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Pharmacopeial Method Qualification Options
Posted: Tue May 25, 2021 11:02 am
by Mouleyre
If a Drug Product didn't have a USP Monograph but one did exist in the EP, would the FDA accept an EP Method in a submission as long as it was appropriately qualified?
Re: Pharmacopeial Method Qualification Options
Posted: Tue May 25, 2021 1:26 pm
by Consumer Products Guy
If I was still working, I'd sure push my boss and QA to accept that.
Many FDA regulations are too much of a gray area for my liking.
Re: Pharmacopeial Method Qualification Options
Posted: Thu Jun 17, 2021 6:34 am
by epsilon
Latest Usp editions have the trend to remove various things, I recently found out that they removed an API and also it's ref std. So I changed to BP or EP or at least if there is any relevant iso method
