ICH Guideline on Development and Manufacture of Chemical Entities and Biotechnological/Biological Drug Substances

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ICH has finalized Q11 Guideline on development and manufacture of chemical entities and biotechnological/biological drug substances, effective May 2012. The guideline describes approaches to developing and understanding the manufacturing process of the drug substance, and provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD) sections 3.2.S.2.2 – 3.2.S.2.6. There are differences between the draft and the final document in the areas of design space and critical quality attributes.

Read the guideline here.