Regulatory Roundup: ICH Workshop Addresses Quality Systems
ePT--the Electronic Newsletter of Pharmaceutical Technology
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.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
