Model implementation of the legal regulation on medicinal plant cultivation for pharmaceutical purposes. Case study of Crocus sativus cultivation in Ukraine

Crocus sativus L. (Iridaceae) is the source of saffron, a traditional spice and herbal medicine, usually cultivated in Southwest Asia and the Mediterranean. Saffron is a new niche food and medicinal plant in Ukraine. An important area of production, namely the application of Good Agricultural and Collection Practice (GACP) principles for obtaining high-quality saffron raw materials for the pharmaceutical industry, has been evaluated. The study was conducted on a plantation in Lyubimovka village, Kherson Region in Ukraine, from 2016 to 2021. The research object was Crocus sativus and the quality management system in the cultivation and harvesting of medicinal plants. The Ukrainian legislation on herbal drug production introduced guidelines by the World Health Organization (WHO) ‘Good Agricultural and Collection Practice (GACP) for Starting Materials of Herbal Origin’ in 2012. The Guidelines are recommendatory and not mandatory. However, these principles ensure that appropriate quality herbal raw materials are obtained. Implementing GACP principles with the example of saffron includes a description of the plant, sowing material, primary processing, sowing conditions, transportation and storage, packaging, quality control, and documentation. The presented results reflect the entire production process and show the prospects for obtaining high-quality raw materials. The study suggests the results of implementing the WHO GACP guidelines to guarantee the traceability of herbal raw materials and their reliable quality.