Avoiding The Pitfalls Of PQR

The Product Quality Review (PQR) is a crucial tool for pharmaceutical and biopharmaceutical manufacturers to demonstrate both product quality and regulatory compliance. The FDA recommends conducting PQRs at least annually, but the frequency of PQRs can vary due to the type of product, number of batches produced annually, and associated risk based on the history of the process. However, performing a PQR annually is generally accepted as best practice.

Despite being routine, producing a PQR can be a complex and labor-intensive process, often riddled with inefficiencies and potential risks to data integrity—from data collection to analysis, interpretation, and reporting. Explore the fundamentals of PQRs, common challenges manufacturers face in achieving PQR objectives, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR" by utilizing a digital Continued Process Verification (CPV) system, driven by a proactive and intentional focus on product quality and continuous improvement.