CMC documentation is a specific section within broader regulatory submissions such as a New Drug Application (NDA) in the U.S. or a Marketing Authorization Application (MAA) in Europe.
It provides a comprehensive outline of the entire production cycle for a pharmaceutical product, covering both the Active Pharmaceutical Ingredient (API) and the finished dosage form. This documentation includes crucial details on the chemical and physical properties of the drug substance and product, as well as the manufacturing process, analytical methods, and control strategies. It elaborates on synthesis protocols, stability data, purity metrics, quality control measures, and manufacturing processes, complete with validation and quality assurance protocols.
CMC documentation serves as a vital framework for ensuring regulatory compliance and product quality throughout the development and production lifecycle.