Issued by: QA Date: 00-00-00 Revision: A QF-82-02-3

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Requirements What to look for and how Auditor notes and evidence
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Audit Checklist Examples

4 Quality Management System
4.1 General requirements
4.1 Is the quality management system Are processes needed for the quality management
820.5 documented, implemented and system identified and established (process map)? Is
maintained in accordance with the sequence and interaction between these
processes determined (process map)? Are criteria
requirements of ISO 13485 and CFR 21
and methods for the operation and control of
Part 820?
quality system processes established (operational
procedures)? Are required resources available? Are
quality system processes monitored and measured
(internal audit, customer feedback, manufacturing
process performance, etc.)?

4.1 Are outsourced processes adequately How are outsourced processes controlled? Are
controlled? outputs of outsourced processes verified? Are
subcontractors and suppliers required to operate
and maintain quality management systems (ISO
9001, for example)?

4.2 Documentation requirements

4.2.1 General
4.2.1 Are the following types of documents Are quality policy and quality objectives

Additional Notes:
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820.20(e) established, maintained and controlled: documented? Where?

quality policy and quality objectives; Is there a quality manual? Operational procedures?
quality manual;
Are drawings, specifications, work instructions,
operational procedures;
work orders, control plans, etc., issued and
device specifications including maintained as controlled documents (as required
drawings, composition, formulation, in 4.2.3)?
components, software etc. (Device
Are electronic documents (computer files) backed
Master Record); up?
production process specifications
including equipment, production
methods and procedures, operator
(work) instructions, production
environment specifications, etc.
(Device Master Record);
quality assurance procedures and
specifications including control plans,
inspection equipment and procedures,
acceptance criteria, etc. (Device Master
Record);
packaging and labeling specifications,
including methods and processes used
(Device Master Record);
installation, maintenance and servicing

Additional Notes:
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procedures and methods (Device

Master Record);
other documents needed to ensure the
effective planning and operation of the
quality system; and
Records (ref to ISO 13485 4.2.4)?

4.2.2 Quality manual

4.2.2 Does the quality manual include: Is the quality manual addressing all relevant
820.20(e) the scope of the quality management requirements of ISO 13485 and CFR 21 Part 820?
system and exclusions, Are exclusions from Section 7, Product Realization,
documented in the quality manual (if any)? Are
operational procedures or references
operational procedures included or referenced in
to them,
the quality manual? How is the interaction
description of the interaction between between the processes of the quality system
the processes of the quality system, documented (process map, flowcharts, etc.)? How
and is the structure of the quality system
Outline of the structure of the quality documentation outlined in the manual?
system documentation?

4.2.3 Control of documents

4.2.3 Is there a written procedure defining the Is there a written procedure for control of
820.40(a) controls needed to documents? Are controlled documents reviewed
review and approve documents prior to and approved? How is the approval evidenced

Additional Notes:
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issue, (signature)? Is there a process for reviewing,

review, update and re-approved updating and re-approving documents? Are
documents, documents identified with their revision level? How
are changes identified (change brief, highlighted,
identify changes and current revisions
etc.?) What measures are implemented to ensure
of documents,
that relevant and current documents are available
make relevant and current documents at points of use (distribution lists, current master
available at points of use, lists, etc.)? Are documents uniquely identified
ensure that documents are legible and (unique title and /or code-number) and are they
identifiable, legible? Is there a process for receiving, reviewing,
identify and control the distribution of approving (for use) and distributing documents of
documents of external origin, and external origin (form customers, regulators,
identify retained obsolete documents suppliers, etc.) When obsolete documents are
retained, is it for a specific, stated reason? Are
and prevent their unintended use?
obsolete documents clearly marked to distinguish
Is the procedure fully implemented? them from current revisions? What other measures
are implemented to prevent unintended use of
obsolete documents?

4.2.3 Is the period for retention of obsolete Is a retention period defined for each type of
controlled documents defined? controlled documents? How is this period
determined? Is the retention period at least equal
to the lifetime of the device? Is it coordinated with
the retention period for corresponding records?
Are regulatory requirements considered?

Additional Notes:
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4.2.3 Are document changes reviewed and Is there a clearly stated requirement that changes
820.40(b) approved by the same function that to documents must be reviewed and approved by
performed the original review and the same function that issued the original
document, or by another, explicitly designated
approval (unless specifically designated
function? Is it implemented?
otherwise)?
Are changes in documents (mostly product and
Are change records maintained, including process specifications) backed by design change
description of the change, identification and/or process change records, such as
of the affected documents, approval engineering change notices? How is it
signatures and date, and when the defined/documented when document changes
change becomes effective? become effective?

