Annual Product Quality Review: As A Quality Enhancement Tool and Its Regulatory Perspective

Abstract

For process enhancement in pharmaceuticals various quality management tools are used which are being described in quality management system. According to regulatory guidance for improving the quality of the product as well as to reduce the frequency of the failure of the batch Quality management system and risk management approach should be combined with the current good manufacturing practice. Quality management tools include Quality by Design (QbD) approach, Process Analytical Tool (PAT), Annual Product Quality Review (APQR), Risk management, Corrective and Preventive Action (CAPA). Out of such tools these project describes about the role of annual product review in the industry for maintain the quality of the product annually. Annual product quality review (APQR) is prepared in pharmaceutical to review consistency of the products annually regarding their quality including the deviations, manufacturing controls and market complaints. It has also been mandatory and has been described by US-FDA 21 CFR 210-211 i.e. cGMP of industries manufacturing medicinal products for humans and animals. Annual review consist of the quality attributes and data of starting material, in-process results, and finished product of each and every batch manufactured during the entire year. It also consists review of the long term stability data, qualifications status of instruments, HVAC system, water system, and utilities. Process capability (Cpk) value is being calculated which gives the idea about that the process is capable or not. Review of batch failure, deviations, and market complaints is also added in the annual review. Change control and Corrective and preventive actions are taken in contrary for above errors. Errors are being identified from the trends of control charts which are included in the annual product review batch wise. Out of specifications (OOS) observed in the chart is being recognized as error. Investigation of Error and Corrective acions taken should be documented in the review. In order to achieve continuous improvement one must also attempt to implement the annual product review to match and surpass the need of the customer.