During the WHO GMP inspection of a pharmaceutical plant, Name AABBCC, an observation was made that AUDIT COMPLIANCE REPORT FOR CHANGE CONTROL SYSTEM NOT PROPERLY IMPLEMENTED. This has been received.
The compliance report along with supporting documents is to be submitted within 30 days.
Context of Observation
During the WHO GMP inspection conducted at AABBCC pharmaceutical manufacturing facility, the following observation was raised:
“Trend analysis of deviations not performed.”
Although an approved SOP for Deviation and Incident was available within the Pharmaceutical Quality System (PQS), it was observed that systematic trend analysis of deviations was not performed periodically to identify recurring failures, systemic weaknesses, or adverse quality trends.
The inspection team observed the following deficiencies:
- Periodic deviation trend analysis reports were unavailable.
- Repeat deviations were not scientifically trended or categorized.
- No statistical or risk-based evaluation of recurring deviations was performed.
- Trending data was not reviewed during management review meetings.
- CAPA effectiveness was not evaluated using trend analysis.
- No alert/action limits were established for recurring deviations.
- Cross-functional review of deviation trends was inadequate.
This observation indicates weakness in the monitoring and continuous improvement elements of the Pharmaceutical Quality System.
2. Root Cause Analysis (Detailed)
A detailed investigation was conducted using the 6M (Ishikawa) methodology.
2.1 Man (Personnel)
- Personnel lacked adequate understanding of:
- Statistical trending methodology
- GMP expectations for deviation trending
- Risk-based trend evaluation
- Responsibilities for preparation and review of deviation trends were not clearly assigned.
- Inadequate QA oversight regarding periodic trend review.
2.2 Method (Procedure/System)
No standardized deviation trend report format existed.
Existing SOP lacked:
Defined trend analysis frequency
Statistical evaluation criteria
Alert/action limit requirements
Escalation process for recurring trends
Trending methodology for repeat deviations
Key Parameter of the Below Page:
Audit Compliance Report
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Audit Compliance Report
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Audit Compliance Report
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Audit Compliance Report
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Audit Compliance Report
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Audit Compliance Report
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Click the link to download word file copy of this document:
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Audit Compliance Report
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Audit Compliance Report
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Audit Compliance Report
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Audit Compliance Report
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Audit Compliance Report
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Click the link to download word file copy of this document:
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Audit Compliance Report
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Audit Compliance Report
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Audit Compliance Report
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Audit Compliance Report
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Click the link to download word file copy of this document:
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Audit Compliance Report
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Audit Compliance Report
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Audit Compliance Report
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Audit Compliance Report
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Key Parameter of the Below Page:
Audit Compliance Report
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Click the link to download word file copy of this document:
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Audit Compliance Report
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Audit Compliance Report
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Key Parameter of the Below Page:
Audit Compliance Report
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Click the link to download word file copy of this document:
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Key Parameter of the Below Page:
Audit Compliance Report
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Key Parameter of the Below Page:
Audit Compliance Report
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Click the link to download word file copy of this document:
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Click the link to download word file copy of this document:
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