Change of process, stability study requirment

We have changing process of filtration, ANF to filter press. Is it required to kept 3 batches for stability at all conditions. Else we can kept only at accelerated condition (40/75). Since the process does not directly impact on product.

I think if you have a reasonable RA report that there is no effect on your product, it is ok. However, I think if you conduct it at accelerated condition, maybe there is some effect on that. And also, your policy is aslo important to support your tacts

Thank you.