CTD Section 3.2.P.5.3 Report
Summary
Section Name:
Validation of Analytical Procedures
Section Code:
3.2.P.5.3
Module Number:
3
Description:
Provide any available validation or verification information for the analytical procedures used to test the drug product. This section may not be required for an original IND.
Submission Timing
Include in initial IND if requested, update in annual reports
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
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