28 June 2011

The ICH Q11 Guideline on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) reached Step 2 of the ICH Process in May 2011 and now enters the consultation period (Step 3).

This new guidance 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.

The draft Guideline is available for download under the Quality Guideline page.

You are invited to provide comments on the draft Guideline by e-mailing the ICH Secretariat. More details under the Open Consultation page

Note that stakeholders from EU, US and Japan are encouraged to submit their comments to their respective Regulatory Authorities.