Transition from Manual APQR to Automated APQR Whitepaper

Annual Product Quality Review, also termed as PQR & APR is performed every year by regulated industries. An annual affair of the pharmaceutical companies, it is not only a regulatory requirement, but also an essential tool to evaluate the company’s existing processes. It takes away almost 3-4 months of quality personnel’s time.Yet, every manufactured product is evaluated based on the current specifications and records.

Why APQR?
For APQR, a vast amount of data is collected, analyzed, and meaningful information is extracted. The main reason behind it is to re-validate processes that don’t efficiently ensure the quality of the product. It also aims at identifying issues at a budding stage, nibbing them with right decisions, and moving ahead with world class products ensuring safety. In case any deviation is detected, the pharmaceutical companies can stop further damage by halting the batch release. By performing APQR, a company can evaluate its quality policies, production processes, and product performance in the market.

Human safety being the foremost one. Based on the level of deviation, organizations face different consequences. To avoid 483s, organizations need to adhere to regulatory guidelines

Regulatory bodies such as USFDA, MHRA, TGA, Health Canada, EMEA, and others emphasize on quality products. They plan and update various regulatory guidelines such as GxP, ISO, and others from time to time. With progressive tools in use, the guidelines evolve along with the manufacturing processes.