The document outlines the framework and purpose of conducting audits within organizations, particularly focusing on the pharmaceutical sector. It details different types of audits, their objectives, and the audit process, emphasizing the importance of evaluating compliance with established standards and improving quality management systems. Key components of audits, methods of information gathering, and the responsibilities of the auditing team are also discussed.

1. 1
By :
L. KIRAN KUMAR
M PHARMACY
A U College of Pharmaceutical Sciences
GOOD LABORATORY PRACTICES
AUDIT

2. Contents :
• Audit
• Introduction
• Objectives
• Goals of an audit
• Types of audits
• Components of audit
• Audit process
• References
2

3. 3
Audits are conducted to ascertain the validity and reliability of the
information; also to provide an assessment of the internal control of
a system.
The audit in simple terms could be defined as the inspection of a
process or a system to ensure that it meets the requirements of its
intended use.
Audit
INTRODUCTION

4. 4
• Evaluating conformity of requirements to ISO 9001
• Evaluating conformity of documentation to ISO 9001
• Determining effectiveness in meeting requirements and objectives
• Providing an opportunity to improve the quality management system
Objectives
• The simple goal of this complex process is to evaluate existing activities
and documentation and determine if they meet the established standards.
• An audit will evaluate the strengths and weaknesses of quality control
and quality assurance processes, the results of which will help us to
improve processes and build a better system for the benefit of the
company.
Goals of an audit

5. 5
Internal Audits
 This type of audit is also known as First-Party Audit or self-audit. Those auditing and those being audited all belong to the
same organization.
 Internal audit is a professional activity that consists of advising organizations on how to achieve their goals in a better way.
Types of audits
Internal Audits External Audits
Regulatory
Audits

6. 6
 This type of audit is also known as Second-Party Audit.
It refers to a customer conducting an audit on a supplier
or contractor.
 Although there are no strict legal requirements for this
control. It is always advisable to evaluate the
competence of the contractors in which we produce our
products or carry out the analysis of our products or any
other activity according to GMP.
External audits
Regulatory audits
 This type of audit is also known as Third-Party
Audit.
 Neither customer nor supplier conducts this type
of audit.
 A regulatory agency or independent body
conducts a third-party audit for compliance or
certification or registration purposes.

7. 7
Components
of audit
Risk Assessment
• identifies relevant risk
factors that challenge an
organizational area and
further considers their
relative significance.
Scope Statement
• identifies the activities
that will be covered
during the course of the
audit.
Audit Program
• Audit Program is the
document that contains
the listing of audit
procedures as well as the
objectives of the audit. Audit Procedures
• Audit Procedures are the
specific tasks that the
auditor follows to gather,
analyze, and document
during the audit.
Workpapers
• Workpapers are the
detailed documentation
from interviews and
testing that conducted to
complete the audit
program.

8. 8
Methods of gathering audit
information
• Interviews
• Inspections
• Reviewing documents
• Observations
• Exercises
• Vertical tracking

9. 9
Composition of the auditing team
with clarity on their authority and
responsibility
Information regarding the
company policy pertaining to
auditing.
Standard
Operating
Procedures
for Auditing
A pharmaceutical company has to
prepare a standard operating
procedure for auditing which
includes the following points:
1
2
Statement of purpose scope
of audits 3 Chosen areas subjected
to auditing 4
Frequency of auditing
7
5
6
Written reports on audits
including their distribution
Corrective action

10. 10
Planning
• Audit notification
• Gathering information
• Identify risks
• Create audit program
Field work
• Conduct interviews
• Review documentation and processes
• Test transactions and documentation
Reporting
• Provide draft report for comments
• Obtaining corrective action plans
• Distribution of final report
Follow up
• Review new processes and documentation
• Re-audit
Opening meeting Discuss planned audit
Final meeting
Discuss audit
results
Discuss corrective
action plans
Audit process

11. 11
References:
1. https://www.researchgate.net/publication/330261216_Pharmaceutical_quality_audits_A_review
2. https://www.alghad.edu.ly/control_panel/books/the%20role%20of%20regulatory%20GMP%20audit%20in
%20pharma%20companies.pdf
3. https://www.researchgate.net/publication/263657405_A_review_on_audits_and_compliance_management
4. Establishing a cGMP Laboratory Andit System, A Practical Guide - David M Bleisner Wiley

12. 12
THANK YOU