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Laws & Regulations - Drugs - Good Agricultural Practice for Chinese Crude Drugs (Interim)
Good Agricultural Practice for Chinese Crude Drugs (Interim)
 
2011/7/13 9:29:21¡¡Source: ¡¡Hits:

(Order No. 32 of SDA)
The Good Agricultural Practice for Chinese Crude Drugs (Interim) was passed by the State Drug Administration at the administration affairs meeting on March 18 of 2002, is hereby promulgated and shall go into effect as of June 1, 2002.
April 17, 2002

Good Agricultural Practice for Chinese Crude Drugs (Interim)
Chapter I General Provisions
Article 1 The Good Agricultural Practice (GAP) for Chinese Crude Drugs is formulated to regulate the production of Chinese crude drugs, ensure their quality and facilitate the standardization and modernization of traditional Chinese medicines.
Article 2 This GAP provides the basic principles for the production and quality management of Chinese crude drugs and is applicable to producers of Chinese crude drugs (hereinafter referred to as producers) for the entire production process of Chinese crude drugs (from plant or animal origin).
Article 3 Producers should adopt standardized management and quality control to protect resources of natural crude drugs and the ecological environment, and realize sustainable utilization based on the principle of ¡°maximum sustainable yield¡±.
Chapter II Ecological Environment of Production Site
Article 4 Producers should rationally select their production sites for Chinese crude drugs according to the principle of optimization and local conditions.
Article 5 The environment condition of production sites for Chinese crude drugs should meet the requirements of the related national standards:
¡°Atmospheric Conditions Standard¡±, Grade 2 for air quality;
¡°Soil Quality Standard¡±, Grade 2 for soil;
¡°Farm Irrigation Water Standard¡±, Grade 2 for irrigation;
¡°Drinking Water Standard¡± for animal drinking water.
Article 6 Medicinal animal rearing sites should meet the requirements for the ecological environment of the animal population, and appropriate conditions of the animal¡¯s habitat and reproduction.
Chapter III Germ-plasma and Propagation Material
Article 7 Species, subspecies, varieties or cultivars of medicinal plants and animals reared, cultivated or existing in the wild should be clearly identified and recorded in the Chinese adopted name and Latin name.
Article 8 Testing and quarantining procedures should be carried out in the process of production, storage and transportation of seeds, strains and propagation material to ensure their quality, prevent the spread of diseases, pests and weeds, as well as the trade in, and spread of, counterfeit and substandard seeds, strains and propagation materials.
Article 9 The introduction and domestication of animal breeds should be based on their habits. Physical and/or mental injuries to the animals should be avoided in the process of capture and transportation. Introduced breeds should be strictly quarantined, and observed for a specified period of time.
Article 10 The selection or breeding of fine varieties or breeds should be enhanced, their propagation bases should be established, and germ-pl

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