The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

ICH Q11 Guideline: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers

Short Title:
Q11 Q&As

Document Type:
ICH document
This document provides clarification to improve harmonisation of the considerations for the selection and justification of starting materials for API syntheses.

Go back

GMP Conferences by Topics