中药材生产质量管理规范（试行） Good Agricultural Practice fo

中药材生产质量管理规范（试行）

第一章　总则

第一条　为规范中药材生产，保证中药材质量，促进中药标准化、现代化，制订本规范。

第二条　本规范是中药材生产和质量管理的基本准则，适用于中药材生产企业（以下简称生产企业） 生产中药材（含植物、动物药）的全过程。

第三条　生产企业应运用规范化管理和质量监控手段，保护野生药材资源和生态环境，坚持"最大持续产量"原则，实现资源的可持续利用。

第二章　产地生态环境

第四条　生产企业应按中药材产地适宜性优化原则，因地制宜，合理布局。

第五条　中药材产地的环境应符合国家相应标准：空气应符合大气环境质量二级标准；土壤应符合土壤质量二级标准；灌溉水应符合农田灌溉水质量标准；药用动物饮用水应符合生活饮用水质量标准。

第六条　药用动物养殖企业应满足动物种群对生态因子的需求及与生活、繁殖等相适应的条件。

第三章　种质和繁殖材料

第七条　对养殖、栽培或野生采集的药用动植物，应准确鉴定其物种，包括亚种、变种或品种，记录其中文名及学名。

第八条　种子、菌种和繁殖材料在生产、储运过程中应实行检验和检疫制度以保证质量和防止病虫害及杂草的传播；防止伪劣种子、菌种和繁殖材料的交易与传播。

第九条　应按动物习性进行药用动物的引种及驯化。捕捉和运输时应避免动物机体和精神损伤。引种动物必须严格检疫，并进行一定时间的隔离、观察。

第十条　加强中药材良种选育、配种工作，建立良种繁育基地，保护药用动植物种质资源。

第四章　栽培与养殖管理

第一节　药用植物栽培管理

第十一条　根据药用植物生长发育要求，确定栽培适宜区域，并制定相应的种植规程。

第十二条　根据药用植物的营养特点及土壤的供肥能力，确定施肥种类、时间和数量，施用肥料的种类以有机肥为主，根据不同药用植物物种生长发育的需要有限度地使用化学肥料。

第十三条　允许施用经充分腐熟达到无害化卫生标准的农家肥。禁止施用城市生活垃圾、工业垃圾及医院垃圾和粪便。

第十四条　根据药用植物不同生长发育时期的需水规律及气候条件、土壤水分状况，适时、合理灌溉和排水，保持土壤的良好通气条件。

第十五条　根据药用植物生长发育特性和不同的药用部位，加强田间管理，及时采取打顶、摘蕾、整枝修剪、覆盖遮荫等栽培措施，调控植株生长发育，提高药材产量，保持质量稳定。

第十六条　药用植物病虫害的防治应采取综合防治策略。如必须施用农药时，应按照《中华人民共和国农药管理条例》的规定，采用最小有效剂量并选用高效、低毒、低残留农药，以降低农药残留和重金属污染，保护生态环境。

第二节　药用动物养殖管理

第十七条　根据药用动物生存环境、食性、行为特点及对环境的适应能力等，确定相应的养殖方式和方法，制定相应的养殖规程和管理制度。

第十八条　根据药用动物的季节活动、昼夜活动规律及不同生长周期和生理特点，科学配制饲料，定时定量投喂。适时适量地补充精料、维生素、矿物质及其它必要的添加剂，不得添加激素、类激素等添加剂。饲料及添加剂应无污染。

