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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