EMEA Publishes Guideline on Replacement of Rabbit Pyrogen Testing

Over the last ten years, the importance of alternative pyrogen testing methods for the pharmaceutical industry has increased considerably, because they provide an opportunity to reduce time and a possibility to close the gaps of the classic methods of rabbit testing and LAL. During this period, there was a lot of confusion and a great uncertainty about the implementation and the regulatory requirements of such new technologies.

Now, the European Medicines Agency published the new "GUIDELINE ON THE REPLACEMENT OF RABBIT PYROGEN TESTING BY AN ALTERNATIVE TEST FOR PLASMA DERIVED MEDICINAL PRODUCTS" in April. The purpose of this guidance is to highlight points to be addressed in any justification for using a test for bacterial endotoxins as an alternative to a test for pyrogens for medicinal products derived from human blood and human plasma.

This Guideline is the result of scientific work to close the gaps in the classic pyrogen testing (rabbit testing and Limulus polyphemus amoebocyte Lysate-test (LAL-test)), like possible interferences between constituents (e.g. several plasma proteins) of plasma-based products and some LAL methods or the non-detection of fever inducing cytokines.

This guideline also covers plasma derivatives used as:

  • Excipients
  • Ancillary substances in medical devices (Directive 2000/70/EC amending Directive 93/42/EEC)
  • Investigational products as such or as excipients

More details can be found here.

The ECA Conference “Endotoxin and Pyrogen Testing” in Berlin, Germany on 25-26 June 2009 will provide an update on alternative testing methods today and introduce experiences from pharmaceutical companies with the classic methods like rabbit testing and LAL in different uses. The speakers team will support you with information about regulatory requirements and approval processes, practical knowledge in implementing the methods as well as future expectations relative to Endotoxin and Pyrogen testing. You will find more information at www.pyrogen-conference.com.

Axel H Schroeder
On behalf of the European Compliance Academy (ECA)

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