- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Quality Assurance
(2003; 80 pages) [French] [Spanish]
Annex 1. Good Agricultural Practice for Traditional Chinese Medicinal Materials, People's Republic of China
State Administration of Pharmaceutical Supervision
Good Agricultural Practice for Traditional Chinese Medicinal Materials (Trial Edition), adopted after consideration by the General Committee of the State Administration of Pharmaceutical Supervision on 18 March 2002, is hereby issued and will come into force on 1 June 2002.
17 April 2002
Good Agricultural Practice for Traditional Chinese Medicinal Materials
Chapter I General Provisions
Article 1 The purpose of this document is to standardize the production of traditional Chinese medicinal material, guarantee its quality, and facilitate the standardization and modernization of traditional Chinese medicines.
Article 2 This document elucidates the basic guidelines for the production and quality control of traditional Chinese medicinal material which are applicable to the entire production process of traditional Chinese medicinal material, including both herbs and animal parts for medicinal use, by manufacturers of traditional Chinese medicinal material.
Article 3 Manufacturers should adopt measures for standardized management and quality surveillance, conserve natural medicinal resources and the ecological environment, and follow the principle of "maximizing sustainable output", so as to ensure sustainable use of resources.
Chapter II Ecological Environment of Production Sites
Article 4 Following the principle of optimizing the suitability of production sites for traditional Chinese medicinal material, manufacturers should make the best of existing conditions and rationalize overall arrangements.
Article 5 The environmental conditions of production sites for traditional Chinese medicinal material should conform to relevant national standards:
The atmospheric conditions should meet the B level standard for atmospheric environment quality; the soil should meet the B level standard for soil quality; water for irrigation should meet the quality standard for agricultural irrigation water; and drinking water for animals intended for medicinal use should meet the quality standard of drinking water for human consumption.
Article 6 Farms breeding animals intended for medicinal use should satisfy the needs of animal populations in relation to ecological factors, as well as corresponding conditions for life and reproduction.
Chapter III Seeds and Propagation Material
Article 7 The species, subspecies, variety or type of bred animals, cultivated herbs or those collected from wild life which are intended for medicinal use should be accurately identified with both the Chinese name and the scientific name recorded.
Article 8 A system of inspection and disease control should be enforced for seeds, fungal spores and propagation material during their production, storage and transportation processes, so as to ensure quality and prevent the spread of plant diseases, insect pests and weeds, and to prevent the trading and distribution of substandard seeds, fungal spores and propagation material.
Article 9 The introduction and domestication of animals used for medicinal purposes should be in accordance with the habits of these animals. Care should be taken to protect the animals from physical and sensory injury during trapping and transportation. Stringent epidemic control measures must be carried out for the introduction of animal species, with a specific period of quarantine and observation.
Article 10 Efforts should be made to improve the selection and breeding of fine varieties of traditional Chinese medicinal material by developing designated sites for the production of high quality medicinal material and conserving animal and plant resources used for medicinal purposes.
Chapter IV Management of Cultivation and Animal Husbandry
Section One Management in Cultivation of Medicinal Herbs
Article 11 Appropriate areas for cultivation should be identified and corresponding agricultural practices determined on the basis of the specific requirements for growth and development of medicinal herbs.
Article 12 The type, timing and quantity of fertilization should be determined by the nutritional requirements of medicinal herbs and the supporting capacity of the soil. The type of fertilizer used should be largely organic in nature, while limited use may be made of chemical fertilizer according to the needs of various species of medicinal herbs for their growth and development.
Article 13 It is permissible to use farm manure which has been thoroughly composted to meet harm-free sanitary standards. It is prohibited to use urban household garbage, industrial and hospital wastes or human faeces as fertilizer.
Article 14 Timely and proper irrigation and drainage should be carried out in accordance with the pattern of water requirements for medicinal herbs during different periods of growth and development, as well as with climatic conditions and soil dampness, so as to maintain good soil ventilation.
