Implementation of Sustainability Standards that Contribute to Assurance of Pharmacopoeial Quality of Wild Collected Medicinal Plants

The majority of commercially traded medicinal and aromatic plant species are wild collected as opposed to being produced through controlled cultivation. In order to assure a consistent supply of uniform botanical raw materials of defined pharmacopoeial quality, long-term relationships, planning, technical cooperation and transparency are necessary throughout the supply chain between the wild collection firms, the intermediate buyers and processors, and the end-user finished product manufacturers. Liquiritiae radix PhEur (dried unpeeled or peeled root and stolons of Glycyrrhiza glabra L. and/or of Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch., containing not less than 4.0 per cent of glycyrrhizic acid) [1] is among the most widely used and traded wild-collected medicinal plants in the global market. In 2006, in collaboration with our supplier, we began test implementations of three sustainability standards at our licorice root wild collection site; a) United States Department of Agriculture (USDA) Wild-crop Harvesting Practice Standard [2]; b) International Standard for Sustainable Wild Collection of Medicinal and Aromatic Plants (ISSC-MAP) [3]; and c) FairWild Standard [4]. Our experience to date provides evidence as to how the implementation of these three standards, with independent auditing and reporting, contributes to assuring conformance to the qualitative and quantitative pharmacopoeial standards for composition, identity, quality, purity, and strength, and also facilitate compliance with the production and process control system requirements of Current Good Manufacturing Practice (CGMP) [5]. References: [1] European Pharmacopoeial Commission (2008) European Pharmacopoeia, 6th edition. European Directorate for the Quality of Medicines and Healthcare. Strasbourg, France. [2] United States Department of Agriculture (2008) Wild-crop harvesting practice standard. In: Code of Federal Regulations, Title 7, Vol. 3, Sec. 205.207, p.395. [3] Medicinal Plant Specialist Group (2007) International Standard for Sustainable Wild Collection of Medicinal and Aromatic Plants (ISSC-MAP), Version 1.0. Bundesamt für Naturschutz (BfN), MPSG/SSC/IUCN, WWF Germany, and TRAFFIC, Bonn, Gland, Frankfurt, and Cambridge (BfN-Skripten 195). [4] Meinshausen F, Winkler S, Bächi R, Staubli F (2006) FairWild Standards, Version 1 (11/2006). FairWild Foundation. Weinfelden, Switzerland. [5] United States Food and Drug Administration (2008) Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Subpart E: Requirement to Establish a Production and Process Control System. In: Code of Federal Regulations, Title 21, Vol. 2, Sec. 111.75, p.238–240.