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Annual Product Review (APR)

The term APR most commonly heard in the pharma field but the people working in other departments not have much idea on this why because typically this can be done by Quality Assurance team. Before going to explore the information about APR we should know the definition. Definition of Annual Product Review (APR): Annual product review is an Evaluation conducted Annually to access the quality standard of each product and also to verify the consistency of each drug manufacturing process. Why APR is required in drug manufacturing units? I must say to determine the changes needed in drug process specifications or control procedures. This APR is used to determine the trend in order to improve the controlled procedures leads to revalidation. Retention Period in QA: Product Expiry + 1 Year = 6 Year Retention Period This Annual Product Review and filing mostly annoying due to deep dive into the data review process but by developing automation methods