ICH Q11 Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) - Scientific guideline
Table of contents
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
-
List item
ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) (PDF/408.32 KB)
Adopted
First published: 11/02/2013
Last updated: 11/02/2013
Legal effective date: 01/11/2012
EMA/CHMP/ICH/425213/2011 -
List item
Draft ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) (PDF/538.36 KB)
Draft
First published: 16/06/2011
Last updated: 25/05/2012
Legal effective date: 01/11/2012
Consultation dates: 01/05/2011 to 16/09/2011
EMA/CHMP/ICH/425213/2011 -
List item
Questions and answers - ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities) (PDF/460.79 KB)
Adopted
First published: 06/10/2017
Last updated: 06/10/2017
Legal effective date: 28/02/2018
EMA/CHMP/ICH/809509/2016 -
List item
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)' (PDF/272.89 KB)
First published: 23/03/2017
Last updated: 23/03/2017
EMA/71927/2017 -
List item
Draft questions and answers - ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities) (PDF/351.73 KB)
Draft: consultation closed
First published: 15/12/2016
Last updated: 15/12/2016
Consultation dates: 15/12/2016 to 15/03/2017
EMA/CHMP/ICH/809509/2016