During the WHO GMP inspection conducted at AABBCC Pharmaceutical Plant, the inspection team observed that the Vendor Qualification System was inadequate to ensure comprehensive evaluation, approval, monitoring, and periodic requalification of vendors supplying raw materials, packing materials, critical consumables, and services.
Although a Standard Operating Procedure (SOP) for Vendor Qualification was available and implemented, deficiencies were identified in the practical execution and documentation system. The inspection team observed gaps including:
- Incomplete vendor assessment records.
- Lack of documented risk-based vendor categorization.
- Absence of periodic vendor performance trend review.
- Inadequate documentation of vendor requalification activities.
- Limited quality agreements for certain approved vendors.
- Incomplete audit planning and vendor audit traceability.
- Insufficient justification for approval of some vendors without complete evaluation records.
The firm acknowledges the observation and has performed a detailed root cause investigation and risk assessment using Failure Mode and Effects Analysis (FMEA) methodology.
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