Can you perform accelerated stability studies on an API to extend the retest date if running room temperature studies concurrently? And, the statement is made, “Drug product firms do this routinely, to place a two-year expiry date on the product.”

Going back to one of those slides, way back in the first session, if Q7A does not prohibit
something, it’s probably okay to do it. Q7A does not prohibit running accelerated studies. It does
not recommend, or it does not require, it is not an expectation that you’d run them. And, if the
person feels that running those accelerated helps meet the requirement to provide, in terms of
retest dates that should be based on evaluation of data derived from stability studies, and that’s
part of their stability study, to help them get the data on which they could make a sound
judgment, then it may be appropriate to do it. There’s nothing in Q7A that would prohibit it or
would say that the data generated from that was not scientifically sound and could contribute to
the decision.
But just remember that Part 211 says that any tentative expiration date assigned to a drug
product based on accelerated data must always be verified by shelf-life studies. While this applies
for drug products, it may be applicable to APIs as well.