ICH Q9: Quality Risk Management Revisions on Horizon

International Council for Harmonisation of Technical Requirement for Pharmaceuticals for Human Use (ICH) is considering revising portions of Quality Guideline No. 9: Quality Risk Management (Q9), though the guideline as a whole will not be rewritten, according to Stephan Roenninger, PhD, Director Quality External Affairs, Amgen. He spoke on “15 Years of ICH Q9: Practical Implementation & Pitfalls” at the 2019 PDA Risk Management in the Regulatory Landscape Conference in Washington, D.C., Dec. 10.