4.2.4 Control of Records

4.2.4 Is there a documented procedure for the Are there documented instructions how to identify,
identification, storage, protection, organize, store, protect, and retrieve records? Are
retrieval, retention, and disposition of storage locations for records defined?
records?

4.2.4 Are retention periods for records Is a retention period defined for each type of
820.180(b) defined? record? How is this period determined? Is the
retention period at least two years or equivalent to
Are records retained for at least the the lifetime of the device, whichever is greater? Are
period of time equivalent to the regulatory requirements considered?

Additional Notes:
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Requirements What to look for and how Auditor notes and evidence
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expected life of the device, and no less

than 2 years?

4.2.4 Are records organized and maintained to Are records stored in dry, clean locations to
820.180 ensure that they remain legible, readily minimize deterioration? Is there a system for
identifiable and retrievable, and to organizing the records? Are boxes, drawers,
binders holding records properly identified? Are
prevent deterioration and loss?
records easily retrievable (test by asking for
Are records accessible to the regulatory retrieval of specific records)?
inspections? Are records kept in a location that is accessible to
Are electronic records backed up? regulatory inspections?
Are electronic records backed up? Are there
specific schedules, instructions, etc. for backing up
data? Where are the back-up media (tapes, disks,
etc.) kept?

4.2.4 For each type of device, is there a Device How is the DMR organized? Is it a file containing
820.181 Master Record (DMR) including, or the actual specifications documents, or is it a list
referring to appropriate device referring to these documents and their locations?
Is the DMR complete, e.g., includes all required
specifications, production process
categories of documents? Who decides, and how,
specifications, quality assurance
which documents are included in the DMR? Are all
procedures, packaging and labeling documents included in the DMR correctly
specifications, and installation, identified, reviewed, approved and otherwise
maintenance and servicing procedures controlled? Are the DMR documents the same (and

Additional Notes:
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Requirements What to look for and how Auditor notes and evidence
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and methods? the same revisions) as those used in production?

4.2.4 Are Device History Records (DHR) Are DHR records properly identified to specific
820.184 maintained for each manufactured batches, lots or units; and are the records easily
batch, lot or unit? (Refer also to ISO retrievable? (For other questions refer to 7.5.1)
13485 Clause 7.5.1 and 820.184)

4.2.4 Are Quality System Records (QSR) How is it determined and documented what quality
820.186 maintained, including current and system records are maintained (in QMS Manual
obsolete quality system manuals and and lists of procedures and quality forms, and in
operational procedures and work instructions)? Are
procedures, and records of quality
retention periods specified for obsolete quality
system activities such as management
system documentation and for quality system
reviews, corrective and preventive records?
actions, internal audits, etc.?

4.2.4 Are sufficient records maintained to Is there a list (or other documented specification)
provide evidence of conformity and of quality system records that are maintained by
effectiveness of the quality management the company? Are the records sufficient to
demonstrate product and process conformity, and
system?
the conformity and effectiveness of the quality
management system and its implementation?

5 Management Responsibility
5.1 Management Commitment

Additional Notes:
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5.1 Is the top management How is importance of meeting customer and other
communicating to the organization the requirements communicated? Do employees
importance of meeting customer and understand the consequences of failing to meet
requirements? Is there a quality policy? Are quality
other applicable requirements,
objectives defined? Are management reviews
establishing the quality policy,
being conducted regularly? Are adequate resources
establishing quality objectives, necessary for the quality system provided?
conducting management reviews, and
ensuring availability of resources?

5.2 Customer Focus

5.2 Is the top management ensuring that What measures are implemented to ensure that
customer requirements are determined customer requirements are determined and met
and are met? (processes, procedures, training, monitoring,
auditing, etc.)?

5.3 Quality Policy

5.3 Is there a documented quality policy; and Is the quality policy appropriate (relevant to the
820.20(a) Is it appropriate to the purpose of the types of products, type of market, customer
organization? expectations, etc.)? Does it include explicit
commitment to comply with requirements and
Does it include a commitment to
maintain (or improve) the effectiveness of the
comply with requirements and
quality system? Is it related to quality objectives?
maintain the effectiveness of the Would achievement of the quality objectives bring
quality management system? the company closer to achieving its overall quality

Additional Notes:
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Does it provide a framework for policy? Do employees know the meaning of the
establishing the quality objectives? quality policy and understand how they can
Is it communicated and understood contribute to achieving the policy? Is the quality
policy periodically reviewed by management
throughout the organization?
reviews? Has the policy ever been modified since it
Is it periodically reviewed for
was initially formulated?
continuing suitability?

