Merkle A, Lechner H, Oppling V, Meyer H
Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2014 Oct;57(10):1188-92. doi: 10.1007/s00103-014-2037-x.
Vaccines are biologicals. This group of medicinal products is produced with a predefined variability based on the biological starting materials used. Vaccines are subject to official control authority batch release performed by the Paul-Ehrlich-Institut (PEI). To release batches to the market, experimental testing has to be conducted by an official medicines control laboratory as the PEI. It is the aim of this independent testing to demonstrate the conformity of quality criteria with conditions set in the marketing authorization for each lot produced. The testing is performed on the basis of vaccine specific batch release guideline and due to the difficult and time consuming testing procedures often run in parallel with manufacturers testing. If test results comply with the predefined criteria, the lot in question is released. This article describes the challenge of official control authority batch release testing of two complex combination vaccines.
疫苗属于生物制品。这类药品是基于所使用的生物起始原料，以预先确定的变异性生产出来的。疫苗需由保罗·埃利希研究所（PEI）进行官方控制机构的批签发。为将批次投放市场，必须由作为PEI的官方药品控制实验室进行实验检测。这种独立检测的目的是证明每个生产批次的质量标准符合上市许可中规定的条件。检测是根据疫苗特定的批签发指南进行的，并且由于检测程序困难且耗时，通常与制造商的检测并行开展。如果检测结果符合预定标准，则相关批次予以放行。本文描述了两种复杂联合疫苗的官方控制机构批签发检测所面临的挑战。
