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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.

Certificate when the results are satisfactory. This is known as “Official Control Authority Batch Release” (OCABR) and consists of analytical controls and document review which are additional to the routine ...

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

of ten mice. Implementing this reduced number of mice per test at IPH also resulted in a substantial reduction in the use of laboratory animals. To conclude, since IPH started in 1989 with the ...

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