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.

Technical Report No. 54-6 includes:

• Evaluations that can be used to provide an overall view of the risk question, “Is the excipient fit for use?”
• A generic risk assessment model and a holistic strategy applicable to excipient use for all dosage forms
• Discussion of end-to-end supply chain risks and information gathering
• Control strategy: benefits and challenges

Technical Report No. 54-6 is a response to 2015 European Commission guidelines on risk assessments for excipients. In 2018, PIC/S incorporated these same provisions for formalized risk assessment into a publication of the same name, extending the provisions to have global applicability. The technical report is grounded in the general principles outlined in ICH Q9: Quality Risk Management. Technical Report Series 54 is part of PDA’s collection of QRM-centered technical reports.

Technical Report 54-6: Formalized Risk Assessment for Excipients is available in the PDA Bookstore.