[Viral safety concept: application to blood and blood products].
Safety of blood and its derivatives, with regards to the risk of transmission of infectious agents such as viruses or non conventional agents, relies on a series of general principles for which national and European guidance and regulations have been drawn and regularly updated. Three main criteria contribute to the safety of these products: knowledge and control of the quality of blood or plasma as the starting material, the efficiency of the manufacturing process to remove/inactivate adventitious agents, and the testing done during the production process. In addition, vigilance routinely exercised on the products used in daily practice increases the confidence in these health products.
Trouvin
Jean-Hugues
JH
Direction de l'évaluation des medicaments et produits biologiques (Demeb), Agence française de sécurité sanitaire des produits de santé (Afssaps), 143, boulevard Anatole France, 93285 Saint-Denis Cedex. Jean-Hugues.TROUVIN@afssaps.sante.fr
D001688:Biological Products / Q000592:standards*; D001782:Blood Donors; D001803:Blood Transfusion / Q000592:standards; D006801:Humans; D011634:Public Health; D012308:Risk Management; D012449:Safety; D014777:Virus Diseases / Q000517:prevention & control*
D001688:Biological Products