If a new product haven’t stability, how can we assign retest and expriy date to them??
And a product Mfg presses same for Usp, Ep & ip… But we have 5 yr stability data in Usp… Shall we plan to use the same 5yr retest to ep & ip, is it’s acceptable??
No, you have to initiate the stability study for the required product and based upon the results you have to assign the retest or expiry.
Aim of Stability study is to ensure the manufacturing process/ systems/ equipments were having the capabilities to produce the product and their results were as per acceptance criteria…