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Zoekresultaten - 62 results
Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).
Tetanus time toxicity use vaccine vaccines VALIDATION Validation study Weight Weight gain Weight-gain world Abstract: For the batch release of vaccines on the European market, a limited number of quality ...
Testing and release of Synflorix ® monovalent conjugated bulks: update after 1 year of a complex vaccine with complex testing
TESTING vaccine Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des vaccins et produits sanguins Kwaliteit van vaccins en bloedproducten ...
Collaborative study for the standardisation of the histamine sensitizing test in mice and the CHO cell-based assay for the residual toxicity testing of acellular pertussis vaccines.1
Pharmacopoeia (Ph. Eur.) and the World Health Organisation (WHO) require the performance of extensive quality and safety control testing before the release on the market of vaccine products for human use. Safety ...
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 ...
The batch release procedure in Europe; manufacture and control of vaccine adjuvants; bacterial and polysaccharide vaccines
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: ULB dept Pharmacy (2021) Health Topics: Effectiveness and safety of vaccines, medicines and health ...
Panel discussion on the adoption of 3Rs and non-animal approaches for quality control and batch release testing of these products
-who-guidelines-understanding-impact-quality-control-and, https://www.nc3rs.org.uk/, Virtual conference, London, United Kingdom (2022) Keywords: 3Rs regulatory hurdles Vaccine quality control Health Topics: Effectiveness and safety of vaccines, medicines and health products- ...
Good Practices for Batch Release
(2023) Keywords: Vaccine- OMCL- lot release Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins ...
Viewpoint or an EU OMCL on OCABR and Batch Release fro outside the EU
Publication Type: Scientific poster, presentation or proceeding Authors: Geneviève Waeterloos Source: EU batch release for Human Vaccines: A practical overview for newcomers to the system, EDQM, ...
Batch release procedure & Activities of the service Quality of vaccines and blood products
release- Procedure Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, médicaments et produits de santé- ...
Replacement, Reduction and Refinement (3Rs): Network Strategies
Publication Type: Scientific poster, presentation or proceeding Authors: Geneviève Waeterloos; Morgane Florens Source: EU batch release for Human Vaccines: A practical overview for newcomers to the ...