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 end‐to‐end
product oversight
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