Do isolated synthetic intermediates intended for use in the next process step need to be quarantined and released by the quality unit? 961 viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K January 8, 2021 0 Comments 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted January 8, 2021 0 Comments No. 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. Register or Login