Process Revalidation
Please describe your process in detail.
Administrator ■
Process Validation
We have validated a process of Cefuroxime axetil tablets, for 3 batches, using same raw material source.
As per the critreria of revalidation if any change in source of raw material, is it required to do the blend uniformity like intial validation. ■
Process Revalidation
We are revalidating the process, because of change active raw material source.
Is it required to do the process validation three consecutive batches and blend uniformity analysis (Before lubrication and After lubrication).
Please suggest ■