RE: RE: RE: Purpose of API stability study
Contribution from srilatha lingabathula written on 4/14/2012 at 18:19
Original contribution: RE: RE: Purpose of API stability study written by Arun David on 4/12/2012 at 07:48)
Even though your product has a determined shelf life, you have to do stability studies on every batch until the expiry date for consumer safety. When you made shelf life, you may not have taken all the criteria or circumstances in account which you don't know and in the process you may have changed your raw material supplier or processes. If anything might have changed that may affect the stability of product which you can detect in the stability studies. This is primarily for customer safety according to my knowledge.
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