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During the WHO GMP inspection of a pharmaceutical plant, Name AABBCC, an observation was made that AUDIT COMPLIANCE REPORT OF PRODUCT QUALITY REVIEW (PQR) NOT PREPARED ANNUALLY. 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 at the AABBCC pharmaceutical manufacturing facility, the following observation was raised:
“Product Quality Review (PQR) not prepared annually.”
Although an approved SOP for Product Quality Review (PQR) was available within the Pharmaceutical Quality System (PQS), it was observed that annual product quality reviews were either not prepared within the defined timeline or not comprehensively compiled for all commercial products.
The inspection team identified the following deficiencies:
- Annual PQRs were overdue for multiple products.
- Trending of critical quality attributes and process parameters was incomplete.
- Data compilation from cross-functional departments was inconsistent.
- CAPA effectiveness from previous PQRs was not adequately reviewed.
- PQR timelines and responsibilities were not effectively monitored.
- No formal escalation system existed for delayed PQR preparation.
- Management review did not adequately monitor annual PQR compliance.
This observation indicates inadequate implementation and monitoring of the product quality review system despite procedural availability.
2. Root Cause Analysis (Detailed)
A detailed investigation was conducted using the 6M (Ishikawa) methodology.
2.1 Man (Personnel)
Key Parameter of the Below Page:
Audit Compliance Report
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https://pharmaguidehub.com/product/audit-compliance-report-of-product-quality-review-pqr-not-prepared-annually/
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-of-product-quality-review-pqr-not-prepared-annually/
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-of-product-quality-review-pqr-not-prepared-annually/
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-of-product-quality-review-pqr-not-prepared-annually/
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
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-of-product-quality-review-pqr-not-prepared-annually/
Key Parameter of the Below Page:
Audit Compliance Report
Find below pages for complete report
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-of-product-quality-review-pqr-not-prepared-annually/
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-of-product-quality-review-pqr-not-prepared-annually/
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-of-product-quality-review-pqr-not-prepared-annually/
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-of-product-quality-review-pqr-not-prepared-annually/
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-of-product-quality-review-pqr-not-prepared-annually/
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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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-of-product-quality-review-pqr-not-prepared-annually/
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-of-product-quality-review-pqr-not-prepared-annually/
Click the link to download word file copy of this document:
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