Self inspections are performed routinely and on special occasions to evaluate a manufacturer's compliance with Good Manufacturing Practices (GMP) and detect any shortcomings. The inspections are designed to cover all aspects of production and quality control and recommend corrective actions. They should be led by an experienced person, documented, and include an effective follow-up program to ensure corrective actions are completed. Quality audits supplement self-inspections and can be internal, external, or regulatory to further improve quality systems.

2. Self Inspection
• 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