Additional Notes:
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MANUFACTURER: PRODUCT / PROJECT:

ADDRESS: NAME, TITLE OF PERSON(S) VISITED:

CONTACT
NAME:

PHONE
#:

Additional Notes:
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FAX #:

E-MAIL:
AUDITORS (WITH TITLES): NATURE OF AUDIT: DATE OF AUDIT:

1. Due Diligence
2. Non-GMP
3. Post-Approval
4. Pre-Approval
5. Problem Instigated Audit
(for cause)
6. Prospective
Source/Qualifying Audit
7. Routine Audit/General GMP

Additional Notes:
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Section Title Page #
A Facilities and Equipment System 4
Building design, construction, maintenance, housekeeping
Environmental monitoring
Equipment (e.g., calibration, cleaning, maintenance, passivation, qualification)
Personnel (e.g., attire, health, hygienic, job descriptions, qualifications, training, staffing [supervisor to
employee ratios], consultants, etc.)
Pest control
Sanitation, disinfectant control and waste disposal
Security
SOPs
Utilities (e.g., clean room, HVAC, water systems, compressed air and gases, etc.) specifications,
approval, handling and control, qualification
Validation (computer, cleaning)
Zone concept, people and material flow (if applicable)
B Laboratory Control System 4
Glassware/utensil cleaning, validation, maintenance and storage
Methods development
Microbial monitoring and culture control
Personnel (e.g., attire, health, hygienic, job descriptions, qualifications, training, staffing [supervisor to
employee ratios], consultants, etc.)

Additional Notes:
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Raw data and lab notebook management

Reagents, solutions, standards, and media preparation
SOPs, specifications and test procedures
Stability program
Testing requirements, interpretation of results and reporting
Validation (computer, methods)
C Material System 5
Label accountability, destruction, storage
Material accountability, handling, segregation, storage, reject/quarantine/approval status and control
Personnel (e.g., attire, health, hygienic, job descriptions, qualifications, training, staffing [supervisor to
employee ratios], consultants, etc.)
Restricted access
Shipping studies
SOPs
Stock rotation
Storage temperature/humidity validation and control
D Packaging and Labeling System 6
Batch Records (e.g., issuance, control, completion, etc.)
Cross-contamination potential
Labeling
Personnel (e.g., attire, health, hygienic, job descriptions, qualifications, training, staffing [supervisor to
Additional Notes:
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employee ratios], consultants, etc.)

Reprocessing
Restricted access
Separation of Operations
SOPs
Time limitations on production
Validation (computer, process)

Section Title Page #

E Production System 9
Batch Records ((e.g., issuance, control, completion, calculation of yields, charge in of components, etc.)
Compounding
Glassware/utensil cleaning, maintenance, and storage
Personnel (e.g., attire, health, hygienic, job descriptions, qualifications, training, staffing [supervisor to
employee ratios], consultants, etc.)
Reprocessing
Restricted access
Separation of Operations
SOPs
Time limitations on production
Validation (cleaning, computer, process)
Additional Notes:
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F Quality System 12
Annual product reviews
Application submissions (original, supplements, annual reports, etc.)
Approval/quarantine/rejection
Auditing program
Authority
Change control
Complaints
Investigations
Master records
NDA Field Alerts
Personnel (e.g., attire, health, hygienic, job descriptions, qualifications, training, staffing [supervisor to
employee ratios], consultants, etc.)
Product recalls
Record retention
Reserve samples
Returned Goods
Sampling of materials/products
Sampling plans
SOPs
SOP System
Additional Notes:
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Specifications
Supplier histories
Training program
Vendor approval /qualification/ disqualification
G Components Worksheet 15
H Packing Materials Worksheet 18
I In-Process, Sub-Assemblies, Bulk and Final Product Worksheet 21
J Equipment Qualification and Maintenance Worksheet 23

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A. Facilities and Equipment System YES NO N/A COMMENTS GMP REG.

1. Are the facilities acceptable for the 211.
nature of the item being 42
produced?
2. Is security adequate (e.g., building 1301.7
perimeter, internal areas within 3
building, limits on employee
access, etc.)?
3. Are sanitation and maintenance 211.56
procedures of the manufacturing
and ventilation equipment being
followed?
4. Are there adequate written 211.16
calibration procedures? Is there a 0
record of the calibrations being
performed? All equipment is
identified? Remedial action?
5. Is there a formal maintenance 211.42
schedule for manufacturing 211.56
equipment? Is it kept visible near 211.67
each piece of equipment?
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6. Pest control procedure(s) in place 211.56

and followed?
7. Hazardous materials and waste 211.56
procedures in place and followed?
8. Temperature and humidity 211.42
controls procedure(s) in place and
followed?
9. Facility cleaning and maintenance 211.50
procedures in place and followed?
B. Laboratory Control System
1. Are the lab facilities adequate? 211.22
2. Do the facilities have adequate 211.22
equipment for the facilitation of
function?
3. Have laboratory test methods
been validated?
4. In cases of computer systems for
control of processes, data
collection, etc., have they been
validated?

