SELF INSPECTION-(Quality Audit)

Really..????

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Introduction

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Definitions

A. Self Inspection : method to re-check your (own

dept) assignment and work done by you.

B. Internal Audit :
➢ Will be carried by two different department.

➢ Independent & objective functional activity, give

management advise.

➢ Specific department in same organization.

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Principle (1)
 Purpose of self-inspection is to evaluate whether a
company’s operations remain compliant with GMP

 Assists in ensuring quality improvement

 The programme should

cover all aspects of production and quality control
be designed to detect shortcomings in the implementation of
GMP
recommend corrective actions
set a timetable for corrective action to be completed
Principle (2)

 Performed routinely

 Also on special occasions such as

Recalls
Repeated rejections
When a GMP inspection is announced by the national
drug regulatory authority
Principle (3)
 Self-inspection team should consist of personnel who:
can evaluate the situation objectively
have no conflict of interest, have no revenge in mind
should have experience as observers of a self-inspection
team before becoming a team member
can be lead self-inspector with experience as team member

 Procedure should be documented

 Effective follow-up programme

Self Inspection Aspects
1. Personnel

2. Building include facilities

3. Maintenance buildings and equipment

4. Storage (RM,PM & FG)

5. Equipments

6. Production & IPC

7. Quality Control

8. Documentation
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Continues..
9. Sanitation & Hygiene

10. Validation

11. Calibration Instrument

12. Recall Procedure

13. Complaints Management

14. Controls of labels

15. Result of previous self inspection & any corrective steps

taken.
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Definitions
1. Auditor : executor

2. Auditee : object

3. Lead Auditor : team leader

4. Minor finding

5. Major finding

6. Critical finding

7. CAPA : Corrective Action & Preventive Action

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Classification
a) Critical: A deficiency which has produced, or may result in a
significant risk of producing, a product which is harmful to the
intended user.

b) Major: A deficiency which has produced or may produce which

does not comply with its marketing authorization/specifications;
and/or indicates a major deviation from the regulation or
standard.

c) Minor: A deficiency which cannot be classified as either critical

or major, but which may indicate a departure from GMP.

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Organization
Plant Manager

QA Manager

Lead Auditor

Auditor Member Auditor Member Auditor Member

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Lead Auditor
Responsibilities :

1. To manage team

2. Make audit planning

3. As team representative

4. Make final report

5. Lead audit meeting

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The Self Inspection Team
Team appointed by management, with:
authority
sufficient experience
may be from inside or outside the company
experts in their own field
familiar with GMP
Schedule

A complete self inspection, should be

conducted at least once a year.

The frequency should be stated in the

procedure for self inspection

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Report
A report should be made at the completion of
self inspection.

The report should include :

➢ Result

➢ Evaluation & conclusion

➢ Recommended corrective action

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Quality Audit

A quality audit is an examination of all or part

of quality system with specific aim of improving
it
 Usually conducted by outside experts or team
appointed by management

 Useful to supplement self-inspection programme with

quality audits

 May be extended to suppliers and contractors