- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Quality Assurance
(2003; 80 pages) [French] [Spanish]
2.1 This "Points to Consider" document is intended to address the specific concerns of growing, collecting and primary processing of medicinal plants/herbal drugs that are used for medicinal purposes. It addresses specific issues associated with agricultural production and collection of medicinal plants/herbal drugs in the wild. These considerations should be read in connection with GMP guidelines for APIs and should apply to all methods of production including organic production in accordance with regional and/or national regulations. These provide additional standards for the production and processing of medicinal plants/herbal drugs insofar as they mainly focus on identifying those critical production steps that are needed to ensure good quality.
2.2 The main aim is to ensure consumer safety by establishing appropriate quality standards for medicinal plants/herbal drugs. Especially important aspects are that medicinal plants/herbal drugs:
- are produced hygienically, in order to reduce microbiological load to a minimum,
- are handled with care so that medicinal plants/herbal drugs are not adversely affected during collection, cultivation, processing and storage.
During the course of the production process medicinal plants/herbal drugs and their preparations are exposed to a large number of microbiological and other contaminants. This "Points to Consider" provides recommendations for producers to reduce contamination to a minimum.
2.3 These "Points to Consider" are intended for all participants from primary producers to traders and processors. Therefore, producers, traders and processors of medicinal plants/herbal drugs should comply with these considerations, document all relevant activities in batch documentation and demand that their partners do likewise, unless it can be justified otherwise.
Growers and collectors of medicinal plants/herbal drugs must insure that they avoid damage to existing wildlife habitats. CITES (Convention on International Trade in Endangered species of Wild Fauna and Flora) must be adhered to.