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

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Document details

Download document Draft ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities)
Reference number EMA/CHMP/ICH/425213/2011
Status adopted
First published 16/06/2011
Last updated 25/05/2012

Summary

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.