On December 1, 2025, USP <382> will replace USP <381> and require system-level functional suitability testing of elastomeric components in vials, syringes, cartridges, and infusion systems. At the same time, EU GMP Annex 1 mandates validated deterministic container closure integrity testing and specifies that visual inspection alone is not acceptable as a method of proving closure integrity. Together, these changes create a convergence of standards that, if overlooked, risk stalled submissions, failed inspections, and product launch delays.
This webinar will explain the practical impact of USP <382> and its companion chapter <1382>. The session will outline how the requirements differ from USP <381>, what categories of functional suitability testing are in scope, and why elastomer performance must be assessed at the system level. Attendees will gain clarity on where regulatory expectations are shifting and what factors will need to be justified under the new framework.
The webinar will also address the sterility assurance expectations of Annex 1 and its direct connection to USP <1207> deterministic CCIT. Annex 1 specifies that visual inspection, while still required for defect detection, is not acceptable as a method of proving container closure integrity. By highlighting common blind spots, from sample size requirements to sponsor-defined criteria, the session will provide a clear roadmap for companies to evaluate gaps, align with regulatory expectations, and integrate packaging and integrity strategies in parallel.
Join us for this webinar to gain clear, actionable insights into how USP <382> and Annex 1 are creating a unified compliance expectation. Companies that align early will be positioned for compliance and sterility assurance, while those that delay risk regulatory gaps at launch. Register today to ensure your team is informed and ready for the changes ahead.
Key Learning Objectives
- Understand the regulatory shift from USP <381> to USP <382> and its impact on elastomeric packaging components.
- Gain clarity on how USP <1382> guides the design of functional suitability programs, including study scope and justification requirements.
- Recognize how Annex 1’s sterility assurance expectations align with USP <1207> deterministic CCIT methods.
- Identify common blind spots in readiness planning and practical steps companies can take to avoid compliance gaps by December 2025.
