Chemistry Manufacturing and Controls or CMC
To maintain the safety, efficacy, and consistency of a pharmaceutical or biologic throughout time, it is necessary to specify the production procedures, product features, and product testing that will be used. CMC stands for "chemistry, manufacturing, and control," which describes these processes. After drug discovery, chemistry manufacturing and controls are involved in every step of the drug development process. Validation of analytical procedures for product monitoring occurs during preclinical drug development. Raw ingredients are selected and examined, physicochemical features of the product are identified, and stability testing can begin. When a drug reaches the clinical phase of development, more characterisation and validation of analytical methods are necessary. Scaling up production after clinical trials requires strict adherence to the original product's specifications to guarantee that the final product is effective and safe for human use. Following qu