Get Points To Consider For The Submission Of Chemistry, Manufacturing, And Controls (CMC) Information

CMC (Chemistry, Manufacturing, and Controls) is one of the most important activities in drug product development. It occurs during all stages of the drug development cycle and ensures quality and consistency during the manufacturing of the pharmaceutical product.

Chemistry, Manufacturing and Controls (CMC) of a medicinal product is the body of information that 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, ...

The CMC essentials outlined in regulations and guidance(s) are designed to ensure that a drug is manufactured safely and consistently, from testing right through to commercialization and during the drug's post-approval lifecycle.

The value of CMC determines the efficiency of any biosurfactant; hence, this value is essential for comparison of biosurfactants. As illustrated by Cazals et al. [12], CMC value can be calculated by comparing it with surface tension.

CMC is a critical component that cannot be overlooked. It ensures that the drug product has a consistent formula so that the drug used in clinical trials is the same as what is made commercially available.

CMC upholds the connection between the drug used in clinical studies and the drug that is marketed commercially and made available to consumers. Chemistry, Manufacturing and Controls ensures patients have access to consistently efficacious, safe, and high-quality pharmaceutical and biopharmaceutical drug products.

CMC Submission means a dossier containing all chemistry, manufacturing and controls information filed by Supernus or its sub-licensees to the FDA and other Regulatory Authority to support a filing for Regulatory Approval, as set forth in 21 C.F.R. § 314.50.

CMC is an acronym for chemistry, manufacturing, and controls which are crucial activities when developing new pharmaceutical products. CMC involves defining manufacturing practices and product specifications that must be followed and met in order to ensure product safety and consistency between batches.