1. Context of Observation
During the WHO GMP inspection conducted at AABBCC Pharmaceutical Plant, the inspection team observed that several entries in the Batch Manufacturing Records (BMRs) had been corrected without following the approved Good Documentation Practices (GDP). The inspectors noted that certain corrections were made without appropriate justification, initials/signatures, date, time, or documented reason for correction. In some cases, correction fluid (white ink)/overwriting and multiple strike-throughs were observed, making the original entries unreadable.
According to WHO GMP requirements and ALCOA+ Data Integrity Principles, all manufacturing records must be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. Corrections to GMP records must preserve the original entry, include the corrected information, and be authenticated with the signature/initials, date, and justification.
Immediately after receipt of the observation, the Quality Assurance Department initiated a formal investigation to determine the extent of the issue, identify the root cause, assess product impact, evaluate data integrity risks, and implement suitable corrective and preventive actions.
The investigation team reviewed:
- Batch Manufacturing Records
- Batch Packaging Records
- In-Process Control Records
- Equipment Logbooks
- Cleaning Records
- Calibration Records
- QA Review Records
- Production Logbooks
- Good Documentation Practice SOP
- Training Records
- Internal Audit Reports
- Previous Deviations
- Change Controls
- CAPA Records
The investigation confirmed that unauthorized corrections were primarily associated with documentation practices rather than intentional falsification or manipulation of manufacturing data. A retrospective review demonstrated that manufacturing activities had been performed according to approved procedures and validated process parameters; however, documentation controls were not consistently implemented.
No evidence of product quality defects, contamination, mix-up, cross-contamination, or patient safety risk was identified.
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