Do the small scale batches need to be manufactured in accordance with all CGMP regulations, or is it acceptable to manufacture the small scale batches in a research setting? 1.57K viewsOctober 10, 2022FDA 0 Sam Smith11.38K November 2, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted November 2, 2020 0 Comments Spread the loveAll ANDA submission batches should be made following CGMP Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login