Current regulations require written documentation for all existing products in the company; this documentation is known as the Annual Product Quality Review in Pharma (or ‘APQR‘).
Product Quality Review (PQR) is the historical analysis of a product’s quality based on all regulatory documents applicable in the national pharma field, internationally recognized criteria, and each company’s internal guidelines.
Product Quality Reviews are conducted to:
verify the consistency of existing process parameters,
the accuracy of current specifications of both raw materials and finished products,
and to uncover specific information to identify product and process improvements.