Chemistry, Manufacturing and Controls (CMC) is an integral part of any pharmaceutical product application to FDA. CMC is critical to attaining a successful registration filing. CMC is applicable to the entire product lifecycle – it starts during the drug candidate selection phase, and continues through post-approval and beyond.
Chemistry, Manufacturing and Controls: The Basics of CMC
CMC ensures that pharmaceutical and biopharmaceutical drug products are consistently effective, safe and high quality for consumers. It sustains a connection between the drug that is used in clinical studies and the commercial drug that is marketed and available to consumers. CMC isn’t a one-size-fits-all checklist or list of tests to be performed on every product, but is instead tailored to the platform and delivery system (e.g. injectable, controlled release, inhalant, topical, solid dose, oral, etc.).
Chemistry, Manufacturing and Controls applies to both the drug product and the facility in which the product is being manufactured:
- The manufacturing process
- Quality control release testing
- Specifications and stability of the product
Consequences of CMC Regulatory Non-Compliance
Regulatory requirements and expectations evolve, and as such, an important aspect of CMC regulatory compliance is to ensure that all CMC practices are in line with the current FDA guidance and code of federal regulations. For example, if a company has FDA approval for a drug product that isn’t manufactured, packed, tested or as stable as described in the submission provided to FDA, the marketing authorization is considered to be non-compliant with manufacturing procedures.
Consequences for non-compliance to CMC regulatory requirements can include:
- Having to address gaps in data under the scrutiny of regulatory agencies
- Withdrawal of marketing authorization
- Suspension of product distribution
- Consent decree and fines
Considerations for Partnering with a CDMO for CMC
Small & Virtual Pharma
As early drug development is increasingly carried out by smaller organizations, rather than large vertically-integrated biopharma companies, many of these small organizations partner with contract development and manufacturing organizations (CDMOs) for the Chemistry, Manufacturing and Controls aspects of regulatory applications. For these smaller pharma organizations, when a drug candidate moves into cGMP and CMC phases, internal resources are typically limited, and the experience and expertise of a CDMO is a needed resource.
Benefits of a CMC-Centric CDMO Partnership
Drug product submission applicants benefit from the resources made available by a CDMO partner. CDMOs have a depth of regulatory and scientific knowledge that is necessary to prepare an effective CMC section of a regulatory submission, including specifications and justification for components and products, analytical methods and method validations, stability data, and product and process design and/or validations.
Partnering with Avomeen’s CMC Experts
Avomeen’s CMC experts can enhance the quality and efficiency of your regulatory submission and meet Agency expectations. Our leaders and scientists have decades of CMC experience, and stay up-to-date with FDA guidance and regulatory requirements. With a proven track record of providing comprehensive and complete CMC support for successful regulatory applications, our commitment to applying our scientific expertise is evident. Get in touch with an expert to explore a partnership with Avomeen.
Our expert blogger is Neelam Varshney, Avomeen’s Sr. Technical Director, Pharmaceutical Sciences. Neelam’s diligence and intellect brings incredible value to Avomeen and to our clients. She has extensive experience in all CMC aspects of pharmaceutical products from preclinical testing and submission to IND/NDA modules to post-approval regulatory requirements. Neelam’s great wealth of regulatory knowledge of all CMC aspects include expertise in E&L for all product types, including drug-device combination products, and Avomeen’s clients benefit greatly from her insight and expertise in cleaning validation. To all of this, Neelam brings 22 years of pharmaceutical industry experience, primarily applying ICH and other regulatory guidance to build compliant products.