1. Context of Observation
During the WHO GMP inspection of AABBCC Pharmaceutical Plant, the inspection team observed that unauthorized personnel were able to enter the manufacturing area without appropriate authorization and documented access control. The observation indicated weaknesses in the implementation of the site’s access control system for GMP manufacturing areas.
The investigation confirmed that:
- An SOP governing personnel entry and gowning was available.
- Authorized personnel lists had been established.
- Access-controlled manufacturing areas were identified.
- Visitor entry procedures were documented.
However, implementation was not consistently effective. Deficiencies identified included:
- Inadequate verification of personnel authorization before entry.
- Incomplete access log documentation.
- Insufficient supervision during shift changes.
- Lack of periodic review of access permissions.
- Inadequate monitoring of contractor and visitor access.
- Failure to promptly deactivate access rights of personnel whose authorization had changed.
Although no evidence of deliberate GMP violations or product contamination was identified, the observed practice represented a significant weakness in the facility’s contamination control strategy and personnel management system
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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AUDIT COMPLIANCE REPORT FOR UNAUTHORIZED ACCESS TO MANUFACTURING AREA
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