Viral safety evaluation of biopharmaceuticals and homoeopathic preparations of human or animal origin.
In order to meet the generally high quality requirements for the pharmaceutical manufacturing process, medicaments of animal or human origin specifically have to undergo a substantial viral safety test program. This procedure has been narrowly defined in numerous internationally valid guidelines; in addition, registration authorities are available in an advisory capacity. In order to bring about the experimental evidence, thorough planning, virological expertise and infrastructure, as well as close cooperation between process engineers and virologists, is necessary. Generally, generic studies are not accepted by the registration authorities. However, in coordination with the German Federal Institute for Drugs and Medicinal Devices (BfArM), a special arrangement for homoeopathic preparations could be agreed upon and the efficacy of selected production stages proven beyond doubt. Therefore, combined with the careful execution and evaluation of the validation studies, a high technical status for biopharmaceuticals including homoeopathic preparations guarantees a very high degree of viral safety.
Immelmann
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Virion consulting, Trills 12, 40699 Erkrath, Germany.
D000818:Animals; D001688:Biological Products / Q000592:standards*; D017277:Drug Approval; D004340:Drug Contamination / Q000331:legislation & jurisprudence; D004345:Drug Industry; D005858:Germany; D006801:Humans; D007880:Legislation, Drug; D008419:Materia Medica / Q000592:standards*; D011786:Quality Control; D015203:Reproducibility of Results; D014773:Virology; D014780:Viruses / Q000302:isolation & purification*
D001688:Biological Products; D008419:Materia Medica