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

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Current effective version

Adopted guideline

Reference numberCHMP/BWP/452081/07
Effective from01/11/2009
KeywordsPlasma derived medicinal products, rabbit pyrogen testing, bacterial endotoxin test, LAL test, monocyte activation test
DescriptionThis 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.

Document history

First version

Current version

Adopted guideline

Overview of comments

Draft guideline

In operation: 01/11/2009–present

Published: 23/04/2009

Published: 05/12/2007

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