Manufacture of homoeopathic preparations: Quality standards for raw materials and applicability of GMP requirements for the manufacture of homoeopathic preparations (Article)

Pharmazeutische Industrie

Volume 76, Issue 3, March 2014, Pages 388-394

Lipinski, A.^a, 

Beck-Dreschel, A.^b, 

Wehausen, R.^c, 

Hering, J.^d, 

Orth, H.^e, 

Striebel, P.^f, 

Steinhoff, B.^g 

 

^a  Homöopathisches Laboratorium A. Pflüger GmbH and Co. KG, Rheda-Wiedenbrück, Germany
^b  Hevert-Arzneimittel GmbH and Co. KG, Nussbaum, Germany
^c  Wala Heilmittel GmbH, Bad Boll, Germany

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Abstract

Homoeopathic medicinal products contain as active substances preparations produced from raw materials of natural and synthetic origin. Besides the general rules of the European Pharmacopoeia and e.g. the German Homoeopathic Pharmacopoeia (HAB), the manufacture of homoeopathic medicinal products is covered by the scope of Part I and Part II of the EU Good Manufacturing Practice (GMP) Guideline. For the production of intermediate stages of the homoeopathic processing steps the manufacturer determines at which step or for which intermediate the scope of GMP starts, depending on the individual preparation and the intended purpose. At the earliest, the scope of GMP starts with the first homoeopathic manufacturing step, i.e. the manufacture of the most concentrated homoeopathic preparation, in most cases followed by subsequent potentization steps until the final grade of dilution is reached. For the steps prior to the first homoeopathic manufacturing step, i.e. the production of starting material for homoeopathic preparations, GMP rules do not apply. The quality of these starting materials is in line with appropriate standards and in accordance with the legal requirements as can be shown for the different groups of raw materials. In Germany, this approach has been implemented by the German Ordinance on the Manufacture of Medicinal Products and Active Substances (AMWHV) which exempts the production of such starting materials for homoeopathic preparations from the scope of GMP and consequently from Part II of the EU GMP Guideline.

Indexed keywords

EMTREE drug terms: chemical compound; homeopathic agent; mineral

EMTREE medical terms: article; dilution; drug manufacture; drug quality; Germany; good manufacturing practice; human; medicinal plant; nonhuman; practice guideline

ISSN: 0031711X CODEN: PHINASource Type: Journal Original language: English

Document Type: Article

Publisher: Editio Cantor Verlag GmbH