SEETHA RAM K, DIVYA JYOTHI G, NITHIYAA JS, SATISH BABU K, ATULYA KUMAR NANDA, KVC CHAKRAPANI
In regulatory scope of biopharmaceutical industries, annual product quality review (APQR) is a structured and exhaustive summary of a licensed human pharmaceutical or biopharmaceutical product, which provides insights about the consistency and robustness of the process. APQR / PQR facilitate to highlight the trends of process parameters of product/s or for process improvements for all commercial products. APQR is essential for good manufacturing practices and also important for improvement to fill gaps in manufacturing system for compliance. It is a comprehensive document prepared annually for each licensed medicinal product based on the data generated for a financial year for respective product/s with a window time of four months. The main philosophy behind the need of APQR is risk reduction, productivity, compliance & verification of validation status. This article provides ideal regulatory requirements for APQR preparation, with focus on data analysis requirements to analyze the batch data to draw meaningful insights on the process for improvement. As of now, this is the first review on annual product quality review as per regulatory requirements in view of current good manufacturing practices.