Pharmaceutical companies are required to submit a full Product Quality Review (PQR) or APQR in the U.S. and PQR in Europe to government health authorities annually, detailing key aspects of the manufacturing process for each drug they produce. APQR or PQR is a mandatory requirement that used to verify the consistency and appropriateness of an existing manufacturing process. It plays a critical role in identifying any trends in the process further leading to process or product improvements. It is an evaluation which is prepared according to the CGMP requirements of different regulatory authorities. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product the content.
PQR goes beyond the basic regulatory requirements and provides users with organized analytics for critical functions. In doing this, it certainly promotes a value of continuous Product Quality Review. Below are a few benefits: