Replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products
| Current effective version |
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| Reference number | CHMP/BWP/452081/07 |
| Published | 23/04/2009 |
| Effective from | 01/11/2009 |
| Keywords | Plasma derived medicinal products, rabbit pyrogen testing, bacterial endotoxin test, LAL test, monocyte activation test |
| Description | 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. |
Document history
First version Current version | In operation: 01/11/2009–present Published: 23/04/2009 Published: 05/12/2007 |