The consistency approach for the quality control of vaccines

被引：48

作者：

Hendriksen, Coenraad ^{[1
,2
]}

Arciniega, Juan L. ^{[3
]}

Bruckner, Lukas ^{[4
]}

Chevalier, Michel ^{[5
]}

Coppens, Emmanuelle ^{[5
]}

Descamps, Johan ^{[6
]}

Duchene, Michel ^{[6
]}

Dusek, David Michael ^{[7
]}

Halder, Marlies ^{[8
]}

Kreeftenberg, Hans ^{[1
]}

Maes, Alexandrine ^{[9
]}

Redhead, Keith ^{[10
]}

Ravetkar, Satish D. ^{[11
]}

Spieser, Jean-Marc ^{[12
]}

Swam, Hanny ^{[13
]}

机构：

[1] Netherlands Vaccine Inst, NL-3720 AL Bilthoven, Netherlands

[2] Univ Utrecht, Netherlands Ctr Alternat Anim Use, NL-3508 TB Utrecht, Netherlands

[3] US FDA, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA

[4] Inst Virol & Immunoprophylaxis, CH-3147 Mittelhausern, Switzerland

[5] Sanofi Pasteur, F-69280 Marcy Letoile, France

[6] GlaxoSmithKline Biol, B-1330 Rixensart, Belgium

[7] USDA, Ctr Vet Biol, Anim & Plant Hlth Inspect Serv, Ames, IA 50010 USA

[8] European Commiss, Joint Res Ctr, European Ctr Validat Alternat Methods, Inst Hlth & Consumer Protect, I-21020 Ispra, Italy

[9] Sci Inst Publ Hlth, B-1050 Brussels, Belgium

[10] Intervet UK Ltd, Milton Keynes MK7 7AJ, Bucks, England

[11] Serum Inst India Ltd, Pune 411028, Maharashtra, India

[12] Council Europe, European Dept Quality Med, F-67081 Strasbourg, France

[13] Intervet Int BV, NL-5830 AA Boxmeer, Netherlands

来源：

BIOLOGICALS | 2008年 / 36卷 / 01期

关键词：

Vaccines; quality control; consistency; release testing; in vitro;

D O I：

10.1016/j.biologicals.2007.05.002

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Current lot release testing of conventional vaccines emphasizes quality control of the final product and is characterized by its extensive use of laboratory animals. This report, which is based on the outcome of an ECVAM (European Centre for Validation of Alternative Methods, Institute for Health and Consumer Protection, European Commission Joint Research Centre, Ispra, Italy) workshop, discusses the concept of consistency testing as an alternative approach for lot release testing. The consistency approach for the routine release of vaccines is based upon the principle that the quality of vaccines is a consequence of a quality system and of consistent production of lots with similar characteristics to those lots that have been shown to be safe and effective in humans or the target species. The report indicates why and under which circumstances this approach can be applied, the role of the different stakeholders, and the need for international harmonization. It also gives recommendations for its implementation. (C) 2007 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

引用

页码：73 / 77

页数：5

共 13 条

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