Article 15 In consideration of the growth and development characteristics of medicinal herbs as well as the different parts to be used, field management should be enhanced by the timely application of cultivation measures, such as topping, nipping buds, pruning and shading, so as to control the growth and development of the plant, increase production and keep the quality at a stable level.
Article 16 Comprehensive prevention and control strategies should be used against diseases and insect pests which affect medicinal herbs. If it is necessary to apply pesticides, the smallest effective dosage should be used and highly effective, low-toxicity and low-residue pesticides should be selected in accordance with the provisions of the Regulations for Pesticide Management in the People's Republic of China, so as to reduce pesticide residue and pollution by heavy metals, and protect the ecological environment.
Section Two Management of Animal Husbandry for Medicinal Purposes
Article 17 Methods and practices of animal husbandry should be identified on the basis of such characteristics as the living environment, food habits and behaviour of animals intended for medicinal purposes and their ability to adapt to the environment, and corresponding animal husbandry regulations and management systems should be determined.
Article 18 Animal feed should be scientifically prepared and given at regular intervals in regular quantities according to the patterns of seasonal and daily activity as well as the different life cycles and physiological characteristics of the animals intended for medicinal purposes. Supplements such as fine feed, vitamins, minerals and other essential additives should be given at appropriates times and in appropriate quantities, but no additives containing hormones or hormone-like substances should be given. The feed and additives should not cause pollution.
Article 19 In animal husbandry for medicinal purposes, the timing and frequency of water supply should be determined with conditions such as the season, air temperature and ventilation in mind. Herbivores should, as far as possible, meet their needs for water through eating large quantities of green and juicy fodder.
Article 20 Fixed structures with adequate space and necessary safety facilities should be set up in accordance with the resting habits, behaviour and other characteristics of animals intended for medicinal purposes.
Article 21 Animals should be raised in a clean environment. A disinfection system should be established, and appropriate disinfectants should be selected for regular disinfection of sites and equipment used in animal husbandry. Management of personnel with access to such sites should be strengthened.
Article 22 Disease control in animals intended for medicinal purposes should mainly rely on prevention, including vaccination at regular intervals.
Article 23 Animal husbandry quarters should be rationally designed with consideration given to appropriate population density in the case of gregarious animals. If sick animals are found, they should be promptly put into quarantine. Animals suffering from infectious diseases should be immediately put to death and incinerated or deeply buried.
Article 24 The composition and structure of animal populations should be determined in accordance with animal husbandry plans and breeding needs, and turnovers should be made at appropriate intervals.
Article 25 It is prohibited to produce traditional Chinese medicinal materials from intoxicated or diseased animals intended for medicinal purposes.
Chapter V Harvesting and Primary Processing
Article 26 The principle of "maximizing sustainable output" should be adhered to in the collection of wild or semi-wild medicinal herbs, with planned cultivation of wild herbs, collection rotation and periods of protected growth, so as to facilitate biological propagation and resource renewal.
Article 27 The appropriate harvesting time (including harvesting seasons and years) and methods should be identified in accordance with the quality of the product and the yield of the plants per unit area or number of animals raised, and with consideration of factors such as conventional harvesting practices.
Article 28 Machinery and instruments used for harvesting should be clean, free of contamination and kept in a dry place free of insects, rodents and livestock.
Article 29 During harvesting and primary processing, efforts should be made, as far as possible, to remove non-medicinal parts and foreign objects, in particular weeds and toxic substances, and to discard damaged or rotten parts.
Article 30 After harvesting, the medicinal parts should be subject to appropriate processing, such as selection, washing, cutting, or trimming. When drying is required, they should be promptly dried by way of appropriate measures and techniques. The temperature and humidity should be controlled to avoid pollution of the medicinal material or damage to active ingredients.
Article 31 Fresh products may be stored by refrigeration, in sand, in jars, by biological conservation and other appropriate conservation methods. The use of conservatives and preservatives should be avoided to the extent possible, and, if their use is requisite, it should conform to relevant national regulations on food additives.
