CMC (Chemistry, Manufacturing and Controls)

CMC, or Chemistry, Manufacturing, and Controls, refers to the processes and regulations ensuring the quality and safety of pharmaceutical products. It involves three key aspects: the chemical composition of the drug, how it is made (including manufacturing processes), and the controls in place to maintain consistent quality. CMC ensures that medicines are produced reliably and meet regulatory standards before they reach patients. This is critical for both the efficacy of the drug and patient safety, as it addresses everything from ingredient sourcing to final product packaging.