Chemistry, manufacturing, and control (CMC) information reinforces the connection between the quality of a candidate drug used in clinical studies and the end product marketed to consumers. It effectively outlines critical quality attributes across the full life cycle of drug products, from clinical development to commercial scale production. Current manufacturing practices such as cGMP or GMP have regulatory requirements established by the U.S. Food and Drug Administration (FDA). But where the goals of these two pharmaceutical control strategies are closely aligned, they differ significantly in approach and regulation.
CMC vs. GMP: What’s the Difference?
The ultimate goal of both CMC and GMP is to ensure drug products consistently meet stringent, pre-determined quality standards. They ensure the safety and efficacy of drug products by demonstrating effectiveness and guaranteeing compliance with the relevant regulations. Where CMC and GMP differ most is in their scope. While CMC information is product-specific, GMP is a quality framework that overarches a manufacturer’s whole operation. Thus, CMC practices and GMP may have overlapping aspects, but are ultimately not the same.
What is CMC?
CMC describes a range of activities that ensure quality is built in to any new drug product. Numerous critical elements are involved to assure both manufacturing practices and product specifications are defined with batch-to-batch consistency and safety in mind. This stems from the identification of lead compounds and verifying the quality of raw materials before use. Manufacturers must establish critical quality attributes (CQA) and in turn determine the essential process parameters (CPP) underlying desired quality. This meticulous attention to detail must carry through every subsequent stage in the drug pipeline, up to and including labeling the product correctly.
What is GMP?
On the other hand, GMP describes a framework of reasonable quality assurances that not only underlies product development but also record keeping, equipment maintenance, process validation, and so on. Traceability is a vital part of GMP compliance. The idea is that issues with product batches should be traced back to a cause somewhere in the unit operation, which helps identify other affected batches. However, CMC and GMP are not so different that they can be easily siloed into product quality versus process quality. There is an overlapping and often complementary relationship between the two compliance frameworks.
How to Synchronize CMC & GMP
Given the product-oriented nature of CMC reviews, it is implausible to outline a one-size-fits-all approach to synchronizing a CMC strategy with GMP. However, developing a robust understanding of the product and where you company is in the pipeline in tandem with a realistic grasp of your financial situation are central to this initiative. Outsourcing critical CMC and GMP services is often a cost-effective and reliable method of accelerating and optimizing your drug life cycle.
CMC consulting services, often described as CMC regulatory consulting, provide valuable support for regulatory planning and product development. Given the end-to-end nature of CMC information, CMC services are phase-appropriate, providing essential solutions such as fast-tracked designations and liasing with the FDA.
Design Space InPharmatics provides leading CMC regulatory solutions combined with implementation of GMP systems. Contact a member of the team today to learn more .