Abstract

ABSTRACT During the past few years, European and national health authorities as well as WHO have published several recommendations regarding good cultivation and wild crafting practices for medicinal plants. Within the quality assurance system of medicine manufacturers, the obligation to evaluate suppliers on a regular basis has become part of these recommendations. For this reason, the German Research Association of Medicine Manufacturers (FAH) has developed a standard operating procedure for audits of cultivation and wild crafting of medicinal plants under which instructions for the implementation and documentation of operating procedures for such audits can be created. Since auditing requirements need to be adopted to the company being audited, this standard operating procedure is a recommendation and not a binding rule.

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