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. Like current good manufacturing practices (cGMP, or GMP), CMC reviews have regulatory requirements established by the US 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.
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 their effectiveness and guaranteeing their compliance with the relevant regulations. Where CMC and GMP differ most is in their scope. While CMC information is completely product-specific, GMP is a quality framework that overarches a manufacturer’s whole operation. Thus CMC practices and GMP may have overlapping aspects, but they are not the same.
CMC describes a range of activities that ensure quality is built-in to any new drug product. Numerous critical elements are involved in assuring that both manufacturing practices and product specifications are defined with absolute batch-to-batch consistency and safety in mind. It stems from the identification of lead compounds and the verification of raw material quality 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.
On the other hand, GMP describes a framework of reasonable quality assurances that not only underlie 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.
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 your product and where you are 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 direct FDA-liaising.
At Design Space InPharmatics, we provide leading CMC regulatory solutions combined with implementation of GMP systems. If you would like to learn more, contact a member of the team today.