Understanding The Regulatory Landscape For Ophthalmic Drug Products

This presentation explores the evolving regulatory landscape for ophthalmic drug products and the challenges developers face in meeting stringent quality and contamination control requirements. Topics include USP <789> particulate limits, the impact of the revised EU GMP Annex 1, and the importance of implementing a comprehensive Contamination Control Strategy (CCS).

Viewers will gain insight into common ophthalmic drug development challenges, including particulate control, silicone oil concerns, and endotoxin management, while learning how purpose-built packaging and delivery solutions can support compliance, product quality, dose accuracy, and patient safety. The session also highlights ophthalmic-specific packaging technologies designed to minimize contamination risks and support a robust CCS approach.

Key takeaways include understanding regulatory requirements unique to ophthalmic drug products, interpreting USP <789> limits for intraocular applications, developing an effective CCS, and evaluating packaging solutions that support safe and effective ophthalmic drug delivery.