Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).

Last updated on 22-8-2019 by Anonymous (not verified)

Scientific poster, presentation or proceeding




For the batch release of vaccines on the European market, a limited number of quality tests already performed by the manufacturer need to be repeated by an OMCL (Official Medicines Control Laboratory) before a release certificate for this specific batch can be granted. In general, testing on animals is only required for pre-clinical studies in order to test the toxicity of the drug substance and not for routine batch release. However, for some biological medicinal products in general and vaccines in particular, the quality cannot fully be assessed by physicochemical testing alone and theref…

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