Hello all !! good morning.
I have a subject to be discussed regarding stability studies of API.
Is it required to initiate stability study for an API after milling as per customer requirement. Already stability initiated for un-milled as per IH specification(Filed).
If yes or no why?
Can we consider transferring site stability data for assigning retest period by showing equipment equivalency.? How ever receiving site will initiate the stability study.
Hoping positive discussions.
Tattukolla Satya Babu