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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).
reality, EDQM, Issue European Directorate for the Quality of Medicines & HealthCare (EDQM),Council of Europe, Number 99, Prague, Czech Republic, p.98- 99 (2010) Keywords: 2001 a an Animal Animals AS at ...