Does the out of spec procedure as required by Q7A also require OOE or out of expectation investigations? If so, what is the definition of OOE? 1.24K viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K September 29, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted September 29, 2020 0 Comments Spread the loveFirst of all, there is no requirement in Q7A. It is guidance, not a regulation. There is no guidance in Q7a with respect to OOE. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login
