Stability Testing of Medicinal Products Produced According to Homoeopathic Principles
Ingeborg Allmann1, Anton Biber2, Jürgen Blaha3, Anke Boekhoff4, Ralf Burgert1, Wolfgang Guilliard5, Karl Heinz Scheler6, Eberhard Willing7, Barbara Steinhoff8
1 Biologische Heilmittel Heel GmbH, Baden-Baden (Germany)
2 Deutsche Homöopathie-Union GmbH & Co. KG, Karlsruhe (Germany), European Coalition on Homeopathic and Anthroposophic Medicinal Products (ECHAMP), Brussels (Belgium)
3 Weleda AG Heilmittelbetriebe, Schwäbisch Gmünd (Germany)
4 WALA Heilmittel GmbH, Bad Boll (Germany)
5 Hevert-Arzneimittel GmbH & Co. KG, Nussbaum (Germany)
6 Phönix Laboratorium GmbH, Bondorf (Germany)
7 Pharmazeutische Fabrik Dr. Reckeweg & Co. GmbH, Bensheim (Germany)
8 Bundesverband der Arzneimittel-Hersteller e. V., Bonn (Germany)
Based on the document “Points to Consider on Stability Testing of Homeopathic Medicinal Products” (July 2009) the following contribution intends to elucidate the regulatory requirements for stability testing and the implementation in daily practice of pharmaceutical companies manufacturing homoeopathic and anthroposophic medicinal products. Stability testing has to be performed where necessary and scientifically justified, but should be restricted to an appropriate extent due to the specific characteristics of these products.
Key words Anthroposophic medicinal products • Homeopathic Medicinal Products Working Group (HMPWG) • Homoeopathic medicinal products • Most concentrated homoeopathic preparation • Mother tincture • Stability testing |
