CRED Managing Variations Effectively

Is a Variation Required? ● Look at ICH Q12 for “established conditions” - identify certain CTD components as the “registered details” requiring maintenance – For example, P.2 and P.3.5 are historical data and may not need updating ● Am I adding detail versus amending detail? E.g. – Introduction of additional IPC’s to be considered as in- house measurements – Addition of internal action limits to a specification ● Are the changes covered by other legislation? E.g. – Reprocessing for NCE’s is allowed under GMP regulations provided it only occurs on an infrequent basis (ICH Q7)