Question Instructions/Questions Yes/No/NA

Note any exceptions and comments in notebook

General Controls
1 Does the facility and its many departments (organizational
units) operate in a state of control as defined by the GMP
regulations?
Organizational & Management Responsibilities
1 Does this facility/business unit operate under a facility or
corporate quality policy?
2 Does a Quality Assurance unit (department) exist as a
separate organizational entity?
3 Does the Quality Assurance unit alone have both the
authority and responsibility to approve or reject all
components, drug product containers and closures, in-
process materials, packaging materials, labeling and drug
products?
4 Does the QA department or unit routinely review production
records to ensure that procedures were followed and
properly documented?
5 Are adequate laboratory space, equipment, and qualified
personnel available for required testing?
6 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 adequate?
7 Date of last inspection: ____________________
8 Are all QA procedures in writing?
9 Are all QA responsibilities in writing?
10 Are all written QA procedures current and approved?
(Review log of procedures)
11 Are the procedures followed? (Examine records to ensure
consistent record-keeping that adequately documents
testing.)
12 Are QA supervisory personnel qualified by way of training
and experience?

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 13 Are other QA personnel, e.g., chemists, analysts, laboratory
technicians) qualified by way of training and experience?
14 Does the QA unit have a person or department specifically
charged with the responsibility of designing, revising, and
obtaining approval for production and testing procedures,
forms, and records?
15 Does a written SOP, which identifies how the form is to be
completed and who signs and countersigns, exist for each
record or form?
16 Is the production batch record and release test results
reviewed for accuracy and completeness before a batch/lot
of finished products is released?

Question Instructions/Questions Yes/No/NA

Note any exceptions and comments in notebook
Employee Orientation, Quality Awareness, and Job Training
1 Circle the types of orientation provided to 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.
2 Does each employee receive retraining on an SOP
(procedures) if critical changes have been made in the
procedure?
3 Indicate how on-going, periodic GMP training is
accomplished.
4 Is all training documented in writing that indicates the date
of the training, the type of training, and the signature of both
the employee and the trainer?
5 Are training records readily retrievable in a manner that
enables one to determine what training an employee has
received, which employees have been trained on a particular
procedure, or have attended a particular training program?
6 Are GMP trainers qualified through experience and training?
7 Are supervisory personnel instructed to prohibit any
employee who, because of any physical condition (as
determined by medical examination or supervisory
observation) that may adversely affect the safety or quality

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 of drug products, from coming into direct contact with any
drug component or immediate containers for finished
product?

8 Are employees required to report to supervisory personnel

any health or physical condition that may have an adverse
effect on drug product safety and purity?
9 Are temporary employees given the same orientation as
permanent employees?
10 Are consultants, who are hired to advise on any aspect of
manufacture, processing, packing or holding, of approval for
release of drug products, asked to provide evidence of their
education, training, and experience?
11 Are written records maintained stating the name, address,
qualifications, and date of service for any consultants and
the type of service they provide?

Question Instructions/Questions Yes/No/NA

Note any exceptions and comments in notebook
Plant Safety and Security
1 Does this facility have a facility or corporate safety program?
2 Are safety procedures written?
3 Are safety procedures current?
4 Do employees receive safety orientation before working in
the plant area?
5 Is safety training documented in a readily retrievable
manner that states the name of the employee, the type of
training, the date of the training, and the name of the trainer
and the signature of the trainer and the participant?
6 Does this facility have a formal, written security policy?
7 Is access to the facility restricted?
8 Describe how entry is monitored/restricted:
9 Is a security person available 24 hours per day?
Internal Quality/GMP Audit Program
1 Does this business unit/facility have a written quality policy?
2 Is a copy of this quality policy furnished to all employees?

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 3 If "yes" to above, when provided? __________________
4 Is training provided in quality improvement?
5 Does a formal auditing function exist in the Quality
Assurance department?
6 Does a written SOP specify who shall conduct audits and
qualifications (education, training, and experience) for those
who conduct audits?
7 Does a written SOP specify the scope and frequency of audits
and how such audits are to be documented?
8 Does a written SOP specify the distribution of the audit
report?
Quality Cost Program
1 Does this facility have a periodic and formal review of the
cost of quality?
2 Does this facility have the ability, through personnel,
software, and accounting records, to identify and capture
quality costs?
3 Does this facility make a conscious effort to reduce quality
costs?

