Quality Requirements

For Echinacea end products, there are pharmacopoeia standards or monographs at the national level; for example, in Germany such requirements are found in the Deutsches Arzneibuch (DAB).

In Europe, monographs issued by the European Scientific Cooperation on Phytotherapy (ESCOP) also include E. purpurea radix, E. purpurea herba, and E. pallida radix (ESCOP, 1997). However, there are no general, specific quality requirements for field cultivation. Medicinal companies have their own quality requirements; growers supply raw materials that must comply with them. These companies are mainly concerned with the authenticity of the plants cultivated, microbiological purity, and presence of pesticide residues and heavy metal contents of the raw materials.

Toward ensuring high-quality raw materials and end products for the medicinal industry, a strict compilation of regulations known as Good Manufacture Practice has been accepted in European Union countries. Significant efforts were then focused on the preparation of similar guidelines for field cultivation of medicinal plants as well, to ensure appropriate raw materials from the field (Franz, 1989). The results of efforts until 1989 were compiled by Franz (1989), and the final accepted guidelines of Good Agricultural Practices were published by Mathe and Franz (1999).

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