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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