Sachgerechte Umsetzung der GACP- und GMP-Anforderungen an die Herstellung pflanzlicher Wirkstoffe
Dr. Norbert Brand1, Thomas Brückner2, Dr Frauke Gaedcke1 und Barbara Steinhoff3
1 für die BAH/BPI-Arbeitsgruppe der Extrakt-Hersteller
Herbal preparations are in principle active substances in the sense of GMP. Due to their natural origin, however, they have some particularities which must be taken into consideration within the requirements for their production and quality, as described in Part II of the EC Guide to GMP. This publication is intended to exemplify how the individual process steps and activities during the production of the herbal preparations „cut herbal drug“ and „powdered herbal drug“ as well as „liquid extract“, „tincture“ and „oily macerate“ are nowadays implemented in an appropriate manner. In this context the combination of GACP and GMP guarantees a complete quality assurance from the field to the herbal medicinal product. For many years already, the manufacturers of herbal preparations proceed according to this concept.
pharmind 2008, Nr. 8, Seite 999