This document discusses different types of audits conducted in the pharmaceutical industry. It describes internal audits that are conducted by a company's own staff to identify issues before external audits. External audits are conducted by customers or vendors to ensure quality systems are followed. Regulatory audits are performed by bodies like the FDA to ensure compliance with Good Manufacturing Practices (GMP). The document outlines the goals and procedures for conducting different types of audits in the pharmaceutical industry.

1. AUDIT AND ITS TYPES
Submitted by: Suhail ahmed
Submitted To: Dr. Neeraj Mishra
M.PHARMACY
DEPT. OF QUALITY ASSURANCE
I.S.F COLLEGE OF PHARMACY

2.  A systematic, independent and documented
process for obtaining evidence and evaluating
it objectively to determine the extent to which
criteria are fulfilled.
QUALITY AUDIT
 Quality audit is defined as a systematic and
independent examination to determine
whether activities and related results comply
with planned arrangements and whether
these arrangements are implemented
effectively and are suitable to achieve
objectives

3.  It is the audit related to Good Manufacturing
Practice in Pharmaceutical Industry
 Applying to national or international GMP
Regulations.
 It can be define as an audit conducted by
someone external to your organization with
the purpose of discovering GMP deficiencies.

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

5.  The quality audit system mainly classified in
three different categories:-
INTERNAL
AUDIT
EXTERNAL
AUDIT
REGULATORY
AUDIT

6.  Carried out by…….
1. Internal Audit
* Staff of section or
department of
company
OR
* Local Quality
assurance Group.
2. External Audit
•A company on its
vendors. Or
Sub contractors.
3. Regulatory Audits
Regulatory Bodies
*MCA (UK).
* USFDA(USA)

7. Internal (First Party) Audits:
 A key purpose of an internal audit is hopefully to
identify minor problems and errors before they
become a major issue or are discovered by a third
party.
 To Ensure that adequate Quality systems are
maintained.
 To asses compliance with the C-GMP’s and firms
standard
operating procedure.
 To achieve consistency between manufacturing and
testing
facilities.
 To identify problems internally and Correct problems
prior to a FDA inspection.

8. External Audit ( 2nd Party):-
 (A second party audit is one that is carried
out by a non-regulatory auditor).
 For example, in some industries, especially
pharmaceuticals and chemicals, customers
and potential customers will often ask to visit
a
company :-
 to ensure they are operating according to a
quality system and hence will provide good
quality goods

9.  A third party audit is one that is carried
out by a Regulatory auditor or Inspector.

10.  Networking and confidence-building between
national inspection authorities .
 Development of quality systems
 Work towards global harmonization of GMP.
 Carried out by regulatory bodies such as
MCA(U.K), USFDA (USA) for manufacturing
and supply of pharmaceutical product .
 Audits may be unannounced .
 Failure of regulatory audit withdrawal of a
manufacturing or import/export license.

11. 1. Assuring GMP compliance.
2. Detecting Potential Problems.
3. Effecting Programmed improvement
4. Increasing management
awareness.

12.  Dependant on the scope of the audit the audit
team can be composed of one or more auditors
 If there is more than one auditor a lead auditor
should be assigned and responsibilities should
be agreed .
 It is advisable to interchange auditors from time
to time for a given area in internal audits.
 Contact with the auditee should be made well in
advance of the audit to allow adequate time for
the necessary arrangements to be made, and
initial information gathering to take place.

13.  The audit should commence with an opening
meeting to introduce auditor(s) to relevant
auditee staff and Senior Management
Representative. (especially relevant for an
external audit or inspection).
 The opening meeting also provides an
opportunity to
 To explain the audit rationale
 clarify the audit plan.
 agree communication channels .
 clarify ambiguous replies in the pre-audit
questionnaire

14.  Analysis should be done with the deficiencies…….
 Deficiencies are classified as follows:-
1. Product Quality / Patient Safety Related deficiency
(Critical)
2. Significant cGMP Deficiency but with no direct
impact on Product Quality /Patient Safety (Major)
3. GMP deficiencies that are either considered to be
minor isolated examples or there is insufficient
information to classify them as
Major (Other)
 The auditee should be given the opportunity to clarify
and fully understand the evidence for the deficiencies

15.  It provides a record which identifies and may
be useful for prioritizing (e.g. Critical, Major,
Other) areas for improvement
 The audit report should be drafted, and the
final version issued, as soon as possible after
completion of the audit
 There are two important reporting phases:-
i) Preliminary reports during the audit
ii) Final report to the management

16.  Timely implementation of corrective actions, and
verification of their effectiveness
 It is a good reflection to the auditees
management is that 1st to start the major
remedial action as soon as possible.
 Followed by minor remedies.
 Major issues should be should be reported within
a agreed timeframe
 It may also be necessary to re-audit to ensure
that serious remedial action has been
satisfactorily completed for Critical or Major
deficiencies