Qualification of Suppliers of Cultivated and Wild Collected Medicinal Plants
GMP / GLP / GCP
Abstract
The qualification of suppliers is part of the quality assurance system of manufacturers of medicinal products. Qualification of suppliers can be fulfilled by different tools, which may be chosen according to the particularities of the material, its use and its supply chain. Such tools, e. g. information from suppliers, on-site visits and ongoing supervision, serve to evaluate cultivation, collecting and primary processing practices in accordance with the Guidelines on Good Agricultural and Collection Practices (GACP) that are part of the European legal framework for the production of medicinal products of herbal origin. In order to assist companies and their suppliers of raw materials, the German Research Association of Medicines Manufacturers (FAH) provides a contribution for the qualification of suppliers with respect to cultivation and collection of medicinal plants and with a focus on the assessment of specific risks in this non-industrial environment. Since such requirements have to be adapted to the needs of the respective company and the supplier, this document is a recommendation and not a binding rule.
Abstract
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