- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Quality Assurance
(2003; 80 pages) [French] [Spanish]
Annex 3. Good Agricultural and Collection Practices for Medicinal Plants (GACP), Japan
(Original in Japanese; Unofficial translation of an abridged version)
0.1 Good agricultural and collection practices for medicinal plants (GACP) is a technical guideline on the production of medicinal plant materials as starting materials for crude drugs, finished crude drugs and Kampo medicines, and deal with the following areas:
- Cultivation and collection of medicinal plants and production of medicinal plant materials;
- Post-harvest processing required for medicinal plant materials;
- Quality control of medicinal plant materials.
The GACP is based on Guidelines on cultivation and quality control of medicinal plants, volumes 1-10 (17), whose development were supported by a research grant provided by the Ministry of Health, Labour and Welfare of Japan, with reference to Japanese national quality standards such as The Japanese Pharmacopoeia and Japanese Standards for Herbal Medicines..
0.2 If produced in compliance with this guideline, the medicinal plant materials shall:
- be a high quality product;
- be produced and stored according to good practice and hygiene standards, such that the microbiological load is below the minimum contamination level;
- be produced and stored according to good practice and hygiene standards, such that they should be either free from pesticide residues and other foreign matter or below the minimum level of contamination by pesticide residues and other foreign matter.
0.3 With regard to the minimum level of contamination by microbiological organisms, pesticide residues and other foreign matter, the general principles given in The Japanese Pharmacopoeia should be followed. The actual producer of medicinal plant materials should understand the general principles and should bear in mind the issues associated with the cultivation of medicinal plants as well as post-harvest processing of medicinal plants.
0.4 If medicinal plant materials are produced in compliance with this guideline, they should be described as "products produced in compliance with the guideline" for the information of the general public.
0.5 This guideline should be widely disseminated both nationwide and worldwide in order to promote understanding of the importance of the issues involved.
1.1 In the production processes, including cultivation and collection of medicinal plants and post-harvest processing of the medicinal plant parts, undergone by the raw materials for use in the production of Kampo medicines and crude drug products, the raw materials should be kept as free as possible from microbial and other contaminants and residues such as pesticides.
1.2 In order to produce high quality raw materials, the following procedures should be considered:
- Materials should be well washed in case of possible contaminants;
- The skin of the material should be peeled and the materials should be dried at low temperature in order to avoid any change in the colour and odour of materials, where necessary and appropriate.
1.3 The guideline serve as the standard for the level of microbial contamination in the production of raw materials for crude drugs.
2.1 Medicinal plants should not be cultivated in areas where the land and/or the soil is in a hazardous condition. By hazardous condition of land and/or soil is meant those that are at high risk of contamination by hazardous substances, including heavy metals, agricultural chemical agents, and other industrial waste.
2.2 The preferred soil conditions for the cultivation of medicinal plants are well drained and well irrigated soils.
2.3 Water for irrigation should not be contaminated by domestic animals and human materials.
2.4 Organic compost: the land should be manured with well fermented organic compost either prior to planting or immediately after the first harvest.
2.5 Cows should be prohibited from entering cultivation sites.
2.6 Contaminated water should not be used at the time of harvest.
2.7 Medicinal plants should be planted in an area of land where weeds can grow. Weeds could be an indicator of good cultivation conditions.
2.8 Pesticides and herbicides should be handled only by experienced personnel. The spraying of these chemical agents should be carried out by trained personnel, prior to the harvest at an appropriate interval, and with consideration of the effective duration of the agent used.
3.1 Crop harvesting should not be carried out in wet conditions (dew or rain) or in conditions of high humidity. Whenever possible, harvesting should be carried out in dry, low humidity conditions.
3.2 Harvesting equipment should be clean and well maintained.
3.3 Where mechanical cutters/harvesters are used, the machine parts in contact with the crop, together with their housing, should be cleaned regularly and kept free from accumulated plant material and other debris.
3.4 Cutter blades should be adjusted to avoid soil pick-up.
3.5 All containers used for primary collection of the crop must be kept free from previously accumulated plant material, and when not in use they must be kept in a dry place free from vermin and inaccessible to farm and domestic animals.
3.6 Damaged and spoiled crop material should be sorted and discarded.
3.7 Harvested material should be collected in dry sacks, baskets, trailers or hoppers. It must not be collected on the ground.
3.8 Mechanical damage, high compaction and storage which promotes composting should be avoided:
- plastic sacks should not be used during harvesting;
- sacks must not be overfilled;
- stacking should avoid compaction.
