Chargenprüfung als wesentliche Säule der Versorgung mit sicheren und wirksamen Impfstoffen

The Paul-Ehrlich Institute (PEI) plays a central role in the release of vaccines in Germany as well as Europe. The experimental testing and release of each vaccine batch is carried out according to the procedures and regulations of the Official Control Authority Batch Release (OCABR) and the German...

Descripción completa

Detalles Bibliográficos
Autores principales: Sediri-Schön, Hanna, Lange, Jeannette, Grabski, Elena, Wagner, Ralf, Hildt, Eberhard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2022
Materias:
Leitthema
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9582401/
https://www.ncbi.nlm.nih.gov/pubmed/36264321
http://dx.doi.org/10.1007/s00103-022-03611-1
Descripción
Sumario:The Paul-Ehrlich Institute (PEI) plays a central role in the release of vaccines in Germany as well as Europe. The experimental testing and release of each vaccine batch is carried out according to the procedures and regulations of the Official Control Authority Batch Release (OCABR) and the German medicine act paragraph 32. The independent testing aims to demonstrate the conformity of quality criteria set in the marketing authorization for each lot produced. This article illustrates both the batch release procedure in general and specifically for the newly developed and approved COVID-19 vaccines during the COVID-19 pandemic.

Ejemplares similares