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International Conference on Harmonisation Guidance document on Q11 is available - 20 Dec 2012

The ICH Q11 guidance entitled ‘‘Q11 Development and Manufacture of Drug Substances’’ is now available on the ICH website.  The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and also provides guidance on what information should be provided in the Common Technical Document (CTD) sections 3.2.S.2.2 – 3.2.S.2.6.  The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions. 

The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.  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 Systems (Q10) as they pertain to the development and manufacture of drug substance. 

A summary of changes includes the following: (1) Revisions to the introduction and process development sections to more strongly emphasize that purification processes play a significant role in drug substance manufacture, (2) revisions to the discussion of design space for chemical entities and biotechnological/ biological drug substances, and (3) revisions to the discussion of control strategy. In addition, some editorial changes were made to improve clarity.


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