CTD Section 3.2.P.3.5 Report
Summary
Section Name:
Process Validation and/or Evaluation
Section Code:
3.2.P.3.5
Module Number:
3
Description:
This section should contain information on what methods are employed by the Quality Unit to prevent processing/manufacturing errors. It is not required for early stage manufacturing, and this section can contain a general discussion on how the Quality Unit will serve this function. Alternatively, the recommended information can be discussed in other sections and this section can be skipped.
Submission Timing
Required prior to initiation of Phase 3 manufacturing
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources