Volume 76, Issue 3, March 2014, Pages 388-394
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
b Hevert-Arzneimittel GmbH and Co. KG, Nussbaum, Germany
c Wala Heilmittel GmbH, Bad Boll, Germany
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