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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 4
First page : ( 1987) Last page : ( 1990)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00357.1

Change Control in Pharmaceutical Quality Management System

Aravindan N*, Seetharaman, Kamaraj Raju

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur – 603203, Kanchipuram, Tamil Nadu, India

*Corresponding Author E-mail: aravindan1306@gmail.com

Online published on 30 April, 2020.

Abstract

Change management system is a Some Licensed members of relevant disciplines inspect the proposed changes that alter the status of facilities, equipment or process and The Change control management is focus on change to prevent unplanned impact in pharma industry. Ensures that the changes should not affect the product quality or safety. The goal of the CC is a inhibit of control request. There are three stages of change control process. The first step of the company is to follow Good Manufacturing Practices (GMP). Firms must store the details of manufacturing, quality control, materials required and several other things required in this procedure. The change control committee is mainly working in different process its consists of head of quality assurance, manufacturing, sales and various other members. The major objective is to evaluate changes, determine the measure and provide final authorization and CCM is linked to multiple parts of an enterprise quality management system [EQMS].

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Keywords

Change control management, post approval change, marketing authorization.

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