RA206 Chemistry Manufacturing and Control

CMC stands for Chemistry, Manufacturing, and Controls. The CMC section of a pharma application refers to detailed documentation of the pharmaceutical product’s chemistry, manufacturing processes, and quality control measures. The CMC section is an essential component of the application that must be submitted to regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), for approval to market and sell the drug.

The CMC section is a critical part of the drug development process, as it helps ensure that the drug is manufactured consistently, meets quality standards, and is safe and effective for patients.

This course is designed to highlight Chemistry, Manufacturing, and Controls (CMC) data as well as changes to approved NDAs.

The course addresses the information to be submitted for the drug substance to ensure continued substance and product quality. Other required information for submission is discussed.

Learning Points:

• Role of CMC in drug development
• eCTD CMC sections
• Submission requirements for:
• Identity, strength, quality, purity, and potency of a drug product
• Nomenclature, structure, and general drug substance properties
• Manufacture
• Characterization
• Control of drug substance
• Reference standards or materials
• Container closure system
• Stability
• Drug Master Files Considerations for CMC submissions