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EU Annual report: batch release of human vaccines

Domicent, C.; Auquier, J.; Laurent, F.; Lamme, J.; Cuignet, L.; Desmet, N.; Stradiot, L. Source: Sciensano, Brussels, Belgium, p.261 (2024) Keywords: OMCL vaccine- quality control- analytical results Vaccine ...

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 ...

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

products derived from human plasma by an Official Medicines Control Laboratory (OMCL) before these can be marketed. A Batch Release Certificate is issued when the results are satisfactory. This is known as ...

Best Practices: Out of Specification Results

Bangkok, Thailand (2023) Keywords: vaccine- quality control- analytical results Health Topics:  Vaccin Vaccin Vaccin Service:  Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten ...

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