CTD Section 3.2.S.3.2 Report
Summary
Section Name:
Impurities
Section Code:
3.2.S.3.2
Module Number:
3
Description:
Describe test procedures to remove process- and product-related impurities, and set appropriate limits (these may be refined with additional manufacturing experience)
Submission Timing
Initial IND or IND amendments (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources