This document provides an introduction to auditing and the audit process. It defines an audit as the on-site verification of a process or quality system to ensure compliance. Audits can be conducted internally or externally according to ICH guidelines. The objectives of an audit are to determine conformity or nonconformity with quality systems and to improve quality. Pharmaceutical manufacturers use GMP audits to verify manufacturing controls and permit timely problem correction. Management audits comprehensively examine an organization. Audits can be first, second, or third party. An auditor's responsibilities include providing audit reports and identifying issues. The planning process for an audit involves announcing a schedule, conducting meetings, performing the audit, and providing follow-up.

1. Presented by:
Nikita Bajarang Amane.
M. Pharmacy
1st year
(Quality Assurance)
Rajarambapu college of Pharmacy Kasegaon
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2. Introduction of 'Audit'
Definition:
Auditing is the on-site verification activity, such
as inspection or examination, of a process or quality
system, to ensure compliance to requirements. An audit
can apply to an entire organization or might be specific
to a function, process, or production step.
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4. Rationale for Conducting Internal and External Audit as per ICH
Guidelines Q10:
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5. Objective
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To determine CONFORMITY or NON CONFORMITY of
the Quality System.
To determine the EFFECTIVENESS OF IMPLEMENTED
SYSTEM in meeting specified quality objectives
To afford an APPORTUNITY TO IMPROVE Quality system
To provide Manages with INFORMATIONS

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Pharmaceutical manufacturers commonly use audits as
an effective mechanism to verify compliance with GMP
regulation (GMP).
GMP audits with two important goals
1. Audis are intended to verify that manufacturing and Control
systems are operating under a state of control.
2. Audits permit timely correction of potential problems.
3. Audits can be used to establish a high degree of confidence to
remain under an adequate level of control by managements

8. Management
Management audit.
“The Management Audit may be defined as a
comprehensive and constructive examination of an
organization structure of a company, institution or
branch of Government, or of any component thereof,
such as a division or department, and its plans and
objectives, its means of operation and its use of
human and physical facilities.”
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Management of Audits Involve
1.First Party Audit
2.Second Party Audit
3.Third Party Audit

10. Responsibilities of an Auditor
1. Provide An Audit Report
A qualified opinion – this states that the financial
statements give a true and fair view of the company’s state of
affairs except for certain stated circumstances;
A disclaimer of opinion– this states that the auditor is
unable to form an opinion as they were unable to gather
a sufficient amount of competent evidence; and
An adverse opinion – this states that the financial
statements do not give a true and fair view.
2. Report Failure To Maintain Proper Books Of Account
3. Duty To Report Indictable Offences
4. Duty To Exercise Professional Integrity
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11. The Planning Process
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Plan & Arrange
The audit
Announce The Schedule
of Audit
Arrive or Visit At the
Site of Audit
Conduct an
Meeting
Perform actual
Audit
Informal and Oral
instructions
Formal Report And
Recommendation
Follow up the
Instructions Given By
the Inspectors

12. Planning Process
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13. References
ISO 9001-2008 Audit
www.accountingnotes.net/auditing/management-
audit/management-audit-definition-meaning-and-fundamental-
concepts/5049
 www.corplaw.ie/blog/bid/337442/The-Responsibility-Of-Auditors
 smallbusiness.chron.com/planning-process-audit-10354
 smallbusiness.chron.com/sixstep-audit-process-17816
This Compliance Audit Handbook has been produced by the
Compliance and Assurance Section of the Department of
Environment and Conservation NSW (DEC).
Responsibilities and Functions of the Independent Auditor Source:
SAS No. 1, section 110; SAS No. 78; SAS No. 82.
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