PDA Letter Article

ICH Q9: Quality Risk Management Revisions on Horizon

by Rebecca Stauffer, PDA

World Management

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.