Chemistry, manufacturing & controls refers to a specific collection of information that must be supplied to FDA in preparation for a drug-related application submitted in the Common Technical Document (CTD) format. It is an important part of the documentation included with applications for the manufacture of drug substances or drug products.
Two applicable guidance documents on CMC for human and veterinary products are here and here.
The term CMC is also used in PMA submissions to describe the section which contains detailed information about product manufacture and testing.
