Free Webinar | Extractables & Leachables in practice: ICH Q3E, USP <665> and risk-based assessment

Extractables and leachables (E&L) studies are essential for assessing the safety and compatibility of pharmaceutical packaging, delivery systems, and manufacturing components. Yet designing an effective E&L strategy has long required companies to interpret fragmented regulatory, compendial, and industry expectations.

Today, this landscape is evolving. The draft ICH Q3E guideline introduces a holistic framework for E&L assessment and control, while USP <665> provides a risk-based approach for plastic components and systems used in pharmaceutical and biopharmaceutical manufacturing. During this webinar, Mérieux NutriSciences experts will connect these developments with the practical decisions required to build robust and proportionate E&L strategies.

During the webinar, we will discuss:

• The current E&L regulatory and compendial landscape
• The scope and key principles of the draft ICH Q3E guideline and USP <665>
• How risk assessment can guide the extent and design of E&L studies
• The relationship between packaging, delivery systems, and manufacturing components
• Practical considerations for aligning E&L strategies with evolving expectations

About the speaker

Margherita Monico is E&L Senior Project Manager at Mérieux NutriSciences, where she designs and supervises Extractables & Leachables studies. She holds a degree in Veterinary Medicine from the University of Padua and a Master’s in Biotechnology for Business from CUOA Business School, and regularly delivers tailored E&L courses and webinars.