第十九条　药用动物养殖应视季节、气温、通气等情况，确定给水的时间及次数。草食动物应尽可能通过多食青绿多汁的饲料补充水分。

第二十条　根据药用动物栖息、行为等特性，建造具有一定空间的固定场所及必要的安全设施。

第二十一条　养殖环境应保持清洁卫生，建立消毒制度，并选用适当消毒剂对动物的生活场所、设备等进行定期消毒。加强对进入养殖场所人员的管理。

第二十二条　药用动物的疫病防治，应以预防为主，定期接种疫苗。

第二十三条　合理划分养殖区，对群饲药用动物要有适当密度。发现患病动物，应及时隔离。传染病患动物应处死，火化或深埋。

第二十四条　根据养殖计划和育种需要，确定动物群的组成与结构，适时周转。

第二十五条　禁止将中毒、感染疫病的药用动物加工成中药材。

第五章　采收与初加工

第二十六条　野生或半野生药用动植物的采集应坚持"最大持续产量"原则，应有计划地进行野生抚育、轮采与封育，以利生物的繁衍与资源的更新。

第二十七条　根据产品质量及植物单位面积产量或动物养殖数量，并参考传统采收经验等因素确定适宜的采收时间（包括采收期、采收年限）和方法。

第二十八条　采收机械、器具应保持清洁、无污染，存放在无虫鼠害和禽畜的干燥场所。

第二十九条　采收及初加工过程中应尽可能排除非药用部分及异物，特别是杂草及有毒物质，剔除破损、腐烂变质的部分。

第三十条　药用部分采收后，经过拣选、清洗、切制或修整等适宜的加工，需干燥的应采用适宜的方法和技术迅速干燥，并控制温度和湿度，使中药材不受污染，有效成分不被破坏。

第三十一条　鲜用药材可采用冷藏、砂藏、罐贮、生物保鲜等适宜的保鲜方法，尽可能不使用保鲜剂和防腐剂。如必须使用时，应符合国家对食品添加剂的有关规定。

第三十二条　加工场地应清洁、通风，具有遮阳、防雨和防鼠、虫及禽畜的设施。

第三十三条　地道药材应按传统方法进行加工。如有改动，应提供充分试验数据，不得影响药材质量。

第六章　包装、运输与贮藏

第三十四条　包装前应检查并清除劣质品及异物。包装应按标准操作规程操作，并有批包装记录，其内容应包括品名、规格、产地、批号、重量、包装工号、包装日期等。

第三十五条　所使用的包装材料应是清洁、干燥、无污染、无破损，并符合药材质量要求。

第三十六条　在每件药材包装上，应注明品名、规格、产地、批号、包装日期、生产单位，并附有质量合格的标志。

第三十七条　易破碎的药材应使用坚固的箱盒包装；毒性、麻醉性、贵细药材应使用特殊包装，并应贴上相应的标记。

第三十八条　药材批量运输时，不应与其它有毒、有害、易串味物质混装。运载容器应具有较好的通气性，以保持干燥，并应有防潮措施。

第三十九条　药材仓库应通风、干燥、避光，必要时安装空调及除湿设备，并具有防鼠、虫、禽畜的措施。地面应整洁、无缝隙、易清洁。

药材应存放在货架上，与墙壁保持足够距离，防止虫蛀、霉变、腐烂、泛油等现象发生，并定期检查。

在应用传统贮藏方法的同时，应注意选用现代贮藏保管新技术、新设备。

第七章　质量管理

第四十条　生产企业应设质量管理部门，负责中药材生产全过程的监督管理和质量监控，并应配备与药材生产规模、品种检验要求相适应的人员、场所、仪器和设备。

第四十一条　质量管理部门的主要职责：（一）负责环境监测、卫生管理；（二）负责生产资料、包装材料及药材的检验，并出具检验报告；（三）负责制订培训计划，并监督实施；（四）负责制订和管理质量文件，并对生产、包装、检验等各种原始记录进行管理。

第四十二条　药材包装前，质量检验部门应对每批药材，按中药材国家标准或经审核批准的中药材标准进行检验。检验项目应至少包括药材性状与鉴别、杂质、水分、灰分与酸不溶性灰分、浸出物、指标性成分或有效成分含量。农药残留量、重金属及微生物限度均应符合国家标准和有关规定。

第四十三条　检验报告应由检验人员、质量检验部门负责人签章。检验报告应存档。

第四十四条　不合格的中药材不得出场和销售。

第八章　人员和设备

第四十五条　生产企业的技术负责人应有药学或农学、畜牧学等相关专业的大专以上学历，并有药材生产实践经验。

第四十六条　质量管理部门负责人应有大专以上学历，并有药材质量管理经验。

第四十七条　从事中药材生产的人员均应具有基本的中药学、农学或畜牧学常识，并经生产技术、安全及卫生学知识培训。从事田间工作的人员应熟悉栽培技术，特别是农药的施用及防护技术；从事养殖的人员应熟悉养殖技术。

