USP <382> and Annex 1: Converging Standards for Sterile Packaging Compliance
Information
On December 1, 2025, USP <382> will replace USP <381> with system-level functional suitability testing, assessing elastomeric components within the final packaging and delivery system. At the same time, EU GMP Annex 1 mandates validated deterministic CCIT and rejects visual inspection as an integrity method. These standards, often discussed separately, are now establishing a unified set of expectations for elastomer functionality and sterile barrier maintenance. The impact includes vials, syringes, cartridges, and infusion systems, requiring programs to synchronize testing and integrity strategies simultaneously. Companies that address USP <382> and Annex 1 together will be better positioned for compliance and sterility assurance, while those that do not risk regulatory gaps at launch.
