CTD Section 3.2.P.3.3 Report
Summary
Section Name:
Description of Manufacturing Process and Process Controls
Section Code:
3.2.P.3.3
Module Number:
3
Description:
Provide a flow diagram and narrative description of the complete drug product manufacturing process. Be sure to indicate/describe any in-process controls and intermediate tests.
Submission Timing
Initial IND, update as needed
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
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