Does ICH Q7 apply to manufacturing Steps for the addition of substance(s) to an API (e.g., to stabilise the API)? 1.53K viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K September 29, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted September 29, 2020 0 Comments Spread the loveWhen a mixture is classified in the regulatory filing as an API in a region or country in which it is used in a drug product, ICH Q7 should be applied to the manufacturing of these mixtures. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login
