Managing Risks In Injectable Drug Delivery: Solutions For Today's Drug Products And Tomorrow's Novel Applications

The updated EU GMP Annex 1 significantly emphasizes primary packaging. Drug manufacturers must meticulously evaluate the quality and control of materials from third-party suppliers within their Contamination Control Strategy (CCS). A supplier's robust, holistic CCS is paramount to your own success. This session will explore how West integrates a comprehensive global CCS to meet Annex 1 requirements, ensuring best practices and continuous improvement.

Driven by Annex 1 and the Medical Device Regulation (MDR), modern drug development demands advanced solutions. We'll delve into a case study on NovaPure® plungers, demonstrating how to address critical quality attributes and performance criteria. Discover how to easily access essential documentation, simplifying your MDR pathway to market.

Cell and gene therapies, including innovative vaccine technologies, are rapidly transforming healthcare. Selecting packaging materials that meet the rigorous demands of these advanced therapies is crucial. We introduce the Daikyo Crystal Zenith® Ready-to-Use Nested Vials in Tub, highlighting product features and illustrating use cases that fulfill specific requirements for this dynamic field.