Question |
Instructions/Questions |
Yes/No/NA |
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? |
|
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 |
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 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 |
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? |
|
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 |
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 |
|
|
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? |
|
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 |
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? |
|
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 |
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? |
|
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? |
|
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 |
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? |
|
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? |
|
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 |
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? |
|
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? |
|
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 |
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? |
|
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? |
|
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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