Extractables, Leachables, And Risk: Ensuring Safety In Pharma Manufacturing

In today’s regulatory landscape, pharmaceutical and biopharmaceutical manufacturers are under growing pressure to ensure safety and compliance, particularly around extractables and leachables (E&L). Navigating USP requirements, defining testing needs, and assessing risk can seem complex, but it doesn’t have to be uncertain.

This expert-led webinar will outline a clear, step-by-step framework for E&L risk assessment — from component selection to risk scoring and characterization level assignment — while also providing practical strategies to reduce testing requirements through effective mitigation, all within regulatory expectations. Designed for teams developing new products, refining processes, or preparing for submissions, the session will equip attendees with tools to take a more structured, efficient, and compliant approach to E&L management.

Key takeaways include how to evaluate applicable materials and determine the appropriate level of characterization, apply a structured method for assigning risk scores, and implement mitigation strategies that can minimize testing needs for specific components.