Q11 (Step 4, 1 May 2012)
Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
ICHICH guidelineOtherDevices and medicinesHigh confidenceLast verified October 4, 2026
Describes approaches to developing and understanding the manufacturing process of the drug substance, and what information goes in module 3 of the Common Technical Document for the process sections.
Recognition by market
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|
| United States | Adopted | - | Vol. 77, No. 224, p. 69634-5 | Effective November 1, 2012 |
| European Union | Adopted | - | CHMP/ICH/425213/2011 | Effective November 1, 2012 |
|
Related standards: Q5A(R2), Q5B, Q5D, Q5E, Q8(R2), Q12, Q13, ISO/IEC 17050-1, AS/NZS 3551, UN Manual of Tests and Criteria, section 38.3. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
