In the pharmaceutical industry, CMC stands for Chemistry, Manufacturing, and Controls. It is the process of ensuring that a drug product is safe, effective, and of high quality. CMC activities span the entire drug development lifecycle, from preclinical research to post-market surveillance.
In the context of regulatory affairs, CMC refers to the information that must be submitted to regulatory agencies to obtain approval for a drug product. This information includes detailed descriptions of the drug substance, the drug product, the manufacturing process, and the quality control procedures. Regulatory agencies use this information to assess the safety, efficacy, and quality of the drug product.
CMC regulatory affairs is a critical function in the pharmaceutical industry. It helps to ensure that safe, effective, and high-quality drug products are available to patients. The CMC certification assures each batch of drug, irrespective of its time and place of manufacture conforms to prescribed standards of strength, identity, quality and purity.
The CMC activities are complex due to the abundance of data and documentation required, and mismanagement of these processes with the regulatory bodies can result in delays to submissions, or non-compliance, and ultimately a delay to the launch of innovative medicines.