A Review on Change Management System in Pharmaceutical Industry

  • Nishi Ugvekar STUDENT
  • Krishnanand Kamath K
  • E.V.S. Subramanyam
  • A.R Shabaraya

Abstract

Change control system provides a consistent and well-structured approach towards managing deviations and changes.  Changes are unavoidable in a pharmaceutical manufacturing operation. Change management system is a systemic approach adopted by the pharmaceutical industries wherein qualified representatives of appropriate disciplines and personnel review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The change management system includes the implementation plan, installation, verification and the closure of the change control. Changes are classified as critical, major and minor. After the implementation of proposed change, an evaluation of the change should be undertaken to confirm the change objectives are fulfilled and achieved and to make sure that there are no detectable impact on final product quality.

Keywords: Change control, Implementation, Quality Management System, SUPAC, Quality assurance

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How to Cite
Ugvekar, N., K. K. K, E. Subramanyam, and A. Shabaraya. “A Review on Change Management System in Pharmaceutical Industry”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 3, Sept. 2021, pp. 37-41, doi:10.22270/ijdra.v9i3.482.