[批量检测作为安全有效疫苗供应的重要支柱]
[Batch testing as an essential pillar of the supply of safe and effective vaccines].
作者信息
Sediri-Schön Hanna, Lange Jeannette, Grabski Elena, Wagner Ralf, Hildt Eberhard
机构信息
Abteilung Virologie, Paul-Ehrlich-Institut, Langen, Deutschland.
Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Abteilung Virologie, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland.
出版信息
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2022 Dec;65(12):1244-1250. doi: 10.1007/s00103-022-03611-1. Epub 2022 Oct 20.
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.
保罗·埃利希研究所（PEI）在德国乃至欧洲的疫苗放行方面发挥着核心作用。每一批疫苗的试验检测和放行均按照官方控制机构批签发（OCABR）的程序和规定以及德国药品法第32条进行。独立检测旨在证明所生产的每一批产品符合上市许可中规定的质量标准。本文阐述了一般的批签发程序，特别是在新冠疫情期间新研发并获批的新冠疫苗的批签发程序。
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