ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

Title:
ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
Short Title:
ICH Q11

https://www.gmp-compliance.org/files/guidemgr/Q11_Step_4.pdf

Origin/Publisher:

Document Type:
ICH Guideline
Content:
This guideline describes approaches to developing and understanding the manufacturing process of the drug substance, and also provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD).

Go back