Wednesday 21 June 2017

Test for Abnormal Toxicity

The scientific validity and rationale of the test for abnormal toxicity has been the subject of debate for some time in Europe. The test was originally developed for detecting external contaminants in biological products, but over time the introduction of Good Manufacturing Practices and the use of appropriate and stringent Quality Control measures have rendered their use less necessary. Current scientific evidence suggests that, in light of such debatable relevance, the omission of the test for abnormal toxicity would not compromise the safety of biological medicines.

The European Pharmacopeia is considering the possible deletion from the European Pharmacopoeia. The European Pharmacopoeia Commission is seeking public feedback on its proposal to remove the requirements for a test for abnormal toxicity from 49 monographs of the European Pharmacopoeia (Ph. Eur.).

This consultation will run until June 2017 for all users, and will be extended until August for National Pharmacopoeia Authorities.


Posted by Dr. Tim Sandle

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