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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 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 of the method and process. Trend of the yield, analytical results, manufacturing parameters of the products are also highlighted.

Requirements of Annual Product Quality ReviewIt reviews the quality of raw material and packing material used for the product. 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.

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 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 of 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 reviewed annually for the quality standards to determine the need of the change in specification or manufacturing of drug product. Market complaints and product recalls should also be reviewed annually. view guideline

PIC/S 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 too states that Quality Product Review should be conducted annually and 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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