Chemistry, manufacturing and controls (CMC)

Chemistry, manufacturing and controls; also referred to as pharmaceutical quality/CMC.

The term covers the various procedures used to assess the physical and chemical characteristics of drug products, and to ensure their quality and consistency during manufacturing. CMC data are an important part of submissions to regulatory authorities.

Video definition by Stephen Robinson, Drugs for Neglected Diseases initiative (DNDi) (Switzerland).

Chemistry Manufacturing and Controls (CMC) Guidances for Industry (GFIs) (FDA, 2020)

Quality guidelines (EMA)