The ICH Q11 Guideline on Development and Manufacture of Drug Substances was adopted in 2012. These Q&As published in 2018 provide additional clarification 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.

More information can be found on the ICH website at https://www.ich.org/products/guidelin....

ICH is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Visit our website at https://www.ich.org.