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:

• 
  Statistical Process Control Notes pdf
• 
  In-Process Quality Control (IPQC) Notes
• 
  Complaints and Recalls in Pharmaceuticals
• 
  Change Control in Pharmaceutical Industry
• 
  Self Inspection
• 
  Line Clearance in Pharmaceuticals
• 
  Out of trend (OOT) Notes pdf