第四十八条　从事加工、包装、检验人员应定期进行健康检查，患有传染病、皮肤病或外伤性疾病等不得从事直接接触药材的工作。生产企业应配备专人负责环境卫生及个人卫生检查。

第四十九条　对从事中药材生产的有关人员应定期培训与考核。

第五十条　中药材产地应设厕所或盥洗室，排出物不应对环境及产品造成污染。

第五十一条　生产企业生产和检验用的仪器、仪表、量具、衡器等其适用范围和精密度应符合生产和检验的要求，有明显的状态标志，并定期校验。

第九章　文件管理

第五十二条　生产企业应有生产管理、质量管理等标准操作规程。

第五十三条　每种中药材的生产全过程均应详细记录，必要时可附照片或图象。记录应包括：（一）种子、菌种和繁殖材料的来源；（二）生产技术与过程：

1．药用植物播种的时间、数量及面积；育苗、移栽以及肥料的种类、施用时间、施用量、施用方法；农药中包括杀虫剂、杀菌剂及除莠剂的种类、施用量、施用时间和方法等。

2．药用动物养殖日志、周转计划、选配种记录、产仔或产卵记录、病例病志、死亡报告书、死亡登记表、检免疫统计表、饲料配合表、饲料消耗记录、谱系登记表、后裔鉴定表等。

3．药用部分的采收时间、采收量、鲜重和加工、干燥、干燥减重、运输、贮藏等。

4．气象资料及小气候的记录等。

5．药材的质量评价：药材性状及各项检测的记录。

第五十四条　所有原始记录、生产计划及执行情况、合同及协议书等均应存档，至少保存5年。档案资料应有专人保管。

第十章　附则

第五十五条　本规范所用术语：（一）中药材 指药用植物、动物的药用部分采收后经产地初加工形成的原料药材。

（二）中药材生产企业 指具有一定规模、按一定程序进行药用植物栽培或动物养殖、药材初加工、包装、储存等生产过程的单位。

（三）最大持续产量 即不危害生态环境，可持续生产（采收）的最大产量。

（四）地道药材 传统中药材中具有特定的种质、特定的产区或特定的生产技术和加工方法所生产的中药材。

（五）种子、菌种和繁殖材料 植物（含菌物）可供繁殖用的器官、组织、细胞等，菌物的菌丝、子实体等；动物的种物、仔、卵等。

（六）病虫害综合防治 从生物与环境整体观点出发，本着预防为主的指导思想和安全、有效、经济、简便的原则，因地制宜，合理运用生物的、农业的、化学的方法及其它有效生态手段，把病虫的危害控制在经济阈值以下，以达到提高经济效益和生态效益之目的。

（七）半野生药用动植物 指野生或逸为野生的药用动植物辅以适当人工抚育和中耕、除草、施肥或喂料等管理的动植物种群。

第五十六条　本规范由国家药品监督管理局负责解释。

第五十七条　本规范自2002年6月1日起施行。

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-plasma resources of medicinal plants and animals should be protected.

Chapter IV Management for Cultivation and Rearing

Section 1 Management for Cultivation of Medicinal Plants

Article 11 An appropriate area for cultivation should be determined and standard operating procedures for cultivation should be formulated subject to the growing and developing needs for medicinal plants.

Article 12 Types, period and amount of fertilization should be determined according to the nutritional requirements of the medicinal plants and soil fertility. Organic manures should be the main fertilizing agent, and fertilizers could be applied sparingly in accordance with the growing and developing needs of plants.

Article 13 The use of farmyard manures could be allowed when they are thoroughly composted and meet the sanitary standards. The use of house garbage, industrial wastes, hospital refuse and feces are strictly prohibited.

Article 14 Timely and appropriate irrigation and drainage should be carried out in accordance with the needs of plants in different periods of growth, and the conditions of climate and soil moisture. The soil should be well aerated.

Article 15 Field management should be strengthened in accordance with growing and developing characteristics of medicinal plants and their parts for use, and topping, deflowering, pruning, shading and other measures should be taken timely to adjust the growth and development of plants so as to increase the yield of the crude drugs and maintain the consistency of quality.

