When Should You Start Your E&L Studies?

Is it Ever Too Soon To Start Your Extractables and Leachables Assessment?

Extractables and leachables assessments of pharmaceutical packaging and delivery systems are critical to both your development and regulatory submissions.

A complete extractables and leachables assessment is a significant process. Starting the assessment as soon as manufacturing and packaging components are finalized is critical to allowing a sponsor’s team time to demonstrate to the regulatory authorities that all materials used for the manufacturing, containment, and delivery are compatible with the drug product. Compressing the timeline can, at best, impact the sponsor’s confidence in their own risk assessment or, at worst, impact a regulator’s confidence in the risk assessment.

Putting off your Extractables and Leachables Assessment can lead to increased costs and delays

As long as the materials are finalized, it’s never too soon to start your extractables and leachables assessment.

Click the button below to download the white paper from Adelphi Partner, West Pharmaceutical Services, for expert advice on what you need to know before planning for your extractables and leachables testing programs.