1. Context of Observation
During the WHO GMP inspection of AABBCC Pharmaceutical Plant, the inspection team observed that certain in-process manufacturing data (e.g., tablet weight, hardness, thickness, friability, blend parameters, environmental observations, equipment operating parameters, and line clearance confirmations) were not recorded immediately at the time the activities were performed. Instead, entries were made after a time gap, resulting in delayed documentation.
The inspectors considered this observation a significant Good Documentation Practice (GDP) and Data Integrity (ALCOA+) deficiency because GMP requires that all manufacturing and quality-related activities be documented contemporaneously, providing an accurate and reliable history of the manufacturing process.
A detailed investigation was initiated by the Quality Assurance Department to determine the extent, root cause, product impact, and required corrective and preventive actions.
The investigation confirmed the following:
- Approved SOPs governing Good Documentation Practices (GDP), Batch Manufacturing Records (BMR), and In-Process Quality Control (IPQC) were available.
- Batch Manufacturing Records included designated fields for recording in-process observations.
- Operators performed the required in-process checks according to the manufacturing process.
- However, several records were completed after the activity rather than at the time it was performed.
- There was inadequate supervisory verification to detect delayed entries.
- No evidence of falsification or intentional manipulation of data was identified.
- Review of batch records, analytical results, and market complaints found no evidence of adverse impact on product quality, safety, efficacy, or traceability.
Therefore, the observation was concluded to be primarily a documentation and data integrity compliance deficiency, not a manufacturing process failure.
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
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Click the link to download the word file copy of following documents:
https://pharmaguidehub.com/product/audit-compliance-report-for-delayed-recording-of-in-process-data/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
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Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
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-delayed-recording-of-in-process-data/
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
Find below pages for complete report
Key Parameter of the Below Page:
AUDIT COMPLIANCE REPORT FOR DELAYED RECORDING OF IN-PROCESS DATA
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-delayed-recording-of-in-process-data/