3.9 The time between harvest and transport of crop to the drying site should be kept as short as reasonably practicable.
3.10 The harvested crop should be protected from pests and farm and domestic animals.
4.1 The crop should be unpacked as soon as possible on arrival at the drying facilities. It must not be allowed to stand for extended periods in direct sunlight and must be protected from rain.
4.2 Buildings used for drying crops should be well ventilated and never used for livestock.
4.3 The building should be constructed so as to protect the crop from birds, insects, farm and domestic animals.
4.4 Drying racks should be kept clean and regularly maintained.
4.5 Crops should be placed in thin layers, on wire mesh racks standing off the floor to allow free air circulation, and stirred intermittently to ensure uniform drying and prevent composting.
4.6 Drying on the floor and in direct sunlight is not recommended.
4.7 Dried crops should be inspected and sieved or winnowed to remove discoloured, mouldy and damaged material and soil, stones and other foreign matter. Sieves should be kept clean and maintained regularly.
4.8 Clearly marked waste bins should be provided, emptied daily and cleaned.
4.9 Dried and drying crops should be protected from pests and farm and domestic animals.
4.10 Dried crops should be packed as soon as possible for protection and to lessen the opportunity of pest infestation.
5.1 After removal of damaged material and foreign matter, the sound dried crop should be packed in clean, dry sacks, bags or boxes, preferably new.
5.2 Packing materials should be stored in a clean dry place free from pests and inaccessible to animals.
5.3 Reusable packaging materials such as jute sacks, plastic bags, etc., should be well cleaned and dried before re-use.
5.4 The packed crop should be stored in a dry place away from the wall and off the ground and be protected from pests and farm and domestic animals.
5.5 Whenever possible, the packaging materials used should be agreed between the supplier and the buyer.
6. Storage and Transport
6.1 Packed dried crop should be store in a dry, well ventilated building, with minimal variation in diurnal temperature and with good air ventilation.
6.2 Shutter and door openings should be protected by wire screens to keep out pests and farm and domestic animals.
6.3 It is recommended that packed dried crops should be stored:
- in a building with concrete floors;
- on pallets;
- away from the wall;
- well separated from all other crops.
6.4 For bulk deliveries, the use of vented containers for transport and storage in temporary warehousing is highly recommended to minimize contamination risks. Alternatively, suitable vented transport vehicles and temporary storage facilities are recommended.
6.5 Whenever possible, the conditions for transport and temporary storage should be agreed between supplier and buyer.
6.6 Fumigation to control pests should be applied only where necessary; trained personnel should carry out fumigation. Only approved fumigants should be applied (see also 9.2).
6.7 Chemicals used as pesticides, fumigants, etc., should be kept in a separate area.
7.1 Equipment used for the production and handling of crops should be easily cleaned to minimize contamination. Dry cleaning is recommended. Where the use of water is unavoidable, equipment should be dried as quickly as possible.
7.2 All equipment should be installed to allow easy access and should be well maintained and cleaned regularly.
7.3 The use of wood should be avoided wherever possible.
7.4 Wooden equipment (e.g., pallets, hoppers etc.), if used, should not have chemical treatments, such as chemical fungicides, which could be the source of taint, e.g., chlorophenols.
8.1 Personnel handling medicinal plant material should:
- maintain a high degree of personal hygiene;
- be provided with suitable changing facilities and toilets with hand washing facilities.
8.2 Personnel should not be permitted to work in the herbal material handling area if they are known to be suffering from, or to be carriers of, a disease likely to be transmitted through medicinal plant materials, including diarrhoea.
8.3 Personnel with open wounds, sores, and skin infections should be transferred away from herbal materials handling areas until completely recovered.
9.1 Keeping records of fertilizer, pesticide and herbicide used on each batch of harvested material is highly desirable.
9.2 The use of methylbromide or phosphine for fumigation of herbal materials should be:
- notified to the buyer;
- recorded in shipment papers.
10. Training and Education
10.1 Training and education of personnel, whether handling crops or managing crop production, in appropriate production techniques is highly recommended. This can be achieved by using experts from local agricultural institutes or those provided by the buyers.
11. Quality Control
11.1 Compliance with the recommendations of the GACP should be checked through regular inspection visits by the producer's and the buyer's representatives with expertise in good agricultural and hygiene practice.
11.2 Specifications for herbal materials should be agreed between the producer and the buyer; these may include, for example, active principles and characteristic constituents, microbial load, visual and sensory properties, pesticide residues and heavy metals.