DRUG CONTAINING ONE OR MORE PLASMA DERIVATIVES, A QUALITY-ASSURED PLASMA STARTING MATERIAL FOR THE SAME AND A METHOD FOR THE PREPARATION OF THE DRUG

摘要

A drug containing one or more plasma derivatives as active substance or auxiliary ingredient, characterized in that the starting material or the intermediates incurred in the preparation of the plasma derivatives are not contaminated by viruses or whose virus load of one or more hematogenous viruses capable of repreduction does not exceed a defined limiting value, the absence of contamination by certain hematogenous viruses capable of reproduction being determined by an excess of virus-neutralizing antibodies in the starting material or in the intermediate, or by a protective immunity of the plasma donor at the time of the plasma donation, otherwise the genome equivalents of the respective viruses of interest in the starting material or in the intermediate being determined by a quantifiable controlled and non-inhibited method for the detection or determination of nucleic acids, the thus quality-assured starting material or intermediate, respectively, for the preparation of the finished plasma derivative being subjected to at least one substantial virus depletion or virus inactivation step, and the finished quality- assured plasma derivative obtained being worked up to a drug by known methods.