Understanding the Regulatory Landscape for Ophthalmic Drug Products: Contamination Control Strategies, USP , and Purpose-Built Solutions

Ophthalmic drugs face strict regulations, including USP limits on particulate matter and updated EU GMP Annex 1 requirements for comprehensive Contamination Control Strategies (CCS). These standards emphasize minimizing contamination across packaging, sterilization, and system controls.

This webinar explores how these regulations impact real-world development challenges and how purpose-built packaging—featuring low particulates, silicone-free designs, and advanced barrier technologies—can support compliance, improve dose accuracy, and reduce risk.

You’ll learn:
– The role of CCS in reducing contamination risks
– Key regulatory requirements, including USP
– Common challenges like particulates, silicone oil, and endotoxins
– Packaging solutions for safer ophthalmic drug delivery

Key takeaways:
– Build an effective CCS
– Understand ophthalmic vs. injectable requirements
– Interpret USP limits
– Evaluate solutions for compliant drug delivery