We had an FDA auditor objecting to a remilling of an API because the remilling was not included in the registration as an option. Based on the information provided here, I would understand that this is an acceptable reprocess. 1.33K viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K September 30, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted September 30, 2020 0 Comments Spread the loveIt is an acceptable reprocess under Q7A. However, if the are other regulatory issues, you should consult your regulatory agency. Spread the love Login