Objective of APQR (Annual Product Quality Review) in Pharma


Following the objective of the APQR (Annual Product Quality Review).

-To Verify and evaluate the the consistency of the manufacturing process ; if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process.
-To review and evaluate the quality of the product and trend of the quality of the product
-To review the trend of the yield , in process checks and Analytical results of the intermediate stage
-To review the quality of the raw material and packing ,material
-To review the details related to the quality management system (change control, deviation ,out of specification, Rejection, recall, market complaints ).
-Review of the CAPA its effectiveness.
-To review the on going stability study.
-Identify the risk related to the process, quality of the product.
-If any abnormality found in trend data based on the data process can be improved.
-It is designed to minimize the product defects and also the risks associated with the manufacturing of the pharmaceutical product.
-Proactively minimize risks to patients, operations, and supply chain through early detection and endtoend product oversight

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