APQR:
Regular, periodic or rolling quality reviews of all pharmaceutical products, including products for export only, shall be conducted with the objective of verifying the consistency of the existing process and the appropriateness of current specifications for both starting materials and finished product, to highlight any trends and to identify product and process improvements.
Such reviews shall normally be conducted and documented annually, taking into account previous reviews, and shall include at least, -
(a) review of starting materials and packaging materials used for the product, especially those from new sources and in particular the review of supply chain traceability of active substances;
(b) a review of critical in-process controls, and finished product results;
(c) a review of all batches that failed to meet established specifications and their investigation;
(d) a review of all significant deviations or non-conformity, the related investigations and the effectiveness of resultant corrective and preventive actions taken;
(e) a review of all changes made to the processes or analytical methods;
(f) a review of dossier variations submitted, granted or refused;
(g) a review of the results of the stability monitoring programme and any adverse trends;
(h) a review of all quality related returns, complaints and recalls and the investigations performed at the time;
(i) a review of adequacy of any other previous corrective actions on product processes or equipment;
(j) post marketing commitments for new dossiers and variations to the dossiers;
(k) the qualification status of relevant equipment and utilities, e.g., heating, ventilation and air conditioning, water or compressed gases and a review of the results of monitoring the output of such equipment and utilities; and
(l) a review of technical agreements to ensure that they are up to date.
The manufacturer shall evaluate the results of the review and an assessment shall be made as to whether corrective and preventive actions or any revalidation shall be undertaken, under the product quality system. Corrective and preventive actions shall be completed in a timely and effective manner, according to documented procedures. There shall be procedures for the on-going management and review of these actions, and the effectiveness of these procedures shall be verified during self-inspection. Quality reviews may be grouped by product type e.g., solid dosage forms, liquid dosage forms, or sterile products, where scientifically justified. There shall be a technical agreement in place between the various parties that defines their respective responsibilities in producing the quality review. The authorized person responsible for final batch certification shall ensure that the quality review is performed in a timely manner and is accurate.
Guidelines:
Schedule M; Part-1, Section 2.3
GUIDANCE NOTES ON PRODUCT QUALITY REVIEW, HSA January 2007
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