Professional Documents
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Self-Inspection
Module 7
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WHO - EDM
Self-Inspection
Objectives
Module 7
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WHO - EDM
Self-Inspection
Principle - I
Should
cover all aspects of production and quality control
be designed to detect shortcomings in the implementation
of GMP
Must
recommend corrective action if shortcomings are observed
set a timetable for corrective action to be completed
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WHO - EDM
Self-Inspection
Principle - II
Special occasions may demand additional selfinspections. For example
Recalls
Repeated rejections
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WHO - EDM
Self-Inspection
Principles III
No conflict of interest
No revenge in mind
Should have experience as observers of a selfinspection team before becoming team member
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WHO - EDM
Self-Inspection
1. Self-inspection - informal
(daily)
Immediate Correction
2. Self-inspection - formal
(quarterly)
3. QC - Internal
Improve systems
Confirm compliance
(half yearly)
Module 7
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WHO - EDM
Self-Inspection
Scope of Self-Inspection Programme - I
Written instructions
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
Part One 9.2
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WHO - EDM
Self-Inspection
Scope of Self-Inspection Programme - II
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
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WHO - EDM
Self-Inspection
The Self-Inspection Team
Module 7
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WHO - EDM
Self-Inspection
Carrying Out a Self-Inspection
Frequency
May depend on company requirements and the size of the
company
Report:
results
evaluation
conclusions
recommended corrective measures, if applicable
Follow-up action
Company management must evaluate both
the report and corrective actions
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WHO - EDM
Self-Inspection
Quality Audit
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WHO - EDM
Self-Inspection
Suppliers audits
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WHO - EDM
Self-Inspection
Auditing the Self-Inspection Programme
-I
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WHO - EDM
Self-Inspection
Auditing the Self-Inspection Programme - II
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WHO - EDM
Self-Inspection
Auditing the Self-Inspection Programme
- III
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WHO - EDM
Self-Inspection
Group Session
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WHO - EDM
Self-Inspection
Possible Issues
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WHO - EDM