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Requirements for safety and quality of intravenous immunoglobulin G preparations.
  1. G H Rütter
  1. Serapharm Division of Research and Development, Münster, Germany.

    Abstract

    The increasing use of intravenous immunoglobulin-G preparations (IVIg) calls for evaluation of the requirements for quality and freedom from infection. The WHO Requirements dating from 1982 have been surpassed by the majority of IVIg preparations. Three methods are used for ensuring safety from infection: the restrictive choice of donor, the precise introductory screening of every individual blood or plasma donation, and the additional active virus inactivation procedures that surpass the virus elimination of, for example, the Cohn-fractionation method. Although it is highly improbable that IVIg can transfer infections, this possibility cannot be completely ruled out even when all the GMP (good manufacturing practice) rules are observed most carefully. Increased safety from infection would be provided if blood and plasma donations were obtained nationally from unpaid voluntary donors and if an additional active viral inactivation procedure was introduced.

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