Privatsphäre-Einstellungen

Sachgerechte Umsetzung der GACP- und GMP-Anforderungen an die Herstellung pflanzlicher Wirkstoffe

Teil 1

Dr. Norbert Brand¹, Thomas Brückner², Dr Frauke Gaedcke¹ und Barbara Steinhoff³

¹ für die BAH/BPI-Arbeitsgruppe der Extrakt-Hersteller
² Bundesverband der Pharmazeutischen Industrie e.V. (BPI), Berlin
³ Bundesverband der Arzneimittel-Hersteller e.V. (BAH), Bonn

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.