ICH moving towards Q11

The International Conference on Harmonization’s (ICH) Expert Working Groups (EWGs) and Steering Committee met during the week of November 7, 2010, in Fukuoka, Japan. Quality Expert Working Groups meeting that week included those for the ICH Q4B guideline on the evaluation and recommendation of pharmacopoeial text for use in the ICH Regions, the Q3D guideline on metal impurities, the Q11 guideline on development and manufacture of drug substances (including chemical and biotechnological entities). The ICH Q8, Q9, Q10 Implementation Working Group also met, as did a new multidisciplinary expert working group comprised of safety and quality experts to discuss the ICH M7 guideline on the assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.