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.

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

Scientific poster, presentation or proceeding




According to the European Directives 200⅛3/EC and 2004/27/EC, EU Member States may require to test batches of immunological medicinal products or medicinal products derived from human blood or plasma by an Official Medicines Control Laboratory (OMCL) before these can be marketed. The competent authorities issue a Batch Release 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 release testing that must be carried out by the m…

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