USP 382 – Packaging QC : A new chapter applicable from December 1st 2025

📃 Since December 2025, USP <382> introduces a more comprehensive approach to evaluating packaging systems.

This marks a significant shift : analysis is no longer limited to individual components in isolation but is now based on an assessment of the packaging and delivery system as a whole, under conditions representative of its intended final use.

The objective is to ensure that the packaging adequately protects the product by maintaining its sterility and integrity throughout its lifecycle, from storage and transport to administration. This approach incorporates real-use conditions, clinical simulation, risk assessment, and scientifically justified of acceptance criteria.

🎯 Manufacturers must now demonstrate :

• The integrity of the system
• Its functional performance
• Its reproducibility
• And its robustness under conditions of use

🤝 CEBIPHAR supports you in meeting these new regulatory expectations, particularly in the evaluation of the functional performance of parenteral packaging systems under real conditions of use and in Container Closure Integrity (CCI) strategies.

📩 Our teams are available to discuss your challenges, contact us !