What is the rationale to perform a stability study when there is no change in Resin, specification, process etc and is just a supplier change.
Every primary packaging material compose of polymer composition which includes resin & other colourant & other excipient based of IH formula. So every supplier have different formulation it’s obviously we need to perform stability study . If only supplier change ( mfg location of approved vendor) give us composition comparison along with process, equipment, other critical parameter comparison it can avoid stability study, how ever Three batch process validation need to evaluate as guidance tell us to do so.