Ph.Eur Chapter 2.6.8. Pyrogens Revision open for Comments

Related to the current state of the art, Directive 2010/63/EU revising Directive 86/609/EEC on the protection of animals used for scientific purposes was adopted on 22 September 2010. The Directive is firmly based on the principle of the Three "Rs", to replace, reduce and refine the use of animals used for scientific purposes. After a transition of two years, it should be implemented in the member states.

This directive effects the classic rabbit test used for pyrogen detection in medicinal products. In accordance with the provisions of the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes, tests must be carried out in such a way as to use the minimum number of animals and to cause the least pain, suffering, distress or lasting harm. Wherever possible and after product-specific validation, the pyrogen test is replaced by the monocyte-activation test (2.6.30).

In Pharmeuropa Issue 26.4, the EDQM published the revised chapter 2.6.8. Pyrogens. It includes information about selection of animals, animals quarters, materials, Thermometers, preliminary and main tests and interpretation of results. The document is open for comments until 31. December 2014.

The complete revision can be found Pharmeuropa, Issue 26.4. The online version can be accessed on the EDQM website. Access to the online version requires registration, but this is a free service.

Representatives of the European Authorities as well as of the FDA will present the current developments at the Endotoxin and Pyrogen Testing Conference on 19 and 20 November in Düsseldorf/Neuss, Germany.

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