Extractables and Leachables: 101 - Webinar Recording/Transcript
Extractables and Leachables: 101
Once confined to the fringes of FDA regulation, extractables and leachables are now in sharp focus.
Driven by ICH Q3D guideline compliance requirements, plus a substantial shift in metal impurity standards, the FDA now expects compliance in nearly all dosage forms; and scrutiny extends to materials such as manufacturing equipment and dosing devices.
But confusion and misinformation abound. Many sponsors still run into trouble understanding and performing appropriate E&L studies, leading to costly delays and raising the risk of regulatory sanctions.
Dr. Wayland Rushing, Director of Scientific Affairs at EAG Labs, is the expert to guide you through this regulatory thicket. Dr. Rushing sorts it all out:
- Extractables and leachables: What they are, special issues they pose
- Regulatory requirements: ICH Q3D guideline requirements and more
- Designing an E&L program: What to consider
- Analytical challenges associated with E&L
- And much more!
Dr. Rushing’s 15-year career has focused on CMC development programs for a wide array of biopharmaceutical clients including parenterals, inhalation drugs and other pharmaceuticals with complex delivery systems. Let him help you get into full compliance.