What is CMC?

What is CMC in pharma regulatory affairs?

Chemistry, Manufacturing, and Controls (CMC) represent a pivotal element in the pharmaceutical industry, encompassing the comprehensive set of information that outlines the production process of a medicinal product. This encompassing data includes intricate details about manufacturing procedures, quality control measures, release testing, product specifications, stability parameters, and the facilities involved in product manufacture. The adherence to regulatory guidelines within CMC is crucial to ensure that pharmaceutical companies meet the expectations and requirements set forth by regulatory agencies.

Responsibilities and the implications within the realm of CMC regulatory affairs carry significant weight. Marketing authorization holders (MAHs) are responsible for ensuring that the pharmaceutical product complies with the CMC information provided in the regulatory documentation. Failure to adhere to these standards can lead to penalties, revocation of marketing authorization, or the suspension of product distribution.

CMC data for market approval

There are many challenges associated with CMC in regulatory affairs which can hinder the process of market approval for pharmaceutical products. The magnitude of these challenges vary depending on the region. A common challenge that pharmaceutical companies face is ensuring the integrity of their data throughout manufacturing processes and maintaining detailed/comprehensive documentation so that they can provide agencies with accurate and reliable data to assess product safety and efficacy. For this, a robust data management system, methods to validate analytical methods, and procedures should be established in order to protect data integrity that is submitted regulatory authorities. Indeed, CMC documentation play an integral role in developing efficient regulatory approaches and strategies for products.

DDReg’s Capabilities

DDReg provides CMC advisory services that support its customers in preparing a robust regulatory strategy throughout product development stages:

Quality by Design (QbD) planning

Injectable packaging

Drug device combination products

API selection based on KSM

Exhibit batches

CMC document review for new product registrations and post-approval lifecycle management

Response to agency queries regarding CMC documentation

Authoring, compilation, and review of CMC section (relevant module 1 sections, module 2.3 and module 3)

Regulatory intelligence for CMC