Hazard Analysis and Critical Control Points as a Quality Risk Management Tool in the Pharmaceutical Industry: A Systematic Review

Hazard Analysis and Critical Control Points as a QRM tool

  • , Priya School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Dehradun-248001, Uttarakhand, India
  • Meenu Chaudhary School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Dehradun-248001, Uttarakhand, India


For several years, quality risk management (QRM) has been such an integral component of healthcare as well as pharmaceutical product manufacturing. Effectual QRM can help companies make better informed and smarter choices, and furnish regulators with more prominent confirmation of an organization's capacity to manage possible dangers. In the pharmaceutical sector, the Hazard Analysis and Critical Control Points (HACCP), a QRM tool is comparatively a new approach. It is a globally perceived management system that gives rules to the pharmaceutical and food industries. HACCP approach emphasizes the hazards, with the overarching goal of ensuring that drug products are safe to use because the production of drug products is prone to health together with safety concerns. The HACCP system offers guidance to a considerable extent for quality control, by detecting, assessing, monitoring, and validating the crucial procedures and operations in the manufacturing of pharmaceutical products. The presented review article provides HACCP as a risk assessment tool, which could be applied to various parts of drug quality so that it might promote and assist the adoption of quality practices by pharmaceutical industries with the objective of improving HACCP efficiency together with company performance.

Keywords:  HACCP, Hazards, QRM, Quality

Keywords: HACCP, Hazards, QRM, Quality


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Author Biographies

, Priya, School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Dehradun-248001, Uttarakhand, India

School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Dehradun-248001, Uttarakhand, India

Meenu Chaudhary, School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Dehradun-248001, Uttarakhand, India

School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Dehradun-248001, Uttarakhand, India


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Priya , Chaudhary M. Hazard Analysis and Critical Control Points as a Quality Risk Management Tool in the Pharmaceutical Industry: A Systematic Review. JDDT [Internet]. 15Oct.2021 [cited 1Dec.2021];11(5-S):167-75. Available from: http://www.jddtonline.info/index.php/jddt/article/view/5094