Self Inspections

Basic Principles of GMP
Self-Inspection and
quality audits
Module 7
Slide 1 of 17
January 2006
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 a companys selfinspection system
Module 7
Slide 2 of 17
January 2006
Self-Inspection
Principle (1)
Purpose of self-inspection is to evaluate whether a companys
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
8.1
recommend corrective actions
set a timetable for corrective action to be completed
Module 7
Slide 3 of 17
January 2006
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
8.1
Module 7
Slide 4 of 17
January 2006
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 becoming a team member
can be lead self-inspector with experience as team member
Procedure should be documented
Effective follow-up programme
8.1
Module 7
Slide 5 of 17
January 2006
Self-Inspection
1. Self-inspection - informal
(daily)
2. Self-inspection - formal
(quarterly)
Slide 6 of 17
Improve systems
Confirm compliance
3. QC - Internal
(half-yearly)
Module 7
Immediate correction
January 2006
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
8.2
Module 7
Slide 7 of 17
January 2006
Self-Inspection
Items for Self-Inspection (2)
documentation
sanitation and hygiene
validation and revalidation programmes
calibration of instruments or measurement systems
recall procedures
complaints management
labels control
results of previous self-inspections and
any corrective steps taken
Module 7
Slide 8 of 17
January 2006
8.2
Self-Inspection
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
Frequency should be at least once a year
May depend on company requirements
Size of the company and activities
Module 7
Slide 9 of 17
January 2006
8.3, 8.4
Self-Inspection
Carrying Out a Self-Inspection
Report prepared at completion of inspection, including:
results
evaluation
conclusions
recommended corrective measures
Follow-up action
Effective follow-up programme
Company management to evaluate both
the report and corrective actions
Module 7
Slide 10 of 17
January 2006
8.5, 8.6
Self-Inspection
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
8.7
Module 7
Slide 11 of 17
January 2006
Self-Inspection
Suppliers audits and approvals
QC department should have responsibility together with other
relevant departments for approving suppliers
Ensures suppliers can reliably supply materials that meet
established specifications
Suppliers should be evaluated and approved before they are

included in approved supplier's lists
8.8, 8.9
Should take into account the suppliers history and nature of

materials to be supplied
Evaluation may also lead to an audit to assess compliance, e.g.
with GMP
Module 7
Slide 12 of 17
January 2006
Self-Inspection
Auditing the Self-Inspection Programme (1)
Check self-inspection programme at end of formal government
GMP inspection, not at beginning
GMP inspectors should assess:
the SOP
programmes
checklists or aide-mmoires
Module 7
Slide 13 of 17
January 2006
Self-Inspection
The SOP should describe teams, process, items covered, and
the frequency of self-inspection
Company policy may not permit GMP inspector to see actual

deficiency reports and corrective actions
GMP Inspectors should be looking for compliance with the selfinspection SOP - not necessarily at actual deficiencies
recorded
Seek objective evidence of reports and action
Module 7
Slide 14 of 17
January 2006
Self-Inspection
Ensure company is not just doing housekeeping or safety
audits
Check there are Vertical as well as normal Horizontal
audits; both play valuable role in self-inspection
Module 7
Slide 15 of 17
January 2006
Self-Inspection
Group Session
You are a GMP inspector in a large company with a diverse
range of products
You are given the SOP, deficiency report form, and the selfinspection schedule
Prepare a report of your observations as to whether the

companys approach to self-inspection meets GMP guidelines
Module 7
Slide 16 of 17
January 2006
Self-Inspection
Possible Issues
Size of the factory; phased inspection
Source of team leader

Source of team members
Reports and feedback
Module 7
Slide 17 of 17
January 2006

Self Inspections

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Basic Principles of GMP

The programme should

Usually conducted by outside experts or team appointed by

Suppliers should be evaluated and approved before they are

Should take into account the suppliers history and nature of

Company policy may not permit GMP inspector to see actual

Prepare a report of your observations as to whether the

Size of the factory; phased inspection

Source of team leader

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