• Formulating

  Stability Regulations - US

  Posted by LisaS on May 21, 2020 at 1:10 pm

  Hi all, I am reading the ICH Q1A (R2), and the way that I am reading this [bc of the scope] is that it applies specifically to NDA drug products, no necessarily monographed drug products (MDPs), but can be used where there are gaps in regulation for MDPs. It looks like 21CFR211.137 & 166 as well as the FDA’s technical guide to stability for drug products are more geared toward MDPs specifically. Or am I totally incorrect and have to follow the ICH for both MDP and NDAs? Thank you for your help!

  LisaS replied 4 years, 6 months ago 1 Member · 0 Replies

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