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

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Current effective version

Adopted guideline


Reference numberCHMP/ICH/425213/2011
Effective from01/11/2012
KeywordsDrug substance, synthetic, biological, development, manufacture, dossier requirements, starting materials
DescriptionThis 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).

Document history

First version

Current version

Adopted guideline

Draft guideline

In operation: 01/11/2011-present

Published: 01/05/2011

Questions and answers

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


Adopted questions and answers


Overview of comments


Draft questions and answers

In operation: 28/02/2018-present


Published: 23/03/2017



Published: 15/12/2016

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