a complaint also documented and
7.504
the name of the responsible person
documented?
§211.198(b)(2) Are complaint investigations
documented and do they include investigation
7.505
steps, findings, and follow-up steps, if
required? Are dates included for each entry?