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Annual product quality review is prepared in pharmaceuticals to review the conformity of products annually with respect to their quality including deviations, change control and market complaints. It is used as an effective product quality improvement tool.
Annual product reviews verify the consistency of existing manufacturing processes. It also helps in determining product quality and process defects. It determines the flaws and potential improvements in methods and processes. Yield trends, analytical results, product manufacturing parameters are also highlighted.
It reviews the quality of raw materials and packing materials used for the product. The trends in these materials also dictate the quality and supplier of the material. In-process and finished product results are reviewed to determine product quality consistency.
The final product quantity is reviewed by the yield trend of each batch. Assists in determining process defects during production of certain products outside of specification. Batch failure is also included in the APQR to determine product batch rejection. Stability study and its trends help to determine defects related to product stability.
APQR helps determine the need for re-validation of the process and the impact of any improvements previously made. 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. The FDA uses the term “Annual Product Review” (APR) while the term “Product Quality Review” (PQR) is used in the EU-GMP guidelines.
In accordance with 21 CFR 211.180 (e), all finished products should be reviewed annually for quality standards to determine the need for changes in drug product specifications or manufacturing. Market complaints and product recalls should be reviewed annually. See the guidelines
PIC/S APQR guidelines call for conducting and documenting periodic reviews of pharmaceutical products annually. Starting and packing materials, complex in-process controls, failed batches and their investigation, deviations and changes performed in the process and analytical methods should be included in the annual product review.
As with other guidelines, ICH Q7 states that quality product reviews should be conducted annually and the reasons for corrective action should be documented and completed in a timely manner. See the guidelines
Preparation of APQR is not mandatory in WHO GMP regulations but all other regulatory bodies have notified preparation of APQR.
