What is CMC and why is it important?

What is CMC? CMC is an acronym for chemistry, manufacturing, and controls which are crucial activities when developing new pharmaceutical products. Beyond the processes themselves, CMC also refers to practices and specifications that must be followed and met in order to ensure product safety and consistency between batches.

What is the Americans with Disabilities Act (ADA)?

The Americans with Disabilities Act (ADA) is a federal civil rights law that prohibits discrimination against people with disabilities in everyday activities. The ADA prohibits discrimination on the basis of disability just as other civil rights laws prohibit discrimination on the basis of race, color, sex, national origin, age, and religion.

What is the role of CMC Regulatory Affairs and compliance?

CMC regulatory affairs and compliance is seen as a process of governance which ensures CMC practices are carried out in agreement with regulatory agencies requirements and expectations. Since such requirements and expectations change with time, a function of CMC regulatory compliance is to ensure that all CMC practices are updated accordingly.

Why do regulators need to know about CMC standards?

Regulatory authorities need to see detailed standards to ensure consistency of identity, safety, quality, stability, and strength between the product used for clinical trials and product batches produced for commercial purposes on an ongoing basis. Are CMC Practices Required?