An Annual Product Quality Review must be conducted for each commercial product. The purpose of this annual review is to verify the consistency of the process, to assess trends, to determine the need for changes in specification, production, manufacturing and/or control procedures and to evaluate the need for revalidation. Annual Product Quality Reviews (APQRs) are important for communication between manufacturing, quality and regulatory Affairs, to enable quality improvement processes. Content and management of Annual Product Reviews must be established according to this directive.

Requirement of APQR:

• In USA – “Annual Product Review“
• In Europe, the EU GMP Guideline uses the term “Product Quality Review”.
• Requirement or expectations are almost same.
• APQR should be conducted for all commercial products.
• APQR should confirm the State of Control.

Regular quality reviews of APIs should be conducted with the objective of verifying the consistency of the process. Such reviews should normally be conducted and documented annually and should include at least:

• A review of critical in-process control and critical API test results;
• A review of all batches that failed to meet established specification (s);
• A review of all critical deviations or non-conformances and related investigations;
• A review of any changes carried out to the processes or analytical methods;
• A review of results of the stability monitoring program;
• A review of all quality-related returns, complaints and recalls; and
• A review of adequacy of corrective actions.