Should all three batches be stored in final proposed packaging? 1.51K viewsOctober 10, 2022FDA 0 Sam Smith11.38K November 2, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted November 2, 2020 0 Comments Spread the loveYes. You should package all three batches in the container closure system proposed for marketing. ICH Q1A(R2) addresses this question (see section II, B, 4, Drug Product Container Closure System (2.2.4)). Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login
