ICH Q11 Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) - Scientific guideline

This document describes approaches to developing and understanding the manufacturing process of the drug substance. It also provides guidance on what information should be provided in sections 3.2.S.2.2 – 3.2.S.2.6 (ICH M4Q). In addition, it provides further clarification on the principles and concepts described in ICH guidelines on pharmaceutical development (Q8), quality risk management (Q9) and pharmaceutical quality system (Q10).

Keywords: Drug substance, synthetic, biological, development, manufacture, dossier requirements, starting materials

This Q&A document is intended to provide additional clarification relating to the selection and justification of starting materials