Change Control Management Plan

[Shalini]

Change control management system refers to the controlled set of actions to ensure that a change does not negatively impact a product’s safety, quality or compliance. The control may be proactive or reactive, as a response to mitigate or eliminate the consequences of unplanned change, also known as deviation.

The important features of change control include:

A plan that identifies actions, inputs, outputs and control limits to determine successful achievement of the desired change
A record of required elements of plan review combined with supporting data
Essential regulatory approvals for the changed state before the product made under the change is released in the market
Enforcement of any new or updated Good Manufacturing Practice (GMP) documentation and appropriate staff training