Annual product quality review: Guidance for industry by regulatory perspective
Nagurla Sanjeevaiah, Sathishbabu Munaga
Annual Product Quality Review (APQR) is an evaluation which is prepared according to the CGMP requirements of different regulatory authorities. A Good Manufacturing Practice ensures that the products are consistently produced and controlled according to quality standards. Annual Product Quality Reviews not only are required by GMP but also required for robust quality improvement for manufacturing the pharmaceutical product. Annual product review is an evaluation conducted annually to assess the quality standard of each drug product with a view to verify the consistency of existing process and to check the appropriateness of current specifications and to highlight any trend in order to determine the need to change any drug product specifications or the manufacturing processes or control procedures. It is a written report is required for every drug product, based on data collected at least annually. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. It is universally accepted by the industry and contents must specify a list of manufactured batches, release data and reviews of deviations, complaints, recall and returned goods. This article gives brief overview of regulatory aspects and regulatory requirements for Annual Product Quality Review of pharmaceutical product. It mainly focuses on the documentation required for the preparation of Annual Product Quality Review. Thus the article is based on the regulatory requirements or standards to manufacture and maintain the quality of any pharmaceutical product.