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5. Do procedures exist for the proper

cleaning, maintenance and storage
of lab glassware/utensils?
6. Has cleaning validation been
performed to ensure proper
cleaning? If not, how is
cleanliness assured?
7 Are all components, 211.22
manufacturing materials, in- 211.84
process materials, packaging
materials, and labeling inspected
or tested prior to release for
production?
8. Are test procedures documented? 211.16
0
9. Are raw material file samples 211.17
maintained for future reference? 0

B. Laboratory Control System YES NO N/A COMMENTS GMP REG.

continued
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10. Are the laboratory reagents and 211.16

other chemical supplies identified 5
and given expiration dates?
11. Are the laboratory instruments 211.16
requiring calibration maintained 0
according to the calibration
procedures?
12. Are there written procedures for 211.10
production control? 0
13. Do the production employees 211.25
appear to be neat, clean, suitably
attired, organized, and operating
efficiently?
14. Do the responsible heads of 211.25
various functional groups have the
necessary education, training, and
experience to perform their
functions?
15. Do all employees have the 211.25
necessary education, training, and
experience to perform their
functions?

Additional Notes:
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C. Material System
1. Is access to stockrooms and 211.12
material storage areas restricted 2
to authorized personnel?
2. Are materials handled, identified, 211.80
and stored in a manner that will
prevent damage, contamination,
mix-up, or loss?
3. Are accountability records kept to 211.18
permit traceability of usage? 4
4. Are stocks re-inspected and tested 211.87
at regular intervals?
5. Are stocks rotated according to 211.86
FIFO?
6. System in place for handling non- 211.12
conforming materials? 5
7. Are there materials, storage, and 211.14
handling procedures? 2
8. Are there effective controls to 1307.7
guard against theft or diversion of 1
controlled substances?
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9. Is an inventory of controlled 1304.1

substances taken at least every 3
two years?
10. Are non-controlled drugs stored 1301.7
with controlled drugs? If yes, has 2
formal permission been obtained
for the regional director of DEA?
11. Is there a sufficient accountability 211.12
system for labels? 5
12. Is the label room designed to avoid 211.42
mix-ups? 211.12
2
13. Are there specified restrictions on 211.12
authority for access to labels and 2
other labeling?
C. Material Control System YES NO N/A COMMENTS GMP REG.
continued

Additional Notes:
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14. Have shipping studies been

performed to ensure that packages
are packed properly to ensure that
damage does not occur that would
have adverse effects on the
product/material?
15. Has storage temperature/humidity
validation been performed (if
applicable)
16. Are adequate storage facilities 211.42
available and in use to safeguard 211.14
the quality of the product between 2
final acceptance and shipping?
17. Is a rotated stock system 211.15
employed to assure that oldest 0
approved products are shipped
first?
18. Are products prepared for
shipment in a manner to preclude
damage during transit?

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19. Hazardous products properly

identified?
20. Is there a system to assure that 211.65
only products approved for release
are distributed?
21. Do the production employees 211.25
appear to be neat, clean, suitably
attired, organized, and operating
efficiently?
22. Do the responsible heads of 211.25
various functional groups have the
necessary education, training, and
experience to perform their
functions?
23. Do all employees have the 211.25
necessary education, training, and
experience to perform their
functions?
D. Packaging and Labeling System

Additional Notes:
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1. Do the production employees 211.25

appear to be neat, clean, suitably
attired, organized, and operating
efficiently?
2. Do the responsible heads of 211.25
various functional groups have the
necessary education, training, and
experience to perform their
functions?
3. Do all employees have the 211.25
necessary education, training, and
experience to perform their
functions?
4. Are there written procedures for 211.10
production control? 0
5. Are the written procedures being 211.10
followed? 0
6. Does the production equipment 211.63
appear to be appropriately 211.65
designed, constructed, and
maintained?

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7. Are production areas sufficient in 211.42

size, construction, and location?
D. Packaging and Labeling System YES NO N/A COMMENTS GMP REG.
continued
8. Are appropriate exhaust and 211.46
vacuum systems employed in
operations to minimize air
contamination?
9. Are equipment cleaning logs 211.18
maintained? 2
10. Are batch history production records properly 211.18
assembled and sufficient?
6
211.18
8
a. Is each prepared, dated, and
signed in full signature by one
person and independently
checked, dated, and signed by a
second person?

