M.Pharm, 1st Sem Seminar
Sub - DRA & IPR
Topic - Quality Audit
Presented by - Satyaki Aparajit Mishra
Regd No - 1561611001
School of Pharmaceutical Sciences,
Quality audit means a systematic examination of
a quality system.
Quality audits are typically performed at defined
Any failure in their proper implementation may be
published publicly and may lead to a revocation of
Objectives  :-
Pharmaceutical manufacturers commonly use audits
as an effective mechanism to verify compliance with
Audits can be used to establish a high degree of
confidence to remain under an adequate level of
control by managements.
Audits are intended to verify that manufacturing and
Control systems are operating under a state of control.
Designed to detect any shortcomings in
the implementation of GMP and to
recommend the necessary corrective
Performed routinely as well as on
special occasions, e.g. if any complaint
arises or repeated rejections occur
Self Inspection Team :-
Management appoints a team from the
staff or from outside having competent
knowledge to carry out the inspection.
The team can detect any shortcomings
in the implementation of GMP and
recommends necessary corrective
Generally, people with expertise in the
field of QA/QC, manufacturing and
production parameter, & inventory
control are chosen.
Frequency of Self inspection :-
Depends on the basis of the requirement of the
Sometimes, carried out partially or completely
but a complete inspection must be done at least
once a year.
In addition, it is carried out on special events like
product recall, repeated rejections or sudden
announcement of inspection by authorities.
Items for Self Inspection :-
• Premises including personnel facilities
• Maintenance of buildings & equipment
• Quality Control
• Sanitation and hygiene
• Validation and revalidation programmes
• Recall procedures
• Complaints management
• Labels control
Inspection of at least following items must be done
as prescribed by the WHO text of GMPs :-
Simple, convenient and
easy to use for any
desired subjected area.
Questions are in logical
order that help auditor
to detect problems.
Report can be prepared
in a minimum amount
Management must review the final reports and
determine what steps need to be taken to eliminate
Management should sincerely encourage detection of
problems and express appreciation for being able to
improve quality operations.
The audit reports may be shared with manger
supervisor who may discuss finding with employees.
The workers and supervisory personnel should be given
the opportunity to explain their views and ideas about
the audit findings.
Final report to the management  :-
1. Sharma P.P ; How to Practice GMPs , 6th Edition (2010)
Page 99-114 
2. Pharmaceutical Quality Group; Monograph no :- 5 (revised):
Pharmaceutical Auditing ; IQA2001, ISBN 0906810 68X 
3. Provisional Guideline ON the inspection of the
pharmaceutical manufacturers in: WHO Expert committee on
specification for Pharmaceutical Preparations; 32nd report,
Geneva, WHO, 1992, Annex-2 (Who technical report series.
No :- 823)