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 of AABBCC pharmaceutical manufacturing facility, the following observation was received:
“Change control system not properly implemented.”
Although an approved SOP for Change Control management was available within the Pharmaceutical Quality System (PQS), it was observed that the implementation of the change control system was inadequate and not consistently followed across departments.
The inspection team observed the following deficiencies:
- Changes were implemented without formal change control initiation.
- Impact assessments were incomplete or inadequately documented.
- Risk assessment was not consistently performed before implementation of changes.
- Effectiveness verification after change implementation was inadequate.
- Temporary changes were not appropriately tracked and reviewed.
- Cross-functional review and approval process was weak.
- Some changes affecting GMP systems were implemented before QA approval.
This observation indicates weakness in the control, evaluation, approval, implementation, and monitoring of changes impacting product quality, systems, and compliance.
2. Root Cause Analysis (Detailed)
A detailed investigation was conducted using the 6M (Ishikawa) methodology.
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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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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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:
https://pharmaguidehub.com/product/audit-compliance-report-change-control-system-not-properly-implemented/
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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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:
https://pharmaguidehub.com/product/audit-compliance-report-change-control-system-not-properly-implemented/
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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Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/audit-compliance-report-change-control-system-not-properly-implemented/
Key Parameter of the Below Page:
Audit Compliance Report
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Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/audit-compliance-report-change-control-system-not-properly-implemented/
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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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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Key Parameter of the Below Page:
Audit Compliance Report
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Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/audit-compliance-report-change-control-system-not-properly-implemented/
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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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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Key Parameter of the Below Page:
Audit Compliance Report
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Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/audit-compliance-report-change-control-system-not-properly-implemented/
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/audit-compliance-report-change-control-system-not-properly-implemented/
