Quality Product Review / Annual Product Review


This Standard Operating Procedure (SOP) describes the program necessary when conducting the Annual Product Review (APR) which must be performed for each commercial product. The purpose of this SOP is to provide clear guidance on how to perform an APR with the purpose to verify the consistency of the process, to assess trends, to determine the need for changes in specifications, production, manufacturing, and/or control procedures and to evaluate the need for revalidation.