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Zoekresultaten - 7 results
Advanced Analysis of Biopharmaceuticals: Endotoxin content & Sterility testing
Vaccines and other Biologics 9-12 December, 2024, virtual Webinair, EMA, virtual (2024) Keywords: Vaccine- OMCL- lot release Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot ...
Implementing the 3RS in quality Control and batch release testing- view from a Belgian OMCL
Publication Type: Scientific poster, presentation or proceeding Authors: Florens, M.; Tesolin, L. Source: AFMPS- Advancing the 3Rs for Regulatory Testing of Medicines-31/01/2024-Antwerpen, Belgium, ...
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.
release testing that must be carried out by the manufacturer for each single batch. The Directives require Member States to recognize Official Control Authority Batch Release carried out by other Member ...
Testing of expired Synflorix bulks: actions taken by three OMCLs and concerns raised by another OMCL.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Brussels, Belgium (2015) Keywords: batch release meeting TESTING ...
Release testing by manufacturers & Ph.Eur. compliance: lessons learnt for competent authorities. A case study: the Extractable Volume
study case-study compliance meeting Release testing study TESTING Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Efficacité et sécurité des vaccins, ...
Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).
tests already performed by the manufacturer need to be repeated by an OMCL (Official Medicines Control Laboratory) before a release certificate for this specific batch can be granted. In general, testing ...
Testing and release of Synflorix ® monovalent conjugated bulks: update after 1 year of a complex vaccine with complex testing
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Split, Croatia (2010) Keywords: a meeting Release testing ...