is it mandatory to submit accelerated stability study on 3 batches for an old molecule ( age is more than 60 years)… as per Plant’s SOP, this molecule is well established and only annul long term stability is being performed… Accelerated stability study on 2 batches is only available for this molecule.
How can i justify to the health authority from the destination market for the non-availability of accelerated stability data on a 3rd batch ?
thank you in advance