品質に関するトピックの動向ICH Q9(R1) 品質リスクマネジメント

抄録

This article describes progress of revision work of the ICH Q9 (Quality Risk Management: QRM) guideline and training materials. The first version of the ICH Q9 guideline reached Step 5 in September 2006 and has been in use in various countries for over 15 years. In the revision work, feedback from experiences after QRM implementation up to now, and ideas of ICH Q10, Q12, Q14, etc. will be reflected to promote commonality of QRM concepts among regulations and industries, and additional training will be provided.