QUALITY MANAGEMENT SYSTEM IN CHANGE CONTROL AT INDUSTRY LEVEL: AN OVERVIEW

  • N. Vishal Gupta JSS College of Pharmacy, Mysuru
  • Lokesh M. S. JSS University

Abstract

Change is inevitable in a pharmaceutical manufacturing operation. Vendors change processes, sources, and specifications for raw materials, equipment requires repair, service, or replacement, manufacturing locations are changed, batch sizes are increased or decreased and advancements in technology are made that dictate changes to the operations. After issuing of Marketing Authorization and/or manufacturing, many changes occurs across the Product lifecycle, i.e. Scaling up of pilot batch into commercial batch and variation in manufacturing processes, excipients and manufacturing sites. All these changes are considered as post approval changes or variations. These variations need to be approved by the respective regulatory authorities of a country. If not, it puts the marketing authorization holder and/or license holder at risk. Proper management of changes is critical and proper change management reduces the risk of suspension of licenses and the warning letter from the regulatory authorities. The present review provides an industry perception on Change Control system and importance of the Quality Management System.

 

Keywords: Marketing Authorization, Post Approval Changes, Marketing Authorization Holder

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Author Biography

N. Vishal Gupta, JSS College of Pharmacy, Mysuru

Assistant Professor

Department of Pharmaceutics

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How to Cite
Gupta, N. V., and L. M. S. “QUALITY MANAGEMENT SYSTEM IN CHANGE CONTROL AT INDUSTRY LEVEL: AN OVERVIEW”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 7, no. 5, Apr. 2015, pp. 13-19, https://innovareacademics.in/journals/index.php/ijpps/article/view/4782.
Section
Review Article(s)