Presented By: Dolita K.

Shah
Assistant Professor
(M.Pharm –Q.A, Gold Medalist)
Smt R. B. Patel Mahila Pharmacy College
Atkot

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 A systematic and independent examination to
determine whether quality activities and related
results comply with planned arrangements, and
whether these arrangements are implemented
effectively and are suitable to achieve objectives

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 To collect objective evidence to permit an informed
judgment about the status of the systems or product
being audited

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 Internal (First Party, Self)

 This type includes audits by company employees,

consultants and contractors

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 External
i. Supplier Audit
○ Second Party
 Customer employee(s) audit your company
or
 Your employee(s) audit a company which
supplies your company with a product or
service

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ii. Independent Organization

 Third Party Audit

○ A customer wants an audit of your company

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1. Compliance (do we comply with the standard)
 Example: Desk audit of high level systems
2. System (the theory)
 Example: Audit of Document Control
3. Process (the practice)
 Example: Audit of any process (manufacturing)
4. Product (the result)
 Example: Audit of finished products to fulfil
technical specifications

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1. Auditor: A person who has appropriate qualifications
and performs audits.

2. Client: A person or organization requesting the audit.

For internal audits, this is the Management
Representative.

3. Auditee: An organization, facility or person being

audited.

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4. Quality System: The organizational structure,
responsibilities, procedures, processes and
resources for implementing quality management.

5. Observation: A statement of fact made during an

audit and substantiated by objective evidence.

6. Nonconformity: The non-fulfillment of specified

requirements.

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7. Objective Evidence: Qualitative or quantitative
information, records or statements of fact pertaining
to the quality of an item or service or to the
existence and implementation of a quality system
element, which is based on observation,
measurement or test and which can be verified.

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 (A) Imposed upon
manufacturer or
supplier

Third party (on

Customer, or
Regulatory behalf of
potential customer
customer)

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 (B) Performed by
manufacturer

(i) Internal (self-

(ii) External
inspection)

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 Internal (self-
External
inspection)
• Overall • supplier
• Departmental • contract manufacturer
• Product-orientated • contract packager
• System-orientated • Of contract
warehouse/distributor

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• Determine the level of compliance
• Build confidence (hopefully) in GMP and the QA system
• Build interdepartmental trust, understanding, and communication
(if the audit is done properly and tactfully)
• Determine measures necessary to improve, e.g.,:
• Premises, equipment, environment
• Operations, actions, procedures
• Personnel/training
• Provide a stimulus for improvement
• Recommend corrective action
• Monitor improvement
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• Establish and monitor capability of supplier or
contractor to deliver
• goods and services that are fit for purpose (and on
time, and in the quantity required)
• Build mutual confidence
• Promote understanding and communication
between the parties involved (both sides can learn!)
• And in general, as listed for “internal”

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 Plan and
prepare

Arrange and
Follow-up
announce

Arrive at site of
Formal report, with
audit, meet, explain
recommendations
purpose

Informal oral
Perform
report of
audit
finding
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examination of

1. established methods

2. instructions

3. work flow for processes

4. maintenance programs for production equipment

5. material handling

6. housekeeping around the work area

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 Here company’s procedures are validated
 Processes are sub-parts of a system.
 Process audits are generally a part of larger system(s)
audit.
 However , they can be performed independently
○ An internal audit may indicate need to perform a specific
process audit
 Almost always, one or more other process(es) will interact
with any given process.
 One very important issue to consider is the effectiveness of
communications between systems and/or processes.
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Inter-relation between different processes

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1. Documents
a. Quality and GMP regulations, standards, and guidelines
(local, national, and international)
b. Previous audit and follow-up reports
c. Auditee’s own documents and records
d. Audit checklists
 requires that auditor evaluates a certain number of
procedures, plans and documents
2. The auditors own eyes, ears, brain, words, character, etc.
3. The auditing plan
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1. Is there a documented sanitation program?
2. Are the specifics of the program followed?
3. Are there standard operating procedures (SSOPs)?
4. Is a pre-operational audit conducted prior to production?
5. Are corrective actions taken in response to pre-op
findings?
6. What are the general conditions in the plant?
7. Are the floors, walls and ceilings in good condition?
8. Are the exterior structure and grounds maintained in a
condition to prevent contamination?

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