Lessons Learned: Real-World Impurity Management

Drawing on their collective experience, the panel reflects on the most common and costly mistakes seen in nitrosamine impurity management programs, and what organizations could do differently. The discussion covers both the strategic errors—such as underestimating the scope of the problem or deferring action—and the more technical pitfalls encountered during method development, remediation, and control strategy implementation. The panelists share their views on what an effective remediation process looks like when a nitrosamine issue is discovered late in development or post-approval, and what the biggest traps are for organizations navigating that situation. The segment offers a candid and practical perspective on what separates well-managed programs from those that struggle.

Moderated by Joseph Lackey, Technical Manager at LGC Standards, the discussion brings together Jason Brown, Principal Consultant at Brown Pharma Consulting Ltd, Maria Kristina Parr, a professor in pharmaceutical chemistry from the Freie Universität Berlin, Jörg Schlingemann, Director, Principal Expert Quality Control Systems at Merck Healthcare KGaA, and George Johnson, an associate professor at Swansea University.