- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Quality Assurance
(2003; 80 pages) [French] [Spanish]
4.2. Bulk packaging and labelling
Processed medicinal plant materials should be packaged as quickly as possible to prevent deterioration of the product and to protect against unnecessary exposure to potential pest attacks and other sources of contamination.
Continuous in-process quality control measures should be implemented to eliminate substandard materials, contaminants and foreign matter prior to and during the final stages of packaging. Processed medicinal plant materials should be packaged in clean, dry boxes, sacks, bags or other containers in accordance with standard operating procedures and national and/or regional regulations of the producer and the end-user countries. Materials used for packaging should be non-polluting, clean, dry and in undamaged condition and should conform to the quality requirements for the medicinal plant materials concerned. Fragile medicinal plant materials should be packaged in rigid containers. Whenever possible, the packaging used should be agreed upon between supplier and buyer.
Reusable packaging material such as jute sacks and mesh bags should be well cleaned (disinfected) and thoroughly dried prior to reuse, so as to avoid contamination by previous contents. All packaging materials should be stored in a clean and dry place that is free from pests and inaccessible to livestock, domestic animals and other sources of contamination.
A label affixed to the packaging should clearly indicate the scientific name of the medicinal plant, the plant part, the place of origin (cultivation or collection site), the cultivation or collection date and the names of the grower/collector and the processor, and quantitative information. The label should also contain information indicating quality approval and comply with other national and/or regional labelling requirements.
The label should bear a number that clearly identifies the production batch. Additional information about the production and quality parameters of the medicinal plant materials may be added in a separate certificate, which is clearly linked to the package carrying the same batch number.
Records should be kept of batch packaging, and should include the product name, place of origin, batch number, weight, assignment number and date. The records should be retained for a period of three years or as required by national and/or regional authorities.