4. Module 3 Quality

Module 3:

  • presents the chemistry, manufacturing, and controls reports for the product.
  • full details of what should be included in Module 3 are provided in the ICH M4Q guideline.
  • sections on both active substance and medicinal product are included.
  • main headings:
    • 3.1 Table of contents of Module 3
    • 3.2 Body of data
    • 3.2S Active Substance
    • 3.2P+ Medicinal Product
    • 3.3 Literature references used in Module 3