A SHORT COMMUNICATION ON PREPARATION AND APPLICATION OF ANNUAL PRODUCT QUALITY REVIEW IN BIOPHARMACEUTICAL INDUSTRIES

  • Seetha Ram Kotra Department of Biotechnology Acharya Nagarjuna University Guntur
  • Divya Jyothi G Department of Microbiology, Acharya Nagarjuna University, Guntur – 522510. 3Department of Biotechnology, Anna University, Chennai – 638401
  • Nithiyaa J S Department of Biotechnology, Anna University, Chennai – 638401
  • Satish Babu K Department of Biotechnology, Vignan University, Guntur – 522213.
  • Atulya Kumar Nanda Department of Biotechnology, Fakir Mohan University, Odisha – 756020.
  • Kvc Chakrapani Department of Chemistry, JRNRVU, Rajasthan – 313001.

Abstract

In 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.

Author Biographies

Seetha Ram Kotra, Department of Biotechnology Acharya Nagarjuna University Guntur
Department of Biotechnology Acharya Nagarjuna University Guntur
Divya Jyothi G, Department of Microbiology, Acharya Nagarjuna University, Guntur – 522510. 3Department of Biotechnology, Anna University, Chennai – 638401
Department of Microbiology, Acharya Nagarjuna University, Guntur – 522510. 3Department of Biotechnology, Anna University, Chennai – 638401
Nithiyaa J S, Department of Biotechnology, Anna University, Chennai – 638401
Department of Biotechnology, Anna University, Chennai – 638401
Satish Babu K, Department of Biotechnology, Vignan University, Guntur – 522213.

Department of Biotechnology, Vignan University, Guntur – 522213. 

Atulya Kumar Nanda, Department of Biotechnology, Fakir Mohan University, Odisha – 756020.

Department of Biotechnology, Fakir Mohan University, Odisha – 756020. 

Kvc Chakrapani, Department of Chemistry, JRNRVU, Rajasthan – 313001.
Department of Chemistry, JRNRVU, Rajasthan – 313001.

References

. Pharmaceutical Inspection co-operation scheme, “Guide to Good Manufacturing Practice for Medicinal Products PE 00910†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

Published
2019-01-05
How to Cite
Kotra, S. R., G, D. J., S, N. J., K, S. B., Nanda, A. K., & Chakrapani, K. (2019). A SHORT COMMUNICATION ON PREPARATION AND APPLICATION OF ANNUAL PRODUCT QUALITY REVIEW IN BIOPHARMACEUTICAL INDUSTRIES. Mintage Journal of Pharmaceutical and Medical Sciences (ISSN: 2320-3315), 6-8. Retrieved from http://mjpms.in/index.php/mjpms/article/view/416

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