What would be the impact if the SOP is distributed 1 day before it’s effective date either knowingly or unknowingly. And simultaneously during distribution to the concerned department , previous version of respective SOP is retrieved during distribution and master copy of the same is superseded next day i.e. the day on which it became effective actually?

If sop is without any annexure then no impact but if we are filling any format then the annexure of previous version sop has to be replaced with the new revised format on the day sop is effective.

It is expected that all required users ( minimum levels) shall be Trained on changes made and on NEW SOP mandates prior to EFFECTIVE DATE .Hence one shall estimate the actual time required for SOP training and evaluation prior to decide the Effective Date.

This area is strictly reviewed by FDA,MHRA and hence shall be strictly complied.

Hope it’s clear…KR Insights

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