This is pharmacy bossiness

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