Which module of the CTD contains Quality documentation?

The correct choice is based on the structure of the Common Technical Document (CTD), which is utilized for the submission of applications for pharmaceuticals. Module 3 specifically contains the Quality documentation. This module includes critical information regarding the pharmaceutical development, quality control, manufacturing processes, and stability information of the drug product. Quality documentation is essential for regulatory authorities to assess whether the product meets the required standards for safety and efficacy.

Modules 1 and 2 serve different purposes; Module 1 focuses on administrative and prescribing information applicable to various regions, while Module 2 summarizes the content included in the other modules. Module 4 is dedicated to nonclinical study reports. Understanding the specific content of each module is essential for effective regulatory submission and compliance.