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The finally agreed Production Rationale is a formal record of the assessment and categorisation, e.g. critical and non-critical, of all product quality impacting parameters, which provides the justification for every subsequent process control measure, be it by facility, utility or equipment qualification, automation validation, calibration, in-process monitoring, standard operating procedure (SOP) or training.
Any subsequent proposed alteration to the production process, for whatever reason, should result in this ‘living’ document being revisited and revised accordingly.
If you would like some guidance or assistance in the generation of a Production Rationale, please give us a call. There is no other company out there with more experience.
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