For submission of the PAI, FDA needs one batch produced or one validation batch, can a demo batch be acceptable for that if a validation protocol already exists for future commercial campaigns? 1.10K viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K October 1, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Sam Smith11.38K Posted October 1, 2020 0 Comments Spread the loveYes, as long as the future batches will be produced by the same process as the demo batch. Spread the love Login
