If FDA is inspecting your firm, one of the first places they will investigate is your change control program. The critical questions that will be asked are: Does your firm’s change management procedure adequately specify impact and timelines? Does your change control categorize the types of changes as well as provide a detailed justification of why a change is needed?
In a recent FDA inspection of an OTC contract manufacturer of liquid gel formulations, we see that change control procedures are problematic if they fail to categorize the types of changes with detailed justification as well as address timeframes and an impact assessment. In our February 15 issue number 1154, we highlight this observation:
The firm change control procedure SOP …, “Change Control System” does not categorize their change controls or provide detailed guidance on the implementation and completion of a change control. The procedures also do not include an impact assessment or timeline for completion of the change. Change control numbers … and … for stability expiration … and numbers … and … for … APl … in all the OTC products do not provide a detailed justification, assessment, and implementation of these changes. There is also no timeframe established or confirmation of completion for each change.
As can often be seen, the rest of this company’s 483 report all connected back to this one observation. It had implications for the raw material testing procedures, the finished product stability, cleaning methods, and identity testing.
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