*Manik Dandvate, K. N. Tarkase and N. S. Pawar


Annual Product Quality Review (APQR) is an evaluation which is prepared according to the cGMP requirements of different regulatory authorities like USFDA (United states of America), European Union, MHRA(United kingdom) ANVISA (brazil) Etc. A good manufacturing practise guarantees that goods are consistently manufactured and monitored in accordance with quality standards. Annual Product Quality Reviews not only are required by GMP it also required for robust quality improvement for manufacturing the pharmaceutical product day by day. Annual product review is an evaluation conducted annually to assess the quality of each drug product with a view to verify the consistency of predefined process and to check the suitability of present requirements and to draw attention to any trends in order to decide whether it is necessary to alter any manufacturing procedures or requirements for drug products. It is a written report is required for every drug product, based on data collected at least yearly basis. It is designed to reduce the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product or in process test. It is universally accepted by the industry and contents must specify a list of manufactured batches, release data and reviews of CAPA, change control, OOS (Out of specification), OOT(Out of trend), BMR(Batch manufacturing record), BPR (Batch packaging data), deviations, market complaints, recall and returned goods, stability data. This article gives brief overview of regulatory requirements for Annual Product Quality Review of pharmaceutical product. It primarily focuses on the paperwork needed to prepare the annual product quality review. Thus, the article is based on the legal requirements or standards to produce pharmaceutical drugs in accordance with specifications and to preserve their quality.

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