eCTD  Module 3

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, characterisation, 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.

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