Product quality review (PQR)

A periodic review, usually yearly and product by product, of manufacturing and quality data: batch results, deviations, changes, OOS results, stability data, complaints and returns. It confirms that the process remains consistent and the specifications remain appropriate, and it finds trends that single batches hide. Japan made product quality review an explicit article of the GMP Ministerial Ordinance (Article 11-3) in the 2021 revision. The EU counterpart is the product quality review in Chapter 1 of EU GMP; the US counterpart is the annual product review under 21 CFR 211.180(e). It is a review, not a pass or fail test, and its findings feed CAPA and change control.