Article 32 Processing sites should be clean, well ventilated, and have the facilities for protection against sunlight, rain, rodents, insects and livestock.
Article 33 Conventional methods should be used for processing genuine medicinal material. If modifications are made, adequate testing data should be provided and the quality of the medicinal material should not be affected.
Chapter VI Packaging, Transportation and Storage
Article 34 Inspection is necessary before packaging to eliminate substandard products and foreign objects. Packaging should be done in accordance with standard operational regulations and records should be kept of batch packaging, including the product name, specifications, origin, batch number, weight, packaging assignment number and packaging date.
Article 35 The material used for packaging should be clean, dry, non-polluted, undamaged and in conformity with the quality requirements for the medicinal material.
Article 36 The product name, specifications, origin, batch number, packaging date and manufacturer should be indicated on each package of medicinal material, and there should also be a label indicating quality approval.
Article 37 Fragile medicinal material should be packaged in strong boxes; toxic, narcotic and valuable medicinal material should be specially packaged with corresponding labels.
Article 38 In the case of bulk transport, medicinal material should not be placed in the vicinity of toxic or noxious substances or those which may affect the taste or smell of the material. Transport containers should be relatively well aerated to maintain dryness, and there should be means of protection against humidity.
Article 39 Storage facilities for medicinal material should be well aerated, dry and protected from light, and, when necessary, be supplied with air-conditioning and humidity control equipment as well as facilities to protect against rodents, insects and livestock. The floor should be tidy, without cracks and easy to clean.
Medicinal material should be stored on shelves which keep the material a sufficient distance from the walls; measures should be taken to prevent the occurrence of pest infestation, mould formation, rotting or loss of oil; and inspections should be carried out at regular intervals.
While using conventional methods of storage, attention should be given at the same time to the selective use of modern and novel storage technology and new equipment.
Chapter VII Quality Control
Article 40 Quality control departments should be set up by manufacturers to oversee the supervisory management and quality control of the entire production process of traditional Chinese medicinal material, and should be supplied with staff, sites, instruments and equipment corresponding to the scale of production and the inspection requirements for the products.
Article 41 The principal functions of the quality control department are:
1. Environmental surveillance and hygiene control;
2. Inspecting production resources, packaging material and medicinal material, and issuing inspection reports;
3. Developing training programmes and supervising their implementation;
4. Preparing and managing quality control documentation, and managing all kinds of original records concerning production, packaging and inspection, etc.
Article 42 Before packaging, an inspection should be made of each batch of medicinal material by the quality control department on the basis of national standards for traditional Chinese medicinal material or standards reviewed and approved by the authorities. The extent of the inspection should at least include the properties and identification of the medicinal material, foreign matter, moisture content, ash content and content of ash insoluble in acids, seepage, marker substances or content of active ingredients. Restrictions on the content of pesticide residue, heavy metals and microorganisms should be in line with national standards and relevant regulations.
Article 43 Inspection reports should be signed by personnel who carried out the inspection and persons in charge of the quality control department. Such inspection reports should be placed on file.
Article 44 Sub-standard traditional Chinese medicinal material is not to be distributed and sold.
Chapter VIII Personnel and Equipment
Article 45 Persons in charge of technological matters at production sites for medicinal material should have received at least two years of higher education in pharmacy or agronomy, animal husbandry or other relevant fields, and should have practical experience in the production of medicinal material.
Article 46 Persons in charge of quality control departments should have completed at least two years of higher education, and should have experience in the quality control of medicinal material.
Article 47 All personnel involved in the production of traditional Chinese medicinal material should have a basic understanding of Chinese pharmacy, agronomy or animal husbandry, and should have received training in production techniques, safety and hygiene. Personnel working in the fields should have good knowledge of cultivation techniques, particularly the use of pesticides and protection techniques; personnel involved in animal husbandry should have a good understanding of animal husbandry techniques.
