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 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. |
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pharmind 2011, Nr. 3, Seite 494