ISPE Checklist

GMP Audit Checklist

YES,
QUE INSTRUCTIONS/QUESTIONS (NOTE ANY
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ON NOTEBOOK). OR
NA

1.0 General Controls

Does the facility and its many

departments (organizational units)
operate in a state of control as defined
by the GMP regulations?

Organizational & Management

1.1
Responsibilities

Does this facility/business unit operate

1.10
under a facility or corporate quality
1
policy?

211.22(a) Does a Quality Assurance

1.10
unit (department) exist as a separate
2
organizational entity?

211.22(a) Does the Quality Assurance

unit alone have both the authority and
responsibility to approve or reject all
1.10
components, drug product containers
3
and closures, in-process materials,
packaging materials, labeling and drug
products?

1.10 211.22 Does the QA department or unit

4 routinely review production records to
ensure that procedures were followed

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and properly documented?

211.22(b) Are adequate laboratory

1.10 space, equipment, and qualified
5 personnel available for required
testing?

If any portion of testing is performed by

a contractor, has the Quality Assurance
1.10 unit inspected the contractor's site and
6 verified that the laboratory space,
equipment, qualified personnel and
procedures are adequate?

1.10 Date of last

7 inspection:____________________

1.10 211.22(c) Are all QA procedures in

8 writing?

1.10 211.22(c) Are all QA responsibilities in

9 writing?

Are all written QA procedures current

1.11
and approved? (Review log of
0
procedures)

1.11 Are the procedures followed? (Examine

1 records to ensure consistent record-
keeping that adequately documents

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testing.)

211.25 Are QA supervisory personnel

1.11
qualified by way of training and
2
experience?

211.25 Are other QA personnel, e.g.,

1.11 chemists, analysts, laboratory
3 technicians) qualified by way of training
and experience?

211.22(a) Does the QA unit have a

person or department specifically
1.20 charged with the responsibility of
1 designing, revising, and obtaining
approval for production and testing
procedures, forms, and records?
211.22(d) Does a written SOP, which
identifies how the form is to be
1.20
completed and who signs and
2
countersigns, exist for each record or
form?
211.165(a)(b)(c) Is the production
batch record and release test results
1.20
reviewed for accuracy and
3
completeness before a batch/lot of
finished product is released?
Employee Orientation, Quality
1.3
Awareness, and Job Training
1.30 Circle the types of orientation provided
1 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

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performed (before the employee is
allowed to perform such tasks). (4)
Other: enter in notebook.
211.25(a) Does each employee receive
1.30 retraining on an SOP (procedures) if
2 critical changes have been made in the
procedure?
1.30 Indicate how on-going, periodic GMP
3 training is accomplished.
211.25 is all training documented in
writing that indicates the date of the
1.30
training, the type of training, and the
4
signature of both the employee and the
trainer?
211.25 Are training records readily
retrievable in a manner that enables
one to determine what training an
1.30
employee has received, which
5
employees have been trained on a
particular procedure, or have attended
a particular training program?
1.30 Are GMP trainers qualified through
6 experience and training?
211.25(a) Are supervisory personnel
instructed to prohibit any employee
who, because of any physical condition
(as determined by medical examination
1.30 or supervisory observation) that may
7 adversely affect the safety or quality of
drug products, from coming into direct
contact with any drug component or
immediate containers for finished
product?
1.30 211.28(d) Are employees required to
8 report to supervisory personnel any
health or physical condition that may
have an adverse effect on drug product

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safety and purity?

211.25(a) Are temporary employees

1.30
given the same orientation as
9
permanent employees?
211.34 Are consultants, who are hired
to advise on any aspect of manufacture,
1.31 processing, packing or holding, of
0 approval for release of drug products,
asked to provide evidence of their
education, training, and experience?
211.34 Are written records maintained
stating the name, address,
1.31
qualifications, and date of service for
1
any consultants and the type of service
they provide?
1.4 Plant Safety and Security
1.40 Does this facility have a facility or
1 corporate safety program?
1.40
Are safety procedures written?
2
1.40
Are safety procedures current?
3
Do employees receive safety
1.40
orientation before working in the plant
4
area?
Is safety training documented in a
readily retrievable manner that states
the name of the employee, the type of
1.40
training, the date of the training, and
5
the name of the trainer and the
signature of the trainer and the
participant?
1.40 Does this facility have a formal, written
6 security policy?
1.40 Is access to the facility restricted?

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QUE INSTRUCTIONS/QUESTIONS (NOTE ANY
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7
1.40 Describe how entry is
8 monitored/restricted:
1.40 Is a security person available 24 hours
9 per day?
1.5 Internal Quality/GMP Audit Program
1.50 Does this business unit/facility have a
1 written quality policy?
1.50 Is a copy of this quality policy furnished
2 to all employees?
1.50 If "yes" to above, when provided?
3 __________________
1.50 Is training provided in quality
4 improvement?
1.50 Does a formal auditing function exist in
5 the Quality Assurance department?
Does a written SOP specify who shall
1.50 conduct audits and qualifications
6 (education, training, and experience) for
those who conduct audits?
Does a written SOP specify the scope
1.50
and frequency of audits and how such
7
audits are to be documented?
1.50 Does a written SOP specify the
8 distribution of the audit report?
1.6 Quality Cost Program
1.60 Does this facility have a periodic and
1 formal review of the cost of quality?
Does this facility have the ability,
1.60 through personnel, software, and
2 accounting records, to identify and
capture quality costs?
1.60 Does this facility make a conscious
3 effort to reduce quality costs?

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