CTD Module 3 is the section of the common technical document (CTD) regulatory submissions format that contains all the required quality information and data corresponding to the registration of a pharmaceutical product. The CTD Module 3, also referred to as ICH Module 3, includes requirements for presenting manufacturing, characterization, drug substance controls, stability characteristics, descriptions and compositions of pharmaceuticals, and other essential information. The M4Q (Monitoring for Quality) guidance provided by ICH (International Council on Harmonisation) is a best-practice standard for completing Module 3 documentation.
In preparing your regulatory submissions, keep in mind that the overarching goal of following the eCTD is to make your documents reviewer-friendly. Module 1 is specific to every ICH region, which means it’s technically not part of the eCTD because it’s not common to all regions. Modules 2 through 5 contain the CTD and applies to all regions.
Specifically, eCTD Module 3 contains the pharmaceutical quality documentation. It describes the format and organization of the chemical, pharmaceutical, and biological data relevant to the application. eCTD Module 3 includes the table of contents, body of data, and literature references. The ICH website has more information about eCTD Module 3 and other modules.
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The CTD Module 3 format outlines the requisite section names and numbers necessary for organizing your drug product’s quality-related content. It’s best to follow an electronic checklist that encompasses all Module 3 requirements and have the list and associated documentation viewed, reviewed and collaborated on by appropriate employees as well as partners and suppliers. These approved personnel will be reviewing documentation from various locations, so the system should preferably be web-based or updated regularly. Quality documentation and data should also be “attached” to the appropriate drug product as most companies are working on getting multiple drugs registered at the same time.
Learn more about MasterControl’s Regulatory Excellence solutions. To streamline both submissions and regulatory management processes, as well as Module 3 documentation, please contact one of our representatives.