A Plant for the Manufacturing of Virus Inactivated Plasma According to GMP-Guidelines

Fresh Frozen Plasma (FFP) is prepared in blood banks throughout the world, as a separation product of whole blood. The viral safety of FFP depends on donor selection and screening. Despite implementation of measures a definite residual risk of virus transmission still remains. Estimates of residual risk vary, and depend upon the prevalence of infection within the country, the stability of the donor population and the sensitivity and specificity of the test kits used.