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

Current effective versions

ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities)

AdoptedReference Number: EMA/CHMP/ICH/425213/2011Legal effective date: 01/11/2012

Questions and answers - ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities)

AdoptedReference Number: EMA/CHMP/ICH/809509/2016Legal effective date: 28/02/2018

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

Document history

ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities)

AdoptedReference Number: EMA/CHMP/ICH/425213/2011Legal effective date: 01/11/2012

Draft ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities)

DraftConsultation dates: 01/05/2011 to 16/09/2011Reference Number: EMA/CHMP/ICH/425213/2011Legal effective date: 01/11/2012Summary:

This guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 – 3.2.S.2.6. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance.

Questions and answers - ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities)

AdoptedReference Number: EMA/CHMP/ICH/809509/2016Legal effective date: 28/02/2018

Questions and answers - Overview of comments received on ‘Draft questions and answers - ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities)'

Reference Number: EMA/71927/2017Summary:

Overview of comments received by EMA on ‘ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities) - questions and answers’ (EMA/CHMP/ICH/809509/2016)

Draft questions and answers - ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities)

Draft: consultation closedConsultation dates: 15/12/2016 to 15/03/2017Reference Number: EMA/CHMP/ICH/809509/2016