A SHORT COMMUNICATION ON PREPARATION AND APPLICATION OF ANNUAL PRODUCT QUALITY REVIEW IN BIOPHARMACEUTICAL INDUSTRIES
AbstractIn regulatory scope of biopharmaceutical industries, annual product quality review (APQR) is a structured and exhaustive summary of a licensed human pharmaceutical or biopharmaceutical product, which provide insights about the consistency and robustness of the process. APQR / PQR facilitates to highlight the trends of process parameters of product/s or for process improvements for all commercial products. APQR is essential for good manufacturing practices and also important for improvement to fill gaps in manufacturing system for compliance. It is a comprehensive document prepared annually for each licensed medicinal product based on the data generated for the financial year for respective product/s with a window time of four months. The main philosophy behind the need of APQR is risk reduction, productivity, compliance & verification of validation status. This article provides ideal regulatory requirements for APQR preparation, with focus on data analysis requirements to analyse the batch data to draw meaningful insights on the process for improvement. As of now, this is the first review on annual product quality review as per regulatory requirements in view of current good manufacturing practices.
. Pharmaceutical Inspection co-operation scheme, â€œGuide to Good Manufacturing Practice for Medicinal Products PE 00910â€ Part I and II. [Accessed on 16 Jan 2015].
. Commission of the European Communities. The Rules Governing Medicinal Products in the EC., Vol. IV, (Last accessed on 17/1/2015)
. Good Manufacturing Practice for Medicinal Products. Luxembourg: Office for Official Publications of the EC, 1992. ISBN 92-826-3180-X. (Last accessed on 17/1/2015)
. Food and Drug Administration, Department of Health and Human Services. 21 CFR 210, 211.Washington: Office of the Federal Register National Archives and Records Administration, 1997.
. European Commission, Enterprise and Industry, Pharmaceuticals, Documents, New GMP Provisions for Product Quality Review, website announcement, 2005
Copyright (c) 2019 Mintage Journal of Pharmaceutical and Medical Sciences
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.