Quality Assurance in Early Process Steps in the Production of Herbal Medicinal Products

Rubrik: GMP / GLP / GCP

(Treffer aus pharmind, Nr. 05, Seite 611 (2022))

Wolf I | Valder C | Waimer F | Wagner B | Dalichow K | Steinhoff B

Quality Assurance in Early Process Steps in the Production of Herbal Medicinal Products / Wolf et al. • Quality Assurance · Wolf I¹, Valder C², Waimer F³, Wagner B⁴, Dalichow K⁵, Steinhoff B⁶ · ¹Bionorica SE, Neumarkt und Systema Natura GmbH, Flintbek und Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe und Finzelberg GmbH & Co. KG, Andernach und Dr. Loges + Co. GmbH, Winsen (Luhe) und Bundesverband der Arzneimittel-Hersteller e. V., Bonn
Herbal medicinal products contain active substances of plant origin such as comminuted (cut or powdered) or whole herbal drugs, dry, soft or liquid extracts, tinctures, expressed juices, oleoresins, gums, exudates or essential oils. Annex 7 of the EU GMP Guideline [ 1 ] sets an overall framework for the entire process chain, starting from Good Agricultural and Collection Practice (GACP) [ 2 ] with its requirements for the agricultural production steps such as cultivation, collection, cutting before drying, drying and primary processing and ending up with Part II and I of the EU GMP Guideline [ 3 ,  4 ] for the ...