Chemistry, Manufacturing and Controls (CMC)

Chemistry, Manufacturing and Controls (CMC) refers to the processes and documentation involved in producing pharmaceutical products. It encompasses the chemical formulation of drugs, the manufacturing processes used to create them, and the quality control measures that ensure safety and efficacy. CMC ensures that medicines are consistently produced to the required standards, allowing regulatory agencies to evaluate their suitability for public use. It is a critical aspect in the development and approval of new drugs, ensuring that they are made correctly and are safe for patients.