Regulatory Roundup: ICH Workshop Addresses Quality Systems

Last week, in Bethesda, Maryland, ISPE and PDA hosted a workshop on the implementation of pharmaceutical development, risk management, and quality systems as part of the ICH quality-trio workshop series. ICH Quality Implementation Working Group (IWG) leaders presented a case study based on a fictional API to demonstrate how key quality principles may be applied, including design space, control strategy, quality systems, and risk management. Approximately 400 participants-representing industry and regulators-participated in breakout sessions to discuss these applications. IWG is expected to issue official breakout reports after the third workshop is completed later this month in Japan (one workshop is being held in each ICH region-North America, Europe, Japan). The group will then decide on its next deliverables. See related blogs from the workshop at blog.PharmTech.com.