Changing Regulatory Requirements for Extractables & Leachables Testing on Pharmaceutical Packaging Systems
Information
In the past decade, scrutiny has changed in the way EMEA or FDA regulators look at Extractables & Leachables data. Requirements gradually increased without official guidance, which left the Pharmaceutical Industry in the dark. Second-guessing the current position and requirements of regulators to support a submission became the norm.
This presentation will address the following:
• Key success factors of E&L projects.
• An understanding of what regulators want and how to meet expectations.
• Facing the reality of the ever-evolving regulatory landscape, analytical testing labs need to be at the forefront with expertise in the field of Extractables and Leachables testing and state-of-the-art technology.
• Meeting development needs and requirements for the pharma industry and raising the bar for material suppliers.
• Mitigating risk through successful partnering between drug product vendors, material suppliers and the CRO performing the test.
