Change Control Process In Pharmaceutical Industry : A Review

ABSTRACT

In the pharmaceutical industry, the Change Control process typically occurs when any change is proposed or required to a product, process, equipment, or system that could potentially affect the quality, safety, or compliance of the product. This paper includes a study to ensure the quality and safety of drugs and also avoids the future risks. This research investigates the root causes of incidents within the change control process in the pharmaceutical industry, analyzing the patterns and trends that lead to non-conformances and quality deviations. It ensures that any modifications, whether planned or unplanned, are thoroughly evaluated, authorized and executed in a controlled manner to minimize disruption, risk and inefficiencies. 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 . An effective change control process is critical in the pharmaceutical industry to ensure ongoing compliance with regulatory standards, maintain product quality, and safeguard patient safety, while minimizing potential risks associated with any changes to processes, materials, or systems.

Keywords: Change, Control, Quality, Safety, Process, Compliance, Product, Materials, Regulatory.