- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Quality Assurance
(2003; 80 pages) [French] [Spanish]
Within the overall context of quality assurance, the WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants are primarily intended to provide general technical guidance on obtaining medicinal plant materials of good quality for the sustainable production of herbal products classified as medicines. They apply to the cultivation and collection of medicinal plants, including certain post-harvest operations. Raw medicinal plant materials should meet all applicable national and/or regional quality standards. The guidelines therefore may need to be adjusted according to each country's situation.
The main objectives of these guidelines are to:
♦ contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines, which aims to improve the quality, safety and efficacy of finished herbal products;
♦ guide the formulation of national and/or regional GACP guidelines and GACP monographs for medicinal plants and related standard operating procedures; and
♦ encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines should be considered in conjunction with the existing documents and publications relating to the quality assurance of herbal medicines and to the conservation of medicinal plants (for details, see Bibliography below), for example:
- Good Manufacturing Practices for pharmaceutical products: main principles (2)
- Good manufacturing practices: supplementary guidelines for manufacture of herbal medicinal products (3)
- Quality control methods for medicinal plant materials (4)
- Guide to good storage practices for pharmaceuticals (5)
- Good trade and distribution practices (GTDP) for pharmaceutical starting materials (6)
- General guidelines for methodologies on research and evaluation of traditional medicine (7)
- Guidelines for the assessment of herbal medicines (8)
- WHO monographs on selected medicinal plants (9, 10)
- WHO/IUCN/WWF Guidelines on the conservation of medicinal plants (12).
In addition, these guidelines should be seen in the context of the relevant guidelines and codes of practices developed by the Joint FAO/WHO Codex Alimentarius Commission, particularly as medicinal plants may be subject to general requirements for foods under some national and/or regional legislation. Examples of Codex Alimentarius texts that may be applicable to medicinal plants include:
- Codex Alimentarius Code of Practice - General Principles of Food Hygiene (13)
- Codex Alimentarius Guidelines on production, processing, labelling and marketing of organically produced foods (14)
- Codex Alimentarius Code of hygienic practice for spices and dried aromatic plants (15).
The WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants do not provide sufficient guidance for the production of organic herbal medicines, and other national, regional and/or international guidelines should be consulted.