CMC (Chemistry, Manufacturing, and Controls) occurs during all stages of the drug development cycle and ensures quality and consistency during the manufacturing of the pharmaceutical product.
Chemistry: This involves the detailed description of the chemical structure of the drug, the chemical properties, and the composition of the formulation.
Manufacturing: This covers the methods used to produce the drug, including the scale of production, the process flow, and any quality control measures to ensure consistency.
Controls: This pertains to the tests, standards, and procedures in place to ensure that both the raw materials and the final product meet regulatory requirements. This also includes stability studies to determine the shelf life of the drug.
CMC is crucial because it connects the scientific details of drug development with the practical aspects of large-scale production, serving as a crucial link between the two. Because CMC applies to all stages of pharmaceutical development and focuses on creating consistency in drug product stability, release, and manufacturing.
Useful links to learn more about CMC are:
- Quality guidelines of the EMA gives on overview of scientific guidelines on the quality of human medicine.
- Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.
- The European Medicines Agency’s scientific guidelines on the manufacture of medicinal products help medicine developers prepare marketing authorisation applications for human medicines.
- Data on the quality, production and control of the medicinal product being researched needs to be included in the Investigational Medicinal Product Dossier (IMPD) for clinical trial application and in module 3 of the Common Technical Document (CTD).
- FDA information sheet: Chemistry, Manufacturing, and Controls: Requirements for Early Clinical Development (link)
- The general text and specific monographs of pharmacopoeias (compendium of texts on the qualitative and quantitative composition of medicines, and on the tests to be carried out on medicines, on the raw materials used in the production of medicines and on the intermediates of synthesis), such as the European Pharmacopoeia Online