The upcoming implementation of USP 1664.2 on November 1, 2025, marks a significant shift in regulatory expectations for pharmaceutical companies, particularly those involved in the development and manufacturing of parenteral drug products.
To ensure compliance, organisations must take proactive steps to update their Extractables and Leachables (E&L) strategies. This includes expanding the scope of assessments to cover manufacturing equipment, reassessing risk profiles for injectable products, conducting comprehensive E&L studies using validated analytical methods, and providing robust toxicological justifications. Clear documentation and alignment with regulatory expectations will be essential for successful submissions.
The period leading up to the effective date offers a valuable opportunity for preparation. Companies should use this time to thoroughly review the new requirements, identify any gaps in current practices, and initiate the necessary studies and validations.
Staying ahead of these changes is critical—not only for regulatory compliance but also for ensuring product safety and maintaining efficient, science-driven testing protocols. This webinar brings together industry experts to clarify the latest updates, share practical insights, and explore how organizations can adapt effectively.Whether your role is in regulatory affairs, analytical testing, product development, or quality assurance, this session is designed to equip you with the knowledge and tools needed to navigate USP 1664.2 with confidence.
Agenda:
Daniele Zarini, Team Leader Pharma, Eurofins Regulatory & Consultancy Services Italy
Francesco Tessari, E&L Technical Advisor, Eurofins BioPharma Product Testing Italy