Change Control and Validation

According to the Annex 15 of the EU Guide to Good Manufacturing Practice:

Change Control: A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated status of facilities, systems, equipment or processes. The intent is to determine the need for action that would ensure that the system is maintained in a validated state. (Annex 15, see chapter C.6.15.)

As we’ve discussed in class, some companies use change control when they’re bringing in a new piece of equipment/process where there has been no previous validation. Under the EU guidelines change control can only happen on validated systems. When starting a new process or bringing in new equipment you would normally look at risk assessment or impact analysis and some companies may call this change control. For the purposes of an exam if a question came up on explaining change control then I’m happy to accept either the EU definition alone or if you explain how your company uses change control I’ll accept this too once you also explain the EU’s definition. Any questions just drop me an email.

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