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Annual Product Quality Review (APQR/APR/PQR) in Quality Improvements

Requirement of Annual Product Quality Review (APQR) in pharmaceutical manufacturing and guidelines of different regulatory agencies on product quality review.
Annual Product Quality Review is prepared in pharmaceutical to review the consistency of the products annually regarding their quality including the
deviations, change controls and market complaints. It is used as an effective product quality improvement tool.

Annual Product Review verifies the consistency of the existing manufacturing process. It also helps to determine the quality and process defects of
the products. It determines the defects and possible improvements to the method and process. The trend of the yield, analytical results,
manufacturing parameters of the products are also highlighted.

It reviews the quality of raw material and packing material used for the product. The trend of these materials indicates the quality of the material and
the supplier also. In-process and the finished product results are reviewed to determine the consistency of the product quality.

The quantity of the final product is reviewed by the trending the yield of every batch. Out of specification helps to determine the process defects
during the production of the specific product. Failure of the batch is also included in APQR to determine the batch rejection of the product. Stability
study and its trend help to determine the defects regarding the product stability.

APQR helps to determine the need for re-validation of the process and effect of any improvement made previously. Corrective and preventive actions
and their impact on product quality are also reviewed and determined.

Annual Product Quality Review is a mandatory requirement of Good Manufacturing Practice. FDA uses the term “Annual Product Review” (APR)
while “Product Quality Review” (PQR) term is used in EU-GMP guidelines.

According to 21 CFR 211.180 (e) all finished products should review annually for the quality standards to determine the need for the change in
specification or manufacturing of drug product. Market complaints and product recalls should also be reviewed annually. view guideline

PIC/S APQR guidelines state to conduct and document periodic review of the pharmaceutical products annually. Starting and packing material,
critical in-process controls, failed batch and their investigation, deviations and changes carried out in the process and analytical procedure should be
included in Annual Product Review.

Like other guidelines, ICH Q7 to states that Quality Product Review should be conducted annually and the reason for the corrective action should be
documented and completed in time. view guideline

APQR preparation is not mandatory in WHO GMP regulations but all other regulatory agencies have given notification to prepare the APQR.
Also see: Preparation of Annual Product Review

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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