title: The consistency approach for the quality control of vaccines.
abstract: 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.
authors: Netherlands Vaccine Institute, A. van Leeuwenhoeklaan 11, 3720 AL Bilthoven, The Netherlands.
authors: Coenraad
authors: C
authors: Hendriksen
authors: Juan L
authors: JL
authors: Arciniega
authors: Lukas
authors: L
authors: Bruckner
authors: Michel
authors: M
authors: Chevalier
authors: Emmanuelle
authors: E
authors: Coppens
authors: Johan
authors: J
authors: Descamps
authors: Michel
authors: M
authors: Duchêne
authors: David Michael
authors: DM
authors: Dusek
authors: Marlies
authors: M
authors: Halder
authors: Hans
authors: H
authors: Kreeftenberg
authors: Alexandrine
authors: A
authors: Maes
authors: Keith
authors: K
authors: Redhead
authors: Satish D
authors: SD
authors: Ravetkar
authors: Jean-Marc
authors: JM
authors: Spieser
authors: Hanny
authors: H
authors: Swam
mesh_terms: D000818:Animals; D006801:Humans; D011786:Quality Control; D014612:Vaccines / Q000592:standards*
chemical_list: D014612:Vaccines