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Change control - Coggle Diagram
Change control
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Key Features
Obtainment of necessary regulatory approvals for the changed state before the product made under the change is released to market.
A record of successful completion and review of the plan’s required elements together with supporting data.
Implementation of any new or updated Good Manufacturing Practice (GMP) documentation and appropriate staff training.
A formal plan that identifies actions, inputs, outputs and control limits, which would define successful achievement of the desired change.
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Definition
Annex 15 of the EU GMP Guidelines defines “change control” as:
“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.
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