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11. Are preclearance procedures 211.30

employed to prevent packaging
and labeling mix-ups?
12. Are there acceptable written 211.11
procedures for reprocessing 5
batches?
13. Are the batch records kept at the 211.10
workstations during the entire 0
operation and the directions
strictly followed?
14. Are critical steps performed by a 211.10
competent individual, checked by 3
a second individual, and recorded
in the batch record?
15. Have time limitations on the 211.11
holding of processing and in- 1
process items been established
and are they being adhered to?

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16. Are changes to the issued batch 211.10

records approved prior to the start 0
of work and documented on the
batch records?
17. Do the production employees 211.25
appear to be neat, clean, suitably
attired, organized, and operating
efficiently?
18. Are proper gowning 211.28
techniques/coverings employed?
19. Do the responsible heads of 211.25
various functional groups have the
necessary education, training, and
experience to perform their
functions?
20. Do all employees have the 211.25
necessary education, training, and
experience to perform their
functions?
21. Are changes to specifications 211.10
formally approved with original 0
ANDA/NDA criteria considered?

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22. Is labeling issued for production 211.12

use examined for identity, correct 5
expiration date, control number,
storage conditions, handling
instructions, and additional
processing instructions?

D. Packaging and Labeling System YES NO N/A COMMENTS GMP REG.

continued
23. Is the labeling inspection 211.13
documented to include the date 0
and person performing the
inspection? Is the inspection
included in batch record?
24. Are packaging lines spatially or 211.42
physically separated to prevent
mix-ups?

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25 Are bagged or boxed components, 211.80

packaging materials or finished
product stored off the floor and
suitably spaced to permit cleaning
and inspection?
26. When non-employees, such as 211.28
visitors enter the area, does the
designated responsible person
observe them?
27. Are recorder charts used to
monitor time, temperature and
pressure on appropriate
equipment?
28. Are chart records reviewed at
proper intervals?
29. Are lubricants and coolants 211.65
controlled properly such that they
cannot come in contact with
product containers, closures, in-
process materials or finished
products?
Additional Notes:
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30. Are changes to specifications 211.10

formally approved with design 0
criteria considered?
31. Are all in-process products 1301.7
returned to the controlled drug 3
storage areas at the termination of
the process or workday? If not,
are the materials securely locked
to prevent access?
32. Are manufacturing areas for 1301.7
controlled substances clearly 3
defined, limited in access and
under the surveillance of a
designated individual provided in
writing?
33. Have all manufacturing, packaging,
inspection equipment, and
processes been validated/
qualified to address the following:

Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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a. Have operating limits /

settings on the equipment
been qualified as being
capable to achieve the
desired results?
b. Are operating limits from
the validation reflected in an
operating procedure for
employees to follow?
c. Was validation achieved
without equipment failures,
interruptions, or significant
down time?

D. Packing and Labeling System YES NO N/A COMMENTS GMP REG.

continued

Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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d. Was the validation long

enough in duration to
simulate a typical batch
size? On continuous
processes, was the
validation long enough to
encompass power
fluctuations, employee shift
changes, and other factors
that can occur during a 24
hour period?

34. In cases of computer systems for

control of processes, data
collection, etc., have they been
validated?
35. Is there a formal change control
system that addresses changes to
validated systems and includes
quality review/approval?
E. Production System
Additional Notes:
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1. Do the production employees

appear to be neat, clean, suitably
attired, organized, and operating
efficiently?
2. Do the responsible heads of 211.25
various functional groups have the
necessary education, training, and
experience to perform their
functions?
3. Do all employees have the 211.25
necessary education, training, and
experience to perform their
functions?
4. Are there written procedures for
production control?
5. Are the written procedures being
followed?
6. Does the production equipment
appear to be appropriately
designed, constructed, and
maintained?

Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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7. Are production areas sufficient in

size, construction, and location?
8. Are appropriate exhaust and
vacuum systems employed in
operations to minimize air
contamination?
9. Are equipment cleaning logs
maintained?
10. Are master and batch history production records
properly assembled and sufficient?
11. Is each prepared, dated, and
signed in full signature by one
person and independently
checked, dated, and signed by a
second person?
12. Are there acceptable written
procedures for reprocessing
batches?

E. Production System continued YES NO N/A COMMENTS GMP REG.

Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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13. Are the batch records kept at the

workstations during the entire
operation and the directions
strictly followed?
14. Are critical steps performed by a
competent individual, checked by
a second individual, and recorded
in the batch record?
15. Have time limitations on the
holding of processing and in-
process items been established
and are they being adhered to?
16. Are changes to the issued batch 211.84

records approved prior to the start

of work and documented on the
batch records?
17. Are proper gowning
techniques/coverings employed?
18. Are changes to specifications 211.84

formally approved with original

ANDA/NDA criteria considered?
Additional Notes:
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____________________________________________________________________________________________
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19. Are packaging lines spatially or 211.84

physically separated to prevent

mix-ups?
20 Are bagged or boxed components, 211.84

packaging materials or finished

product stored off the floor and
suitably spaced to permit cleaning
and inspection?
21. When non-employees, such as 211.84

visitors enter the area, does the

designated responsible person
observe them?
22. Are recorder charts used to 211.84

monitor time, temperature and

pressure on appropriate
equipment?
23. Are chart records reviewed at 211.84

proper intervals?

Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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24. Are lubricants and coolants 211.84

211.184
controlled properly such that they
cannot come in contact with
product containers, closures, in-
process materials or finished
products?
25. Are changes to specifications 211.84

formally approved with design

criteria considered?
26. Are all in-process products 211.42
returned to the controlled drug
storage areas at the termination of
the process or workday? If not,
are the materials securely locked
to prevent access?

Additional Notes:
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________

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27. Are manufacturing areas for 211.80

controlled substances clearly
defined, limited in access and
under the surveillance of a
designated individual provided in
writing?

E. Production System continued YES NO N/A COMMENTS GMP REG.

28. Have all manufacturing, packaging,
inspection equipment, and
processes been validated/
qualified to address the following:
a. Have operating limits /
settings on the equipment
been qualified as being
capable to achieve the
desired results?

Additional Notes:
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________

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e. Are operating limits from

the validation reflected in an
operating procedure for
employees to follow?
f. Was validation achieved
without equipment failures,
interruptions, or significant
down time?
g. Was the validation long
enough in duration to
simulate a typical batch
size? On continuous
processes, was the
validation long enough to
encompass power
fluctuations, employee shift
changes, and other factors
that can occur during a 24
hour period?
29. Have all cleaning procedures been
validated?
Additional Notes:
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________

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30. In cases of computer systems for

control of processes, data
collection, etc., have they been
validated?
31. Is there a formal change control
system that addresses changes to
validated systems and includes
quality review/approval?
F. Quality System
1. Does QA/QC have written 211.22
procedures to assure that
production records are reviewed?
2. Is there a final inspection 211.22
performed by quality on a batch by
batch basis?
3. Is there a thorough investigation of 211.19
all discrepancies found during the 2
final review of the production
documents?
4. Is the product checked for correct 211.13
expiration dating? 7
Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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3. Are valid sampling plans used? 211.16

5
4. Do the sampling procedures 211.16
specify how the samples are to be 5
obtained and by whom?
5. Is there a classification of defects? 211.16
5
6. Are reserve samples of finished 211.17
products maintained? 0
7. Have the accuracy, sensitivity, 211.16
specificity, and reproducibility of 5
test methods been demonstrated
via validation?

F. Quality System continued YES NO N/A COMMENTS GMP REG.

8. In cases where product does not 211.19
meet performance specifications, 2
is there a formal investigation with
conclusions and adequate follow-
up?

Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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9. Does quality assurance/control 211.22

have the authority to approve /
reject plant, equipment, process,
and procedural changes?
10. Is there a product master record 211.18
for each product that includes: 6
a. Product specifications?
b. Product drawings?
c. Product composition?
d. Product formulation?
e. Compendial references?
f. Component specifications?
g. Production process
specifications?
h. Production equipment?
i. special precautions?
j. production methods?
k. cleaning methods?
l. production procedures and
sequences?

Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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m. production environmental
specifications?
n. quality assurance procedures?
o. quality assurance
specifications?
p. quality assurance checks
performed?
q. expected yields?
r. quality assurance apparatus 211.18
used? 6
s. packaging and labeling
specifications?
t. packaging and labeling
methods?
u. packaging and labeling
procedures?
v. full information on
components, vendors, and
specifications?
w. copies of critical component
vendor agreements?
Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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x. copies of labels, labeling

procedures?
y. storage conditions?
z. shelf life information?
11. Is rejected material adequately 211.80
controlled?
12. Are the sampling plans employed 211.84
by QA/QC sufficient?
13. Is the sampling of received 211.80
materials performed in a separate
area or with proper controls?
14. Is the cause for rejected material 211.84
determined and follow-up
performed?

F. Quality System continued YES NO N/A COMMENTS GMP REG.

15. For controlled substances do the 1304.22
receiving records include the
name, address and registration
number of the person from whom
the substance was received?
Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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16. Are receiving bays designed such 211.80

that materials being received will
not get wet when it is raining or
snowing?
17. If the receipt of an item contains 211.84
more than one lot of that item in
the shipment, are all the lots
separately tested?
18 Is there an adequate procedure for 211.204
the handling and disposition of
returned goods?
19. Is there as adequate change
control system?

