The consistency approach for the quality control of vaccines

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 an...

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Bibliographic Details
Published in:Biologicals 2008, Vol.36 (1), p.73-77
Main Authors: Hendriksen, Coenraad, Arciniega, Juan L., Bruckner, Lukas, Chevalier, Michel, Coppens, Emmanuelle, Descamps, Johan, Duchêne, Michel, Dusek, David Michael, Halder, Marlies, Kreeftenberg, Hans, Maes, Alexandrine, Redhead, Keith, Ravetkar, Satish D., Spieser, Jean-Marc, Swam, Hanny
Format: Article
Language:English
Subjects:
Animals
Consistency
consistency testing
Humans
In vitro
product safety
Quality Control
Release testing
vaccine development
Vaccines
Vaccines - standards
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Summary: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.
ISSN:1045-1056
1095-8320
1095-8320
DOI:10.1016/j.biologicals.2007.05.002