Are formal stability studies required for an Intermediate that you are planning on holding? 1.15K viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K October 2, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted October 2, 2020 0 Comments Spread the loveQ7A does not expect formal stability studies or monitoring studies except for the finished API, except where the intermediate is to be transferred outside of the control of the manufacturer’s material management system. Spread the love Login