Question Instructions/Questions Yes/No/NA

Note any exceptions and comments in notebook
Design Control
1 Not directly related to 21 CFR Parts 210 and 211
Facility Control
Facility Design and Layout
1 Are all parts of the facility constructed in a way that makes
them suitable for the manufacture, testing, and holding of
drug products?
2 Is there sufficient space in the facility for the type of work
and typical volume of production?
3 Does the layout and organization of the facility prevent
contamination?
Environmental Control Program

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 1 The facility is NOT situated in a location that potentially
subjects workers or product to particulate matter, fumes, or
infestations?
2 Are grounds free of standing water?
3 Is lighting adequate in all areas?
4 Is adequate ventilation provided?
5 Is control of air pressure, dust, humidity and temperature
adequate for the manufacture, processing, storage or
testing of drug products?
6 If air filters are used, is there a written procedure specifying
the frequency of inspection and replacement?
7 Are drains and routine cleaning procedures sufficient to
prevent standing water inside the facility?
8 Does the facility have separate air handling systems, if
required, to prevent contamination? (MANDATORY IF
PENICILLIN IS PRESENT!)
Facility Maintenance and Good Housekeeping Program
1 Is this facility free from infestation by rodents, birds, insects
and vermin?
2 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?
3 Is this facility maintained in a clean and sanitary condition?
4 Does this facility have written procedures that describe in
sufficient detail the cleaning schedule, methods, equipment
and material?
5 Does this facility have written procedures for the safe and
correct use of cleaning and sanitizing agents?
6 Are all parts of the facility maintained in a good state of
repair?
7 Is sewage, trash and other refuse disposed of in a safe and
sanitary manner (and with sufficient frequency?)
Outside Contractor Control Program
1 Are contractors and temporary employees required to
perform their work under sanitary conditions?

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 2 Are contractors qualified by experience or training to
perform tasks that may influence the production, packaging,
or holding of drug products?

Question Instructions/Questions Yes/No/NA

Note any exceptions and comments in notebook
Equipment Control
Equipment Design and Placement
1 Is all equipment used to manufacture, process or hold a drug
product of appropriate design and size for its intended use?
2 Are the following pieces of equipment suitable for their
purpose? Blender(s), Conveyor(s), Tablet, Presses, Capsule
Fillers, Bottle Fillers, Other (specify).
3 Are the following pieces of equipment suitable in their
size/capacity? Blender(s), Conveyor(s), Tablet, Presses,
Capsule Fillers, Bottle Fillers, Other (specify).
4 Are the following pieces of equipment suitable in their
design? Blender(s), Conveyor(s), Tablet, Presses, Capsule
Fillers, Bottle Fillers, Other (specify).
5 Are the locations in the facility of the following pieces of
equipment acceptable? Blender(s), Conveyor(s), Tablet,
Presses, Capsule Fillers, Bottle Fillers, Other (specify).
6 Are the following pieces of equipment properly installed?
Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers,
Bottle Fillers, Other (specify).
7 Is there adequate space for the following pieces of
equipment? Blender(s), Conveyor(s), Tablet, Presses,
Capsule Fillers, Bottle Fillers, Other (specify).
8 Are machine surfaces that contact materials or finished
goods non-reactive, non-absorptive, and non-additive so as
not to affect the product?
9 Are design and operating precautions taken to ensure that
lubricants or coolants or other operating substances do NOT
come into contact with drug components or finished
product?
10 Fiber-releasing filters are NOT used in the production of
injectable products?
11 Asbestos filters are NOT used in the production of products?

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 12 Is each idle piece of equipment clearly marked "needs
cleaning" or "cleaned; ready for service"?
13 Is equipment cleaned promptly after use?
14 Is idle equipment stored in a designated area?
15 Are written procedures available for each piece of
equipment used in the manufacturing, processing or holding
of components, in-process material or finished product?
16 Do cleaning instructions include disassembly and drainage
procedure, if required, to ensure that no cleaning solution or
rinse remains in the equipment?
17 Does the cleaning procedure or startup procedure ensure
that the equipment is systematically and thoroughly
cleaned?

Question Instructions/Questions Yes/No/NA

Note any exceptions and comments in notebook
Equipment Identification
1 Are all pieces of equipment clearly identified with easily
visible markings?
2 Are all pieces of equipment also marked with an
identification number that corresponds with an entry in an
equipment log?
3 Does each piece of equipment have written instructions for
maintenance that includes a schedule for maintenance?
4 Is the maintenance log for each piece of equipment kept on
or near the equipment?
Equipment Maintenance & Cleaning
1 Are written procedures established for the cleaning and
maintenance of equipment and utensils?
2 Are these procedures followed?
3 Does a written procedure assign responsibility for the
cleaning and maintenance of equipment?
4 Has a written schedule been established and is it followed
for the maintenance and cleaning of equipment?
5 Has the cleaning procedure been properly validated?

