The concepts in pharmaceutical approval are vastly different than clinical care which is the basis for US Core. The Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC) IG will continue to create profiles that will characterize the manufacture of drugs. There will be a continued conflict with the US Core and more exceptions to come. Would it be possible to change the realm for this IG to C1 Unclassified Realm or create a Non-clinical Realm?