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