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 6 If appropriate, is the equipment sanitized using a procedure
written for this task?
7 Has a sufficiently detailed cleaning and maintenance
procedure been written for each different piece of
equipment to identify any necessary disassembly and
reassembly required to provide cleaning and maintenance?
8 Does the procedure specify the removal or obliteration of
production batch information from each piece of equipment
during its cleaning?
9 Is equipment cleaned promptly after use?
10 Is clean equipment clearly identified as "clean" with a
cleaning date shown on the equipment?
11 Is clean equipment adequately protected against
contamination prior to use?
12 Is equipment inspected immediately prior to use?
13 Are written records maintained on equipment cleaning,
sanitizing and maintenance on or near each piece of
equipment?
Measurement Equipment Calibration Program
1 Does the facility have approved 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.)
2 Are records of calibration checks and inspections
maintained in a readily retrievable manner?
Equipment Qualification Program
1 Verify that all pieces of equipment used in production,
packaging, and quality assurance are capable of producing
valid results.
2 When computers are used to automate production or
quality testing, have the computer and software been
validated?
3 Have on-site tests of successive production runs or tests
been used to qualify equipment?
4 Were tests repeated a sufficient number of times to ensure
reliable results?

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 5 Is each piece of equipment identified to its minimum and
maximum capacities and minimum and maximum operating
speeds for valid results?
6 Have performance characteristics been identified for each
piece of equipment? (May be provided by the manufacturer,
but must be verified under typical operations conditions.)
7 Have operating limits and tolerances for performance been
established from performance characteristics?

Question Instructions/Questions Yes/No/NA

Note any exceptions and comments in notebook
Material/Component Control
Material/Component Specification and Purchasing Control
1 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.
2 Has each supplier/vendor of material or component been
inspected/audited for proper manufacturing controls?
(Review suppliers and audits and enter names, material
supplied, and date last audited in notebook.)
Material/Component Receipt, Inspection, Sampling, and Laboratory
Testing
1 Does the facility have current written procedures for
acceptance/rejections of drug products, containers,
closures, labeling and packaging materials? (List selected
materials and components in notebook and verify
procedures.)
2 Is each lot within each shipment of material or components
assigned a distinctive code so material or component can be
traced through manufacturing and distribution?
3 Does inspection start with visual examination of each
shipping container for appropriate labeling, signs of
damage, or contamination?
4 Is the number of representative samples taken from a
container or lot based on statistical criteria and experience
with each type of material or component?

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 5 Is the sampling technique written and followed for each type
of sample collected?
6 Is the quantity of sample collected sufficient 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:
7 Containers are cleaned before samples are removed.
8 Stratified samples are not composited for analysis.
9 Containers from which samples have been taken are so
marked indicating date and approximate amount taken.
10 Each sample container is clearly identified by material or
component name, lot number, date sample taken, name of
person taking sample, and original container identification.
11 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.
12 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.
13 Microbiological testing is conducted where appropriate.
Material Component Storage and Handling
1 (Verify that materials and components are stored and
handled in a way that prevents contamination, mixups, and
errors.)
2 Are incoming material and components quarantined until
approved for use?
3 Are all materials handled in such a way to prevent
contamination?
4 Are all materials stored off the floor?
5 Are materials spaced to allow for cleaning and inspection?
6 Are labels for different products, strengths, dosage forms,
etc., stored separately with suitable identification?
7 Is label storage area limited to authorized personnel?
8 Are rejected components, material, and containers
quarantined and clearly marked to prevent their use?

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Inventory Control Program
1 Are inventory control procedures written?
2 Does the program identify destruction dates for obsolete or
out-dated materials, components, and packaging materials?
3 Is stock rotated to ensure that the oldest approved product
or material is used first?
4 Is destruction of materials documented in a way that clearly
identifies the material destroyed and the date on which
destruction took place?
Vendor (Supplier) Control Program
1 Are vendors periodically inspected according to a written
procedure?
2 Is the procedure for confirming vendor test results written
and followed?

Question Instructions/Questions Yes/No/NA

Note any exceptions and comments in notebook
Operational Control
Material/Component/Label Verification, Storage, and Handling
1 Do written procedures identify storage time beyond which
components, containers, and closures must be
reexamined before use?
2 Is release of retested material clearly identified for use?
3 Are retesting information supplements originally obtained?
4 Do written procedures identify steps in the dispensing of
material for production?
5 Do these procedures include (1) release by QC, (2)
Documentation of correct weight or measure, and (3)
Proper identification of containers?
6 Does a second person observe
weighing/measuring/dispensing and verify accuracy with a
second signature?
7 Is the addition of each component documented by the
person adding the material during manufacturing?
8 Does a second person observe each addition of material
and document verification with a second signature?

