Product Quality Review (PQR / APQR)
- ​Answer: The PQR demonstrates the consistency of the commercial manufacturing process and the appropriateness of specifications. It must encompass:
- ​Review of raw materials and packaging materials (especially from new suppliers).
- ​Statistical trend analysis of in-process tests and finished product release data (calculating C_p and C_{pk} capability indices).
- ​Evaluation of all out-of-specification (OOS) and out-of-trend (OOT) investigations.
- ​Review of all deviations, manufacturing incidents, and associated CAPA effectiveness.
- ​Review of all changes made to processes, analytical methods, or formulations.
- ​Trend review of ongoing/post-marketing stability data.
- ​Summary of customer complaints, product recalls, and pharmacovigilance reports.
- ​Re-qualification status of critical utilities (HVAC, Purified Water/WFI) and analytical instruments.