20. Are production records retained 211.18

for appropriate time periods? 0
211.67
21. Is an adequate product complaint / 211.98
failure handling system in effect
and are investigations processed
properly?
Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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22. NDA-Field Alert system in place in 314.81

accordance with 314.81(a)1?
23. Product recalls system in place? 211.20
Procedure? 4
24. Is there an adequate stability 211.16
program? 6
25. Is there a listing of qualified 211.84
suppliers?
26. Are suppliers histories maintained? 211.84
27. Do the responsible heads of 211.25
various functional groups have the
necessary education, training, and
experience to perform their
functions?
28. Do all personnel have the 211.25
necessary education, training, and
experience to perform their
functions?
29. Does QA approve application
submissions (original,
supplements, annual reports,
etc.)?

Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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30. Does an auditing program exist?

31. Are Annual Product Reviews 211.18
performed and properly 0(e)
documented?

Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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COMPONENTS
PACKAGING MATERIALS
IN-PROCESS, SUB-ASSEMBLIES, BULK AND FINAL PRODUCT
EQUIPMENT QUALIFICATION AND MAINTENANCE

WORKSHEETS

Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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G. COMPONENTS WORKSHEET

ITEM STATUS
Specifications Test Sampling Sampling Vendor(s) Storage Stability
Method Plans Methods Condition
1.
2.
3.
4.
5.
6.
7.
8.
Comments: -
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
____________________________________

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G. Components YES NO N/A COMMENTS GMP REG.

1. Specifications
a. Have comprehensive 211.84
specifications been written and
approved by QA/QC?
b. Have they been reviewed and
agreed to by the vendors?
2. Test Methods
a. Do formalized acceptable test 211.160
methods exist for each material?
b. Are the methods the same as
those employed by the source of
the item? If not, has the source
agreed to accept
release/rejection of material by
the different methodology?
c. Have the test methods been 211.165
validated? 211.194

Additional Notes:
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____________________________________________________________________________________________
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d. Does the QA/QC laboratory 211.22

performing the routine testing
have the necessary equipment?
e. Have the laboratory personnel 211.25
been properly trained to
perform the test methods?
f. From a safety perspective, is the 211.22
present laboratory facility
acceptable for performing
testing?
g. Have all the necessary standards 211.165
and reagents for tests been
procured and the shelf
life/retest periods for each been
determined?
h. Are all tests performed in
house?
3. Sampling Plans
a. Have formalized acceptable 211.84
statistical sampling plans been
derived for each item?
Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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4. Sampling Methods
a. Have formal methods for the 211.80
obtainment of the sample been 211.84
derived? Have safety
precautions been taken into
consideration?
5. Vendors
a. Has at least one vendor been 211.84
qualified and approved by
QA/QC for each item?
b. Have the shipping requirements 211.84
been specified; such as drum,
bags, and quantity per pallet?

6. Storage Conditions/Material YES NO N/A COMMENTS GMP REG.

Handling
Additional Notes:
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a. Have the storage and handling 211.82

of each item been considered, 211.87
planned for and agreed upon
with material control functions?

7. Stability
a. Are the material and source the 211.66
same as that qualified by R & D?
If not, have studies been
performed to qualify the
material to assure that it will not
have a negative impact on
product stability?
Use Components Worksheet page 15

Additional Notes:
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________

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H. PACKAGING MATERIALS WORKSHEET

ITEM STATUS
Specificatio Test/ Sampling Sampling Vendor(s) Storage Stabilit
ns Inspection Plans Methods Condition / y
Method Material
Handling
1.
2.
3.
4.
5.
6.
7.

Comments: -
________________________________________________________________________________________
Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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H. Packaging Materials YES NO N/A COMMENTS GMP REG.

1. a. Have comprehensive 211.84
specifications been written and
approve by QA/QC?
b. Have they been reviewed by the
intended vendors and agreed
to?
c. Have tolerances been 211.84
established for critical
parameters?
d. Have defect classifications been 211.84
derived?
e. Have acceptance quality levels 211.84
(AQLs) been established for each
defect?
f. Do part drawings and, where 211.84
applicable, tool drawings exist?
2. Test and Inspection Methods

Additional Notes:
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a. Do formalized acceptable 211.160

methods exist for each
component and material?
b. Are the methods the same as
those employed by the source of
the item? If not, has the source
agreed to accept the different
methodology as a basis for
release/rejection of component
lots?
c. Does the quality control 211.22
laboratory have the necessary
equipment to do the testing and
inspections properly?
d. Have the inspection and test 211.165
methods been performed in a 211.194
laboratory to assure that there
are no problems?

Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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e. Have the personnel who will be 211.25

performing the testing and
inspections been properly
trained?
f. Have safety precautions been 211.22
taken into consideration for
each test and inspection method
to assure that the present
laboratory facilities are
acceptable?
3. Sampling Plans
a. Have formalized acceptable 211.84
statistical sampling plans been
derived for each item?
4. Vendors
a. Has at least one vendor been 211.84
qualified and approved by
QA/QC for each item?

Additional Notes:
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____________________________________________________________________________________________
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b. Have the shipping requirements 211.84

been specified; such as drum,
bags, and quantity per pallet?

H. Packaging Materials continued YES NO N/A COMMENTS GMP REG.

5. Storage Conditions and Material
Handling
a. Has the storage and handling of 211.82
each item been considered, 211.87
planed for and agreed upon with
the materials control functions?
6. Stability
a. Is the material or component 211.66
source the same as that
qualified by R & D? If not, have
stability studies been performed
to qualify the material to assure
it will not have a negative impact
of product quality?
Additional Notes:
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____________________________________________________________________________________________

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Use Packaging Materials Worksheet page 18

I. IN-PROCESS, SUB-ASSEMBLIES, BULK AND FINAL PRODUCT WORKSHEET

PROCESS STAGE STATUS

Specificatio Test/ Sampling Sampling Validation Storage Stability
ns/ Inspection Plans Methods Condition/
Batch Method Material
Record Handling
1.
2.
3.
4.
5.
6.
7.
8.
Comments: -
Additional Notes:
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____________________________________________________________________________________________

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I. In-Process, Sub-Assemblies, Bulk and YES NO N/A COMMENTS GMP REG.

Final Product
1. Specifications
a. Have comprehensive 211.22
specifications been written and 211.84
approved by QA/QC for each 211.100
phase (e.g., assembly, 211.122
formulation, tableting, filling, 211.160
etc.)? Are the specifications
comprehensive in content and
include tolerances and
acceptance limits?
2. Test and Inspection Methods
a. Do validated test methods exist 211.160
for each material stage? 211.165
b. Have the personnel who will be 211.25
performing the testing or
inspections been properly
trained?
Additional Notes:
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____________________________________________________________________________________________
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c. Have all the necessary standards 211.165

and reagents for tests been
procured? Have the shelf life
and retest periods for each been
determined?
d. Does the quality control 211.22
laboratory have the necessary 211.160
equipment to do the
testing/inspection properly and
safely?
3. Sampling Plans
a. Have formalized acceptable 211.165
statistical sampling plans been
derived for each stage of
processing?
4. Sampling Methods

Additional Notes:
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____________________________________________________________________________________________
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a. Have formal methods for the 211.165

obtainment of the sample from
the manufacturing process been
derived? Have necessary safety
precautions been taken into
consideration?
5. Validation/Qualifications
a. Have all necessary and 211.80
appropriate validations
pertinent to the product been
performed?
6. Storage Conditions and Material
Handling
a. Have the storage and handling
of each item been taken into
consideration, planned for and
agreed upon?

Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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b. Have the expiration periods for 211.87

storage of in-process and final 211.111
product items been established?
Has a retest program been
derived for in-process items that
have exceeded the expiration
period?
Use In-Process, Sub-Assemblies, Bulk Product, and Final Product Worksheet page 21.

Additional Notes:
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________

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J. EQUIPMENT QUALIFICATION AND MAINTENANCE WORKSHEET

EQUIPMENT STATUS
Specifications Validation Manufacturing Maintenance Maintenance
Procedure Procedure Schedule

1.
2.
3.
4.
5.
6.
7.
8.

J. Equipment Qualification and YES NO N/A COMMENTS GMP REG.

Maintenance
Additional Notes:
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____________________________________________________________________________________________
____________________________________________________________________________________________

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1. Specifications
a. Has a file of equipment 211.100
specifications been derived and
maintained for future reference.
2. Qualifications
a. Have all necessary and 211.63
appropriate qualifications 211.67
pertinent to the equipment 211.68
been performed? 211.113
3. Procedures
a. Have specific manufacturing 211.100
operating procedures been
written for each piece of
equipment and each
manufacturing process?
b. Have personnel been properly 211.25
trained in performing
manufacturing and maintenance
functions?
4. Schedules

Additional Notes:
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____________________________________________________________________________________________
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a. Has the maintenance 211.42

department, in conjunction with 211.56
QA/QC and engineering, derived 211.67
specific formalized maintenance
procedures and schedules for
each piece of equipment,
processes and support systems
such as water, compressed air,
vacuum?

Additional Notes:
____________________________________________________________________________________________
____________________________________________________________________________________________
____________________________________________________________________________________________

Confidential and propriety information for training purposes only

PW_MC_Audit_Management_2011_v8_r8 68