Monday, 17 November 2014

Pyrogen testing – European Pharmacopeia

The Ph. Eur. is proposing an amendment for the pyrogen test monograph (2.6.8). The only change is in directing users to consider using an alternative to the rabbit model.

The change states:

“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).”

Interestingly, the recommendation is towards the MAT rather than LAL testing.

The proposal has been added to Pharmeuropa 26.4.

 Posted by Tim Sandle