- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Quality Assurance
(2003; 80 pages) [French] [Spanish]
7.1 All processes and procedures that could affect the quality of the product must be documented.
7.2 Extraordinary circumstances during the growth period that may influence the chemical composition of the medicinal plant/herbal drug such as extreme weather conditions and pests, particularly in the harvest period must be documented.
7.3 For cultivated medicinal plants/herbal drugs all processing steps have to be documented including the location of cultivation. Field records showing previous crops and plant protect products used should be maintained by all growers.
7.4 For cultivated medicinal plants/herbal drugs, it is essential to document the type, quantity and the date of harvest as well as the chemicals and other substances used during production such as fertilizers, pesticides, herbicides and growth promoters.
7.5 The application of fumigation agents must be documented.
7.6 The geographic location of the collection area and the harvest period should be described as precise as possible.
7.7 All batches from each designated area should be unambiguously and unmistakably identified by batch number. Assignment of batch number should take place at an early stage. Collected and cultivated medicinal plant/herbal drug material should carry different batch numbers.
7.8 Batches from different geographical areas shall be mixed only if it can be guaranteed that the mixture itself will be homogenous. Such processes should be well documented.
7.9 All agreements (production guidelines, contracts etc.) between producer or collector and buyer should be in written form. It should be documented that cultivation, harvesting and production have been performed in accordance with these agreements. Minimum information included in the documentation should cover geographical location, country of origin and responsible producer.
7.10 The results of audits should be documented in an audit report (copies of all documents, audit reports, analysis reports) to be stored for a minimum of 10 years.