Official testing of immunological veterinary medicinal products

被引：0

作者：

Jungbaeck, C. ^{[1
]}

Motitschke, A. ^{[1
]}

机构：

[1] Paul Ehrlich Inst, Bundesinst Impfstoffe & Biomed Arzneimittel, D-63225 Langen, Germany

来源：

BUNDESGESUNDHEITSBLATT-GESUNDHEITSFORSCHUNG-GESUNDHEITSSCHUTZ | 2014年 / 57卷 / 10期

关键词：

OBPR/OCABR; OMCL network; Immunological veterinary medicinal products; Mutual recognition; Batch testing;

D O I：

10.1007/s00103-014-2036-y

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

The testing of immunological veterinary medicinal products (IVMPs) by official medicines control laboratories (OMCLs) is an important contribution to the control of quality, safety and efficacy of these products. Based on the legislation of the European Union (EU) and with the support of the European Directorate for the Quality of Medicines & HealthCare (EDQM) a network of OMCLs of the EU member states and Switzerland has been built. This network has established its own rules allowing the mutual recognition of test results and rapid communication of details regarding batch release or rejection. Annual reports, OMCL meetings and collaborative studies help to foster confidence between the OMCLs. The procedure for official testing is described and an overview of deficits found at testing is presented in the paper. The testing of selected batches of centrally authorized products is also performed by OMCLs and is briefly described. Communication both among OMCLs and with pharmaceutical industry is an important part of the OMCLs' work to compare test results and to optimize existing or develop new test methods. Several OMCLs are also pursuing the development of new test methods, primarily for the reduction, refinement and replacement of animal experiments in routine testing.

引用

页码：1193 / 1197

页数：5

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