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Chemistry, Manufacturing and Controls (CMC) is critical to attaining a successful registration filing and is an integral part of any pharmaceutical product application to the US Food and Drug Administration (FDA). CMC applies to the entire product development life cycle, as it begins during drug candidate selection and continues through post-approval and beyond.

The basics of Chemistry, Manufacturing and Controls (CMC)

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 must be tailored to the specific platform and delivery system of the drug (e.g., injectable, controlled release, inhalant, topical, solid dose, oral, etc.), as it is not “one-size-fits-all” or a list of tests that must be performed on every product.

Chemistry, Manufacturing and Controls applies to both the drug product and the facility in which the product is being manufactured:

Drug product

• The manufacturing process;
• Quality control release testing, and
• Specifications and stability of the product.

Manufacturing facility

• Design;
• Qualification;
• Operation, and
• Maintenance.

Consequences of CMC regulatory non-compliance

A critical aspect of CMC regulatory compliance is ensuring all CMC practices comply with current FDA guidance and code of federal regulations, as regulatory requirements and expectations are continually evolving. For example, if an FDA-approved finished drug product does not meet the manufacturing, packing, or stability parameters detailed in the submission provided to the Agency, the marketing authorization is deemed non-compliant with manufacturing procedures. Consequences for non-compliance to CMC regulatory requirements can include:

• Addressing gaps in data under the scrutiny of regulatory agencies;
• Withdrawal of marketing authorization;
• Suspension of product distribution, and/or
• Consent decree and fines.

Considerations for partnering with a CDMO for CMC

Small and virtual pharma

Early drug development is increasingly carried out by smaller organizations, rather than large, vertically integrated biopharma companies, and many of these small organizations partner with contract development and manufacturing organizations (CDMOs) for the Chemistry, Manufacturing and Controls aspects of regulatory applications. For smaller pharmaceutical organizations, as a drug candidate moves into cGMP and CMC phases, due to limited internal resources, the experience and expertise of a CDMO is both necessary and critical to obtaining regulatory approval.

Benefits of a CMC-centric CDMO partnership

Drug product submission applicants benefit greatly from the resources made available by a CDMO partner. CDMOs have the depth of regulatory and scientific knowledge needed 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 Element’s CMC experts

Enrich the quality and efficiency of your regulatory submission and meet Agency expectations with the support and guidance of Element’s CMC experts. With decades of CMC experience and a depth of knowledge and understanding of current FDA guidance and regulatory requirements, our leaders and scientists can help you to determine the best CMC strategy for your drug product. Our commitment to applying our scientific expertise is evident in our proven track record of providing comprehensive and complete CMC support for successful regulatory applications.