eCTD Module 3

eCTD Module 3

Module 3 Quality

The name of the folder for module 3 should be m3.

Module 32S drug substance
If the product contains multiple drug substances, then documentation for each substance should be provided in its own m32s section. If a drug substance is manufactured at multiple sites or by multiple different manufacturing companies, documentation can be provided in multiple m32s sections.
 
Module 32p drug product

Each dosage form covered by an eCTD application should be described in its own m32p section. If an application describes multiple strengths of any one dosage form, then documentation that covers all strengths can be provided in a single m32p section, or alternatively each strength can be covered by its own strength-specific documents in multiple strength-specific CTD sections.

22. März 2012Permalink