Dear all Hi
I`m a new member and feeling happy to be a part of this group.
Can anybody tell me:
i) Shall we validate a reprocessing method where rejected batches are reprocessed by repetition of last purification step.
ii)Also the specifications of input rejected batches is not fixed.
Thanks
Sanjeev Mahajan
[quote=sanjeevma]Dear all Hi
I`m a new member and feeling happy to be a part of this group.
Can anybody tell me:
i) Shall we validate a reprocessing method where rejected batches are reprocessed by repetition of last purification step.
ii)Also the specifications of input rejected batches is not fixed.
Thanks
Sanjeev Mahajan[/quote]
Well Sanjeev, Revalidation is done when there is a chnage in any of the critical process parameters, formulation, primary packaging components, raw material fabricators, major equipment or premises. Failure to meet product and process specifications in sequential batches would also require process re-validation. In case of failure to meet process specifications, optimization of the process and formulation is required. Mostly in case of solid dosage forms it is feasible to recover the rejected batch after some reprocessing but it depends wether the cause of rejection was an NC or it was a formulation problem.