2. Self Inspection
Introduction
• Principle:-
• To evaluate the manufacturer’s Compliance with GMP in all
aspects of production and Quality control.
• Designed to detect any shortcomings in the implementation of
GMP and to recommend the necessary corrective actions
• Performed routinely as well as on special occasions, e.g. in the
case of product recalls or repeated rejections
3. Cont…
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
4. Cont…………….
• Performed routinely
• Also on special occasions such as
Recalls
Repeated rejections
When a GMP inspection is announced by the
national drug regulatory authority
5. Cont…..
• The team should be led by an experienced person
• Procedure should be documented
• Effective follow-up programme (CAPA implemented)
6. Self Inspections/ Internal Audits
Performed in-house most often by a team and
involve people with different expertise
Could be carried out within a single facility or
organised by Head Office to be done over a range
of facilities
7. ITEMS OF SELF INSPECTION
• Personnel
• Premises including personnel
• facilities
• Maintenance of buildings and
• equipment
• Storage of starting materials and
• finished products
• Equipment
• Production and in-process controls
8. 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
9. Quality Audit
• This is an examination of all or part of quality system
• The aim is to improve it
• Usually conducted by outside experts or team
appointed by management
• Useful to supplement self-inspection programme with
quality audits
10. Types Of Quality Audit
• The quality audit system mainly classified
in three different categories:
i. Internal Audits
ii. External Audits
iii. Regulatory Audits
11. Purpose of Internal audit
• 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
12. Purpose of External Audit
• Confidence in the partnership arrangement
• Ensuring that requirements are understood
• Enabling reduction of in-house QC testing of starting
materials
• Reducing the risk of failure
13. Purpose of Regulatory audit
• Networking and confidence-building between
• national inspection authorities
• Development of quality systems
• Work towards global harmonisation of GMP
