Draft:Annual Product Quality Review
Annual Product Quality Review (APQR) conducted in regulated industries, evaluates product quality standards and manufacturing processes comprehensively. It confirms adherence to quality attributes and specifications mandated by regulations, ensures process consistency, and assesses changes to prevent adverse effects on quality or compliance. APQR also identifies improvement opportunities, fostering continuous improvement and regulatory adherence within regulated industries.[1].
The implementation of Annual product quality review offers numerous benefits for pharmaceutical manufacturers, which includes improved product quality, regulatory compliance, proactive problem solving, continuous improvement and more.[2].
The Annual Product Quality Review (APQR) is a crucial regulatory requirement in industries that manufacture products subject to stringent quality standards and regulations. While it is primarily associated with the pharmaceutical industry, where it is mandated by regulatory authorities such as the US FDA and EU EMA, product quality review processes are also essential in other regulated sectors. Some industries where PQR or similar product quality review necessary includes: 1) pharmaceuticals 2) biotechnology 3) medical devices manufacturing 4) gene therapy 5) cosmetics manufacturing 6) food and beverages 7) vetenary manufacturing 8) chemical and agrochemical[3].[4].