Article 48 Personnel involved in processing, packaging and inspection should receive medical check-ups at regular intervals. Persons suffering from infectious diseases, skin disease or open wounds should not be allowed to perform functions which involve direct contact with medicinal material. Specific persons should be designated by the manufacturer to be responsible for inspecting environmental sanitation and personnel hygiene.
Article 49 Relevant personnel involved in the production of traditional Chinese medicinal material should receive training and be examined at regular intervals.
Article 50 Production sites for traditional Chinese medicinal material should be furnished with toilets or washrooms, and excreta should not lead to pollution of the environment and the products.
Article 51 The extent of application and precision of instruments, meters, measuring tools and weighing equipment used in production and inspection at production sites should be in line with the requirements for production and inspection. Such equipment should carry clearly marked labels indicating their status, and be regularly calibrated.
Chapter IX Documentation
Article 52 Manufacturers should have standard operational regulations for production management and quality control.
Article 53 There should be detailed records kept of the entire production process for each kind of traditional Chinese medicinal material, with photographs or pictures when necessary. The records should include:
1. The origin of seeds, fungal spores and propagation material;
2. Production techniques and processes:
(1) The planting time, quantity and area of medicinal herbs; the growth of seedlings, transplantation, the kind of fertilizer used, and the time, amount and method of its use; the type of pesticide used - including insecticides, fungicides and herbicides - and the amount, time and method of its use.
(2) In the case of animals intended for medicinal purposes, daily records of animal husbandry, turnover plans, records of selection and breeding, records of births and the production of eggs, records of diseased cases, death reports, death registration forms, statistical forms for disease control and vaccination, feed preparation forms, feed consumption records, pedigree registration forms, offspring identification forms, etc.;
(3) The time of collection, collected amount, fresh weight, processing, drying, reduced weight after drying, transportation, and storage of medicinal parts;
(4) Meteorological data and micro-climatic records;
(5) Evaluation of the quality of the medicinal material: records of the properties and inspection results of the medicinal material.
Article 54 All original records, production plans and records of their implementation, contracts and written agreements should be put on file and kept for at least 5 years. Files and archives should be maintained by designated persons.
Chapter X Supplementary Articles
Article 55 Glossary:
(1) Traditional Chinese medicinal material refers to raw medicinal material produced by primary processing at the place of origin after collecting the medicinal parts of plants and animals intended for medicinal purposes.
(2) Manufacturers of traditional Chinese medicinal material refer to enterprises of a certain scale which follow certain procedures in the production process, such as the cultivation of medicinal herbs or animal husbandry, primary processing, packaging and storage of medicinal material.
(3) Maximizing sustainable output refers to the maximum output of sustainable production (collection) with no harm caused to the ecological environment.
(4) Genuine medicinal material refers to traditional Chinese medicinal material with specific properties, originating from specific locations or produced through specific production techniques and processing methods.
(5) Seeds, fungal spores and propagation material refer to parts, tissues and cells of plants as well as hyphae and fungal seeds which can be used for propagation; and breeding stock, young animals and eggs.
(6) Comprehensive prevention and control of diseases and insect pests refers to keeping the harm caused by diseases and insect pests below the economic threshold by appropriately implementing biological, agricultural and chemical methods as well as other effective ecological measures that are safe, efficient, affordable, easy to use, and suitable for local conditions with an overall view of biological and environmental circumstances and based on the principle of giving priority to prevention, so as to achieve the aim of improving economic efficiency and increasing ecological benefits.
(7) Semi-wild animals and plants intended for medicinal purposes refer to wild animals and plants intended for medicinal purposes or those which have reverted to wild life, but which have been subject to appropriate human care and management, such as intertilling, weeding, fertilization or feeding.
Article 56 The power of interpreting this present document lies with the State Administration of Pharmaceutical Supervision.
Article 57 The provisions of this document shall come into force on 1 June 2002.