Change Control in Pharmaceutical Industry

Advertisement

Change Control in Pharmaceutical Industry

Change control within quality management systems and information technology systems is a process—either formal or informal—used to ensure that changes to a product or system are introduced in a controlled and coordinated manner.

It is an important element in any Quality Assurance system. Written procedures should be in place to describe the actions to be taken if a change is proposed to a product component, process equipment, process environment (or site), method of production or testing or any other change that may affect product quality or support system operation.

A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state.

Also Read:

Advertisement

Leave a Comment

Your email address will not be published.

Researchers discover new side effects of Aspirin and other NSAIDs D Pharmacy Exit Exam Date, Syllabus Update 2022 D. Pharmacy New Syllabus 2022 Update Genetic mapping reveals cancer growth What Distinguishes COVID-19, the Flu, and RSV?
%d bloggers like this: