Changing FDA Requirements for Extractables & Leachables testing on Pharmaceutical Packaging Systems
The FDA Draft Guidance “Container/Closure Systems for Packaging Human Drugs and Biologics” was issued in 1999. But in the past decades, there has been a change in the scrutiny of the way FDA reviewers looked at E&L data. They have gradually increased the requirements, not backed up with any official document (Guidance, guideline…) which left the Pharmaceutical Industry in the dark, second guessing of what the current position and requirements were of the FDA to support a submission.
In this presentation, the key factors of success of any given E&L project will be highlighted. Crucial is to understand what regulators really want and aligning the design space of an E&L study to their expectations.
Facing the reality of the ever-evolving regulatory landscape, analytical testing labs need to be on the forefront with expertise in the field of extractables and leachables testing and state-of –the art technology. Meeting the development needs and requirements, of the pharmaceutical and biopharmaceutical industries, also raises the bar for material suppliers.
Only through successful partnering between drug product vendors, material suppliers and the CRO performing the test, a true mitigation of the risk related to packing can be established.