Change Control Management: An Overview

Abstract

Change control is a basic element of the quality management system of a pharmaceutical company, that focuses on controlling change to provide a quality product by preventing non - compliance. Changes may occur at any time during the product life cycle, leading to changes in the manufacturing process, the number of materials, and the manufacturing location. All of these changes are post-approved changes. These changes can be controlled and not eliminated, through proper assessment and action plans. The change control committee consisting of the head of quality assurance, manufacturing, sales and other members of relevant disciplines, inspect the proposed changes that may alter the validated and qualified state of facilities, equipment or process. The proposed change will likely have an impact on the quality of production or Good Manufacturing Practice as there are done to be in line with the International Standard Organization requirements. These approved changes should not impact the quality, safety and potency of medicinal product. If ignored, it makes the patient life - critical which may even lead to death. This present review provides an overview of the industry’s Change Control change management protocol in Quality Management System in a company. The major objective is to identify, evaluate, measure, provide action and final authorization to ensure that the changes should not affect the product strength, integrity, purity, quality, or safety. There are many aspects of view on the change control management that take place in the pharmaceutical industry, where we can gain knowledge on concepts of change control. This article also delivers a flow of change management process starting from the request on change by an initiator to the closure of change with appropriate remedial action and follow up assigned by Quality Unit and other responsible authorities.