During inprocess check if any parameter found out of acceptance limit,what should be the action plan?

If that parameter has a validated range that needs to be within limit to ensure quality od the product (i.e. Critical Process Parameter, CPP), then a process deviation has to be issued, since that batch will not be manufactured under validated conditions; thus, will not be manufactured in compliance with cGMP.

If that parameter is not a Critical Process Parameter (CPP), but instead, it is a Key Process Parameter (KPP), then it will depend on how the management of key process parameters is handled in your facility; but generally those are intended to be adjusted as needed by the process to put it back in statistical control. Just always make sure those changes are documented in compliance with good documentation practices (GDP) and be part of the batch record.


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