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Annual Product Quality Review in Pharmaceutical Industry

Annual Product Quality Review (APQR) is a regulatory requirement for pharmaceutical companies. It helps drug manufacturers to summarize and evaluate their various processes and parameters.

Annual product quality reviews of all registered pharmaceutical products, including export ­only products, should be conducted to highlight any overall trends (not necessarily visible with other quality systems) and to identify product/process improvements by verifying and identifying:

  • the consistency of the existing process(es);
  • trends in product data;
  • the appropriateness of current specifications for starting materials, intermediates and finished products; to verify compliance of the registered particulars of pharmaceutical products (Marketing Authorisation);
  • deficiencies not detected by routine testing, monitoring or performance metrics; and
  • identify opportunities for product and process improvements.

A Summary on the Requirements of PQR/APR

There is a requirement to perform an Annual Product Review (APR) for US medicinal products and Product Quality Review (PQR) for medicinal products for EU and other countries. This applies to all medicinal products manufactured, packaged, or tested during a pre-established 12-month time period.

  • The PQR/APR is compiled by the manufacturer of the product, and or the site responsible for
  • RELEASING the medicinal product to market on behalf of the NDA/MA holder.
  • The NDA/MA Holder should retain a physical copy of the APR/PQR.
  • Non-pharmaceutical products are not subject to annual review requirements.
  • If no batches are produced for the review period, a memo from the manufacturer confirming this fact should be requested and approved by the QP/Quality Unit. An APR/PQR is still required to capture the other required areas/activities, such as change controls and stability.

Annual Product Quality Review Report

A PQR report should be prepared for every scheduled review using a controlled report template to ensure a standardised documentation approach.  The report should include the following:
  • product name(s);
  • batch size(s) and presentation(s);
  • review date;
  • references to source data;
  • comparison of the review from previous PQRs;
  • date that the next review is required;
  • groupings and scientific justification;
  • identification of issues or trends;
  • summary of findings, conclusions and recommendations;
  • proposed actions; and
  • names and signatures (with date) of the persons responsible for preparing, reviewing and approving the report.

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