1. Context of Observation
During the WHO GMP inspection of AABBCC Pharmaceutical Plant, the inspection team observed that records for certain Critical Process Parameters (CPPs) were missing or incomplete in the approved Batch Manufacturing Records (BMRs) and associated manufacturing documents.
The missing records included process parameters applicable to manufacturing operations such as:
- Mixing/Blending Time
- Granulation Endpoint
- Binder Addition Time
- Drying Temperature
- Drying Time
- Moisture Content
- Milling Speed
- Compression Speed
- Tablet Compression Force
- Tablet Weight Adjustment
- Coating Pan Speed
- Inlet Air Temperature
- Exhaust Air Temperature
- Spray Rate
- Product Temperature
- Relative Humidity
- Differential Pressure
- Environmental Monitoring Readings (where applicable)
Although manufacturing activities were performed, documentation providing objective evidence that the CPPs were monitored and recorded during processing was either incomplete or unavailable for certain batches.
The observation represents a significant deficiency in:
- Good Documentation Practices (GDP)
- Data Integrity (ALCOA+)
- Batch Record Documentation
- GMP Compliance
- Process Traceability
- Pharmaceutical Quality System
Immediately after the inspection, Quality Assurance initiated a comprehensive investigation to determine:
- Extent of the issue
- Root cause
- Product impact
- Data integrity impact
- Regulatory impact
- Corrective and Preventive Actions (CAPA)
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Click the link to download the word file copy of following documents:
https://pharmaguidehub.com/product/audit-compliance-report-for-missing-critical-process-parameter-records/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Click the link to download the word file copy of following documents:
https://pharmaguidehub.com/product/audit-compliance-report-for-missing-critical-process-parameter-records/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Click the link to download the word file copy of following documents:
https://pharmaguidehub.com/product/audit-compliance-report-for-missing-critical-process-parameter-records/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Click the link to download the word file copy of following documents:
https://pharmaguidehub.com/product/audit-compliance-report-for-missing-critical-process-parameter-records/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR MISSING CRITICAL PROCESS PARAMETER RECORDS
Find below pages for complete report
Click the link to download the word file copy of following documents:
https://pharmaguidehub.com/product/audit-compliance-report-for-missing-critical-process-parameter-records/
