Technical Operations

Chemistry, Manufacturing, and Controls (CMC) is a regulatory term used to describe the documentation and processes related to the manufacturing and quality control of pharmaceutical drug products, drug substances, and devices. While Quality Assurance functions to oversee these activities, Technical Operations functions to execute the manufacturing, testing, packaging/labeling, distribution, and stability testing on drug products, drug substances, and devices. CMC begins with assessing a potential drug’s safety and formulation/manufacturability and continues through process and analytical development, scale-up, and commercialization. CMC requirements differ between each stage in a product’s lifecycle.  Understanding each stage is essential to assure consistency and quality.

Each phase of the product lifecycle introduces specific CMC requirements to ensure product safety, efficacy, and compliance with regulatory standards. During the Research stage, the focus is on initial characterization and formulation development, while Early Phase Clinical emphasizes process scalability and basic quality controls. As products move into Late Phase Clinical and Registration, more rigorous validation, documentation, and stability testing are required. Commercialization demands robust manufacturing processes, comprehensive quality systems, and ongoing regulatory compliance to maintain consistent product quality.