focused on audit done by regulatory agencies.

1. Auditing of manufacturing facilities
by International regulatory
agencies.
Presented by:- Tek Chand
M. pharm(DRA)
AMITY UNIVERSITY (NOIDA)

2. AUDITS
• A systematic, independent and documented process for
obtaining evidence and evaluating it objectively to
determine the extent to which criteria are fulfilled.
TYPES OF AUDITS :
 There are 3 types of Audits –
• Product audit – An examination of a particular product or
service.
• Process audit – A verification that processes are working
within established limits.
• System audit – An audit conducted on a management
system.

3. The audit system mainly classified in three
different categories:-
1) Internal Audit
2) External Audit
3) Regulatory Audit

4. 2. External Audit
•A company on its
vendors. Or
Sub contractors.

5. Regulatory Audit
• A regulatory audit is one that is carried out by a
Regulatory auditor or Inspector.
• These are a legal requirement in highly regulated
industries such as pharmaceuticals and food production

6. Purpose of Regulatory Audits.
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.

7. • After regulatory audit, a formal report will be
delivered
For MCA :- verbal feedback report is given
at the exit meeting.
For USFDA :- Provides “Form 482” as
Inspection Notice.
Provides “Form 483” at the exit meeting.

8. AUDIT PROCESS:-
1) Notice of Inspection – The Inspector give the
notice of inspection , if it is unannounced then
you are presented with FORM 482.
2) The form 482 clearly states what an inspector
may inspect.
# An inspector may enter, observe, collect samples,
interview employees, and review any records
related to the production of the regulated product.
# An inspector cannot demand access to personnel
data (except training records), financial statements,
sales data (except shipment data), pricing data, or
research records

9. Audit Report
• 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.

10. Preliminary reports during the audit:-
1. Benefits can be gained from having dialogues
with employees.
2. Finding is communicated with affected
personnel.
3. Discussion may help the employees to learn
why problems happened.

11. Final report to the management:-
 Management must review the final reports and
determine what steps need to be taken to eliminate
deficiencies .
 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.

13. THANK YOU