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 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.

HENDRIKSEN Coenraad;  ARCINIEGA Juan;  BRUCKNER Lukas;  CHEVALIER Michel;  COPPENS Emmanuelle;  DESCAMPS Johan;  DUCHÊNE Michel;  DUSEK David;  HALDER Maria;  KREEFTENBERG Hans;  MAES Alexandrine;  REDHEAD Keith;  RAVETKAR Satish D.;  SPIESER Jean-Marc;  SWAM Hanny; 

2008-02-06

ACADEMIC PRESS LTD ELSEVIER SCIENCE LTD

JRC37085

1045-1056,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC37085,   

10.1016/j.biologicals.2007.05.002,