CMC
Chemistry, Manufacturing, and Controls
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
CMC is the body of information in a marketing application describing how a drug substance and drug product are manufactured, controlled, and characterized — composition, manufacturing process, in-process and release testing, specifications, container closure, and stability. It is submitted as Module 3 of the CTD and is the technical foundation reviewers rely on to assess product quality.
CMC data must demonstrate that the manufacturing process is controlled and reproducible, that the analytical methods used to test the product are validated and suitable for their purpose, and that the specifications set are justified by process capability and clinical exposure — not simply set to whatever the process currently achieves.
CMC information is not static once an application is approved: manufacturing process changes, site changes, and specification changes after approval are governed by post-approval change classification and, where applicable, a PACMP, and significant CMC changes can require FDA review and approval before implementation even for an already-marketed product.
- —Covers manufacturing process, controls, specifications, and stability — submitted as CTD Module 3
- —The technical foundation reviewers use to assess product quality in an application
- —Specifications must be justified by process capability and clinical exposure, not just current output
- —Post-approval CMC changes are governed by change classification and, where used, a PACMP
FD&C Act §505; 21 CFR 314.50(d)(1); ICH M4Q (Quality) — CTD Module 3
Frequently asked questions
What does CMC stand for?
CMC stands for Chemistry, Manufacturing, and Controls.
What is CMC?
CMC is the body of information in a marketing application describing how a drug substance and drug product are manufactured, controlled, and characterized — composition, manufacturing process, in-process and release testing, specifications, container closure, and stability. It is submitted as Module 3 of the CTD and is the technical foundation reviewers rely on to assess product quality.
Which regulations cover CMC?
FD&C Act §505; 21 CFR 314.50(d)(1); ICH M4Q (Quality) — CTD Module 3