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 9 Does a written procedure specify who is authorized to
issue labels?
10 Does a written procedure specify how labels are issued,
used, reconciled with production, returned when unused,
and the specific steps for evaluation of any discrepancies?
11 Do written procedures call for destruction of excess
labeling on which lot or control numbers have been
stamped or imprinted?
Equipment/Line/Area Cleaning, Preparation, and Clearance
1 Do written procedures detail how equipment is to be
checked immediately prior to use for cleanliness, removal
of any labels and labeling from prior print operations?
2 Do written procedures detail any disconnection and
reassembly required to verify readiness for use?
Operational Process Validation and Production Change Order Control
1 Have production procedures been validated? (Review
selected procedures for validation
documentation. Adequate?)
2 Does the process control address all issues to ensure
identity, strength, quality and purity of product?
3 Does the procedure include formulation that is written to
yield not less than 100% of established amount of active
ingredients?
4 Are all weighing and measuring performed by one qualified
person and observed by a second person?
5 Have records indicated preceding policy been followed by
presence of two signatures?
6 Are actual yields calculated at the conclusion of
appropriate phases of the operation and at the end of the
process?
7 Are calculations performed by one person? Is there
independent verification by a second person?
In-Process Inspection, Sampling, and Laboratory Control
1 Are written procedures established to monitor output and
validate the performance of manufacturing procedures
that may cause variability in characteristics of in-process
materials and finished drug products?

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 2 Are in-process materials tested at appropriate phases for
identity, strength, quality, purity and are they approved or
rejected by Quality Control?
3 Are there laboratory controls including sampling and
testing procedures to assure conformance of components,
containers, closures, in-process materials, and finished
product specifications?
Reprocessing/Disposition of Materials
1 Do written procedures identify steps for reprocessing
batches?
2 Are quality control review and approval required for any
and all reprocessing of material?
3 Does testing confirm that reprocessed batches conform to
established specification?
4 Does a written procedure outline steps required to
reprocess returned drug products (if it can be determined
that such products have not been subjected to improper
storage conditions?)
5 Does Quality Control review such reprocessed returned
goods and test such material for conformance to
specifications before releasing such material for resale?

Question Instructions/Questions Yes/No/NA

Note any exceptions and comments in notebook
Finished Product Control
Finished Product Verification, Storage, and Handling
1 Do written procedures indicate how and who verifies that
correct containers and packages are used for finished
product during the finishing operation?
2 In addition, do written procedures require that
representative sample of units be visually examined upon
completion of packaging to verify correct labeling?
3 Are expiration dates stamped or imprinted on labels?
4 Are expiration dates related to any storage conditions stated
on the label?

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 5 Are all finished products held in quarantine until QC has
completed its testing and releases product on a batch-to-
batch basis for sale?
6 Is finished product stored under appropriate conditions of
temperature, humidity, light, etc.
Finished Product Inspection, Sampling, Testing, and Release for
Distribution
1 Has the formulation for each product been tested for
stability based on a written protocol? (Containers must
duplicate those used in final product packaging.)
2 Are written sampling and testing procedures and acceptance
criteria available for each product to ensure conformance to
finished product specifications?
3 Is a quantity of samples equal to at least twice the quantity
needed for finished product release testing maintained as a
reserve sample?
4 Are sterility and pyrogen testing performed as required?
5 Are specific tests for foreign particles or abrasives included
for any ophthalmic ointments?
6 Do controlled release or sustained release products include
tests to determine conformance to release time
specification?
Distribution Controls
1 Does a written procedure manage stocks to ensure that
oldest approved product is sold first?
2 Are deviations to the policy above documented?
3 Does a written procedure identify the steps required if a
product recall is necessary?
4 Is the recall policy current and adequate?
Marketing Controls
1 The current regulation does not address marketing controls
per se except that all finished products must meet their
specifications.
Complaint Handling and Customer Satisfaction Program
1 Are complaints, whether received in oral or written form,
documented in writing and retained in a designated file?

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2 Are complaints reviewed on a timely basis by the Quality
Control Unit?
3 Is the action taken in response to each complaint
documented?
4 Are decisions not to investigate a complaint also
documented and the name of the responsible person
documented?
5 Are complaint investigations documented and do they
include investigation steps, findings, and follow-up steps, if
required? Are dates included for each entry?

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