Re: Process Validation Protocol (API) as per new FDA Guidelines
IOPQ in itself doesn't have any expiration dating!!!
Yet it can be revised/updated whenever there is significant change to spare parts/ modifications done to the equipment itself. (like you have added additional/advanced controls, or any part has been upgraded etc)
however, there is a re-qualification criteria defined as per your internal procedures. wherein you would take stock of the breakdowns, calibrations, preventive maintenance; changes, spare parts etc.,and where required actually perform the re-qualifications by running required tests.
in short, you would have addendums to IOPQ reports which are updated at pre set frequency.
Last edited by v9991; 30th October 2012 at 07:26 PM.