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CMC Documentation

CMC Documentation

Author: protheragen wu

CMC Documentation

CMC stands for Chemistry, Manufacturing and Controls. The process in which drugs are evaluated with regard to their specific qualifications is called CMC documentation. It defines not only the manufacturing process itself but also the quality control release testing, specifications and stability of the product together with the manufacturing facility and all of its support utilities, including their design, qualification, operation and maintenance. All submitted regulatory documents require CMC data, such as Investigational New Drug Application (IND), Chemical and Technical Assessment (CTA), Marketing Authorisation Applications (MAA), New Drug Application (NDA), and Annual report. Sufficient detail must be provided so that the agency reviewers can understand and evaluate the process. European agencies in particular require a significant amount of information on raw materials of animal origin and on their use in the process, as well as in the preparation of master seeds or cell banks.

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