ICH Q11 Questions and Answers on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), on the selection and justification of starting materials, reached Step 2b of the ICH process in November 2016 and is now in the consultation period. An associated training presentation has also been developed by the Expert Working Group.
Since the ICH Q11 guideline was finalised, worldwide experience with implementation of the recommendations on the development and manufacture of drug substances has led to requests for clarification relating to the selection and justification of starting materials. The Question and Answer (Q&A) document is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials and on the information that should be provided in marketing authorisation applications and/or Master Files. The focus of the Q&A document is on chemical entity drug substances.
Please click here to access the presentation.
The guideline and Q&A document can be found here.