As regulatory scrutiny of nitrosamines and genotoxic impurities has intensified, pharmaceutical laboratories are under growing pressure to demonstrate not just compliance, but a deep understanding of their impurity profiles and associated risks across the product life cycle. In this Peer Exchange® from LCGC International , a panel of leading experts examine where the science and regulation currently stand, and what it takes to stay ahead of an evolving landscape.
Ep1. Meeting The Panelists
Ep2. Setting the Stage
Ep3. The Evolving Regulatory Landscape
Ep4. The Analytical Challenge: Detection, Quantification, and Method Development
Ep5. Reference Standards: The Foundation of Analytical Confidence
Ep6. Risk Assessment Strategies
Ep7. Lessons Learned: Real-World Impurity Management
Ep8. Looking Ahead: The Key Takeaways