FDA Guidance for Industry: Q11 Development and Manufacture of Drug Substances
Title:
FDA Guidance for Industry: Q11 Development and Manufacture of Drug
Substances
Origin/Publisher:
ICH / FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM261078.pdf
Content:
This guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 – 3.2.S.2.6.