Extractables & Leachables in Transition: Toward a Unified Risk-Based Approach
Day 1 Manufacturing 5.0 Stage
06/10/2026 14:45 - 15:10pm
Contributors
Margherita Monico : E&L Senior Project Manager - Mérieux NutriSciences
Extractables & Leachables (E&L) studies are essential to assess the safety and compatibility of packaging materials, delivery systems, and process components. However, evaluating the safety and compatibility of materials through E&L studies has long been challenged by a fragmented regulatory landscape. Today, the regulatory scenario is evolving. Join us as we explore how recent standards, such as ICH Q3E and USP <665>, are introducing a structured, risk-based approach to streamline E&L strategies into a coherent, unified framework.