Replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products - Scientific guideline

This document lays down the requirements to be addressed in any justification for use of a test for bacterial endotoxins as an alternative to a test for pyrogens for plasma derived medicinal products. It specifically, addresses the LAL-testing related issues, process related considerations, clinical considerations and regulatory aspects to be considered when replacing the test for pyrogens by an alternative test.

Keywords: Plasma derived medicinal products, rabbit pyrogen testing, bacterial endotoxin test, LAL test, monocyte activation test