Greetings:
I think it’s obvious that at a minimum it is ‘best practice’ to include a change log or history of change (whatever you want to call it) section typically at the end of a GMP document like a test method or SOP. My question is where, if anywhere, is it required by the CFR? I believe I found a secton (6.11 to be specific) of the ICH Q7 document that could be interpreted to require a history of change section. I’d appreciate any feedback on this topic.
Regards,
Socrates
See 820.40(b): “Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.”
Generally, the history section covers many of these elements. Could you do it otherwise? Sure, but I would say that this is the de-facto standard.