1. A seminar on,
Introduction to Audit
Submitted to
Savitribai Phule Pune University ,
In Partial fulfilment of Requirements for the Award of
Degree of
MASTER OF PHARMACY
IN
PHARMACEUTICAL QUALITY ASSURANCE TECHNIQUES
Bhujbal Knowledge City,
MET’S Institute of Pharmacy,
Adgaon, Nashik.
2018-2019
Presented by-
Mr. Sanket D. Pawar.
M.Pharm (PQAT)
Sem II
Guided By-
Prof. J. B. Ugale
2. CONTENTS
• Types of Audit :
• Objectives :
• Management And Planning :
• Responsibilities of Auditor :
• Deficiencies :
• References :
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3. 1. Types of Audits :
• Internal Audit : This is conducted within the premises to
monitor the implementation of cGMP. Helps in taking
necessary corrective and preventive measures.
• External Audit: This is conducted for the suppliers or
any outsourcing operations. The contract giver is
responsible to access the competence of the Contract
acceptor as per the GMP guidelines.
• Rationale for Conducting Internal and External Audit as
per ICH Guidelines Q10:
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4. 2. Objectives of Audits :
1.Ensure that companies operations remain compliance
with and implements cGMP.
2. Ensures continuous quality improvement and Cover all
corrective aspects in production and quality control.
4. Establish and maintain a state of control.
5. To determine the conformity or non-conformity of the
quality system in meeting the specified requirements.
6. To determine the effectiveness of the implemented quality
in meeting the specified Quality objectives. 4
5. 3. Management And Planning :
3.1. Introduction :
To achieve its objectives efficiently and cost-
effectively an audit should be thoroughly planned. Clear
and effective communication should be done.
3.2. Pre-Audit Information :
The collection and analysis of information is
essential for successful planning. It is important to clearly
establish the reason for performing the audit (e.g. new
supplier, etc.) in order to determine the type of the audit. 5
6. 3.3. Preparation :
Dependant on the scope of audit, team can be
composed of one or more auditors. Specialist(s) can be
added when necessary. The agenda for the audit should be
communicated to the auditee. The auditors should be
aware of any sensitive issues, for example Highly
Confidential information.
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7. Opening
Meeting
• It is to introduce auditor(s) to relevant auditee staff
and senior management Representatives.
Brief
Tour
• In order to familiarize with the size and complexity
of the operation.
Main
Audit
• Performing actual tests in audit.
Closing
Meeting .
• To communicate the audit findings and conclusions
to the auditees management.
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3.4. Performing the Audit :
8. 3.5. Reporting the Audit and Auditee Response :
Audit report is most important. It provides a record
which identifies and may be useful for prioritizing areas
for improvement.
3.6. Follow Up Of Progress with Remedial Actions :
The timely implementation of corrective actions, and
verification of their effectiveness, is essential to the
concept of continuous improvement.
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9. 4. Responsibilities of Auditor :
• Auditor’s job involves researching and ensuring
necessary corrective measures.
• A pharmaceutical auditor will establish the best internal
control system for costing.
• Should suggest and implement necessary corrective
measures to ensure best practices. i.e to Comply with
cGMP , GCP, GLP.
• Auditor should cover all corrective aspects in plant.
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10. 5. Information Gathering :
• A major source of information is the pre-audit
questionnaire which, if well constructed can be an
extremely valuable tool if responses are analyzed
carefully.
• Experience of previously received product.
• Previous audit reports are another valuable source of
information.
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11. 6. Classification of deficiencies :
• Critical : Patient Safety Related deficiency. It may
directly affect the patient health.
• Major : Significant cGMP Deficiency but with no direct
impact on Product Quality and Patient Safety
• Other : GMP deficiencies that are either considered to be
minor isolated examples or there is insufficient
information to classify them as Major.
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