Do isolated synthetic intermediates intended for use in the next process step need to be quarantined and released by the quality unit? 1.37K viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K September 21, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted September 21, 2020 0 Comments Spread the loveNo. As Section 6.7 tells you, Quality can delegate to the production unit the responsibility and authority for release of intermediates. So unless the intermediate is being sold, it does not have to be released by the quality unit according to Q7A. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login