Is there a limit to the number of times a given batch of API can be reprocessed? 1.06K viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K October 1, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted October 1, 2020 0 Comments Spread the loveThis is not specified in Q7A. If reprocessing happens often, then it may need to be placed into the filing itself. However, this is usually not a serious issue from a GMP perspective, since multiple reprocessing would normally increase purity. Spread the love Login
