Presented By: Dolita K. ShahAssistant 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 fulfiltechnical 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

RegulatoryCustomer, or

potential customer

Third party (on behalf of

customer)

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(B) Performed by manufacturer

(i) Internal (self-inspection)

(ii) External

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Internal (self-inspection)

• Overall• Departmental• Product-orientated• System-orientated

External

• supplier• contract manufacturer• contract packager• 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 announce

Arrive at site of audit, meet, explain

purpose

Perform audit

Informal oral report of finding

Formal report, with recommendations

Follow-up

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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 plan22

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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