By Daniel Carpenito
Everyone in the pharmaceutical manufacturing industry understands or has at least heard of current Good Manufacturing Practices (cGMP). The requirements of the cGMPs are prescribed in Title 21 of the Code of Federal Regulations parts 210 and 211 (better known as 21 CFR part 210 and 211). But there is a unique situation in which the requirements of 21 CFR 211 in the manufacture of a drug are exempt. That is for the manufacture of Phase 1 investigational drugs.
So, how did we get here?