As of December 1, 2025, USP <382> is officially in effect and teams across the industry are now navigating the requirements for system-level functional suitability and deterministic container closure integrity testing.
In our recent webinar, we discussed how critical it is to evaluate your packaging systems under the new standard. Now that the deadline has passed, the focus shifts to demonstrating active compliance and addressing any remaining gaps.
Key Points Moving Forward:
• System-level functional testing is now mandatory
• Deterministic CCIT is required for sterility assurance and regulatory success
Missed the Webinar? Access Here
With the USP <382> deadline behind us, Gateway Analytical will continue to support pharmaceutical teams in:
• Completing post-deadline gap assessments
• Implementing deterministic CCIT programs
• Executing system-level functional suitability testing
• Preparing regulatory-ready technical documentation
Stay ahead of compliance challenges. Trust the experts at Gateway Analytical to guide your compliance strategy. Our team bridges regulatory and technical gaps through system-level analytical testing, USP <382> functional suitability assessments, and deterministic CCIT programs. Contact our team anytime via phone at (724) 443-1900 or send us an email at in**@***************al.com.
