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Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.

mutual recognition. Although the process of batch release in Europe is straightforward and clearly laid down in directives, it is sometimes a lengthy process. More than one year should sometimes be taken into account ...

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

batch release Belgium Case Cell challenge Control data Diphtheria DRUG European Gain general health Healthy implementation in vivo Institute IS IT Laboratories measure measures medicinal product Medicine ...

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