Privatsphäre-Einstellungen

On-going Stability Testing of Medicinal Products Produced According to Homoeopathic or Anthroposophic Principles

Anton Biber¹, Anke Boekhoff², Ralf Burgert³, Wolfgang Guilliard⁴, Andreas Kuhn⁵, Eberhard Willing⁶, Barbara Steinhoff⁷

¹ Deutsche Homöopathie-Union GmbH & Co. KG, Karlsruhe
² WALA Heilmittel GmbH, Bad Boll
³ Biologische Heilmittel Heel GmbH, Baden-Baden
⁴ Hevert-Arzneimittel GmbH & Co. KG, Nussbaum
⁵ Weleda AG Heilmittelbetriebe, Schwäbisch Gemünd
⁶ Pharmazeutische Fabrik Dr. Reckeweg & Co. GmbH, Bensheim
⁷ Bundesverband der Arzneimittel-Hersteller e.V. (BAH), Bonn

Chapter 6 of the EU Guidelines to GMP requires the performance of on-going stability studies. They are performed during marketing of the products and include also homoeopathic and anthroposophic medicinal products. Due to the specific characteristics of these products such as the large variety of the products and the mostly small batch sizes, on-going stability testing should be restricted to an appropriate extent. Based on the experiences of the manufacturers gained during the past few years, a pragmatic approach including different testing strategies is proposed for various dosage forms of homoeopathic and anthroposophic medicinal products.