I have a question, in active pharmaceutical ingredient industry if i have a process validated to scale of 500 kg and we need to change the batch size to 800 kg in the same equipment, is necessary the revalidation of process? or if i demostrate that the process is equivalent in it´s physicals and chemicals chacaracteristic is not necessary the revalidation?
Thanks for you help.[/quote]
Typical changes that require revalidation include changes in a raw material or packaging material sources, changes in the process parameters, changes to equipment, including major repairs, change in batch size and changes to the premises. Because it can affect the process, so I suggest that process should go for revalidation. This suitation lie under te heading of revaldation after change.