- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Quality Assurance
(2003; 80 pages) [French] [Spanish]
Standard operating procedures should be adopted and documented. All processes and procedures involved in the production of medicinal plant materials and the dates on which they are carried out should be documented. An example of a cultivation record is provided in Annex 5. The types of information that should be collected include:
♦ seeds and other propagation materials
♦ cultivation or collection site
♦ crop rotation at the site
♦ application of fertilizers, growth regulators, pesticides and herbicides
♦ unusual circumstances that may influence the quality (including chemical composition) of the medicinal plant materials (e.g. extreme weather conditions, exposure to hazardous substances and other contaminants, or pest outbreaks)
♦ harvest or collection
♦ all processing
♦ application of fumigation agents.
Multiple sets of good herbarium specimens should be prepared and preserved for confirmation of plant identity and reference use. A photographic record (including film, video, or digital images) of the cultivation or collection site and the medicinal plants under cultivation or collection should be made, whenever possible.
All agreements between the grower or collector, processor and purchaser, and intellectual property and benefit-sharing agreements should be recorded.
Batch numbers should unambiguously and clearly identify all batches from each cultivation or collection area. Assignment of batch numbers should take place at an early stage of production. Collected and cultivated medicinal plant materials should carry different batch numbers.
Where applicable, the results of audits should be documented in an audit report which contains copies of all documents, analysis reports, and local, national and/or regional regulations, and which are stored according to their requirements.