Is microbiological control in the environmental clean room necessary if the room is not used for injectable grade products? 996 viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K January 5, 2021 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted January 5, 2021 0 Comments Spread the loveSection 4.2 states that if microbiological control is necessary, your facilities should be designed to minimize the possibility of microbiological contamination. Sterile APIs are outside the scope of Q7A. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login