(Section 11.2.) Should specs be set for non-critical Intermediates? 1.30K viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K October 2, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted October 2, 2020 0 Comments Spread the loveSection 11.2 clearly states, “For each batch of intermediate and API, appropriate laboratory tests should be conducted to determine conformance to specifications”. There is no distinction made between critical and non-critical. Spread the love Login