Self-Inspction and quality audits.ppt

Self-Inspection and quality audits
Basic Principles of GMP
Self-Inspection
Objectives
To identify the role of self-inspection in the quality management system
To review the way in which a self-inspection programme should be carried out
To discuss what to inspect and verify in pany’s self-inspection system
Self-Inspection
Principle (1)
Purpose of self-inspection is to evaluate whether pany’s operations pliant with GMP
Assists in ensuring quality improvement
The programme should
cover all aspects of production and quality control
be designed to detect ings in the implementation of GMP
mend corrective actions
set a timetable for corrective action to pleted

Self-Inspection
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

Self-Inspection
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 ing a team member
can be lead self-inspector with experience as team member
Procedure should be documented
Effective follow-up programme

Self-Inspection
1. Self-inspection - informal
(daily) Immediate correction
2. Self-inspection - formal
(quarterly) Improve systems
3. QC - Internal pliance
(half-yearly)

Self-Inspection
Items for Self-Inspection (1)
Written instructions provide minimum and uniform standard
Covering all aspects of GMP:
personnel
premises including personnel facilities
maintenance of buildings and equipment
storage of starting materials and finished products
equipment
production and in-process controls
quality control

Self-Inspection
Items for Self-Inspection (2)
documentation
sanitation and hygiene
validation and revalidation programmes
calibration of instruments or measurement systems
recall procedures
complaints manage