Process Revalidation

peyyeti.veeru
(not verified)
Posted in: , on 15. Jul. 2008 - 16:13

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

Author
(not verified)

Process Revalidation

Posted on 15. Jul. 2008 - 04:27

Please describe your process in detail.

Administrator

peyyeti.veeru
(not verified)

Process Validation

Posted on 16. Jul. 2008 - 01:45

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.