Annual Product Quality Review

Abstract

Annual Product Quality Review (APQR) is an estimation prepared according to the Current Good Manufacturing Practice (CGMP) requirements of different regulatory authorities. A Good Manufacturing Practice (GMP) ensures that the products are constantly produced and controlled according to quality standards. APQR is not only required for GMP but also required for the quality improvement of the pharmaceutical product. APQR is an evaluation carried out annually to measure the standard of quality of each drug with an intention to verify the constancy of current process and to check the correctness 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 that is required for every drug, based on the data that was collected in the previous year. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the finished product. The APQR is globally accepted by the industry and the contents should 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 focusses 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.