Article 16 Integrated pest management should be adopted for the control of diseases and pests. If necessary, minimum effective input of pesticides with high-efficacy, hypo-toxicity and low-residue could be used according to the Regulations for Pesticides Management of the People's Republic of China, so as to reduce residues of pesticides, avoid heavy metals contamination and protect the ecological environment.

Section 2 Management for Rearing Medicinal Animals

Article 17 Standard operating procedures and relevant rearing methods should be carried out according to the living environment, dietary needs, behavioral character and adaptability of medicinal animals.

Article 18 Fodder should be formulated and fed timely and in quantity, in accordance with seasonal behaviour, activities day and night, period of growth and physiological character of the animals. Fine fodder, vitamins, minerals and other essential additives should be replenished at appropriate time and with appropriate quantities. Hormones, para-hormones, and other additives, are not allowed to be added. Feeds and additives should not be contaminated.

Article 19 Time and frequency of water supply for medicinal animals should be based on seasons, temperature, ventilation etc. Herbivores should be adequately fed with succulence for water supplement.

Article 20 Sites with appropriate space and security facilities should be established according to the habit and behaviour of medicinal animals.

Article 21 Rearing areas should be kept clean and sanitary.Disinfections practices should be established to disinfect the living places and equipment periodically with appropriate disinfectants. Personnel access to the rearing sites should be controlled.

Article 22 Prevention should be emphasized for the prevention and treatment of epidemic diseases of medicinal animals. Vaccination should be periodically conducted.

Article 23 Rearing areas should be appropriately divided to keep a proper density for medicinal animals that are reared in groups. Sick animals should be timely isolated. The animal（s） with infectious diseases should be culled, and cremated or buried deeply.

Article 24 The composition and structure of the animal population should be determined and adjusted based on a rearing plan and breeding needs.

Article 25 Poisoned and infected medicinal animals are prohibited from processing into Chinese crude drugs.

Chapter V Collection and Primary Processing

Article 26 Collection of wild and semi-wild medicinal plants or animals should conform to the principle of "maximum sustainable yield". Their fostering, rotation and conservation should be planned and carried out to benefit their propagation and renewal of resources.

Article 27 Appropriate collection time （season and years） and methods should be determined in accordance with the quality and yield of the plants or the number of animals bred and with reference to traditional experience, etc.

Article 28 Machines and tools for collection should be kept clean and free of contamination, and stored in a dry place inaccessible for insects, rodents, poultry and livestock.

Article 29 In the course of collection and primary processing, non-medicinal portions and foreign matter should be removed, especially weeds and toxic substances. Damaged and perished parts should be excluded.

Article 30 After being collected, the medicinal parts should be selected, washed, cut or trimmed, etc. Those that need drying should be dried timely by using appropriate methods and techniques, with controlled temperature and humidity. The contamination of Chinese crude drugs should be prevented and degradation of their active constituents should be avoided.

Article 31 Chinese crude drugs to be used fresh may be stored under cool conditions, in sands, in jars, or by biological and other fresh-preserving measures. The use of anti-oxidant agents and preservatives should preferably be avoided. If used, they must conform to national regulatory requirements on food additives.

Article 32 Processing sites should be clean and well ventilated, and fitted with awnings, canopies and devices to prevent entry by insects, rodents, poultry and livestock.

Article 33 Geo-authentic （Di Dao） crude drugs should be processed according to traditional methods. Any change in methods should be based on sufficient experimental data, and should not affect the quality of the Chinese crude drugs.

Chapter VI Packaging, Transportation and Storage

Article 34 Prior to packaging, crude drugs should be checked, and substandard ones and foreign matter should be eliminated. The standard operating procedure for packaging should be followed and a batch packaging record should be documented. The record should include product name, specification, production site, batch number, weight, operator number and packaging date, etc.

Article 35 The packaging materials to be used should be clean, dry, uncontaminated and undamaged, and conform to the quality requirements for crude drugs.

Article 36 On each package of the crude drugs, the product name, specification, production site, batch number, packaging date and the name of producer should be indicated and a sign for qualified products should be marked.

Article 37 Fragile crude drugs should be packaged in hard boxes. Poisonous/toxic, narcotic and precious crude drugs should be specially packaged, and appropriately marked.

Article 38 The crude drugs should not be put together with poisonous/toxic, hazardous and volatile materials during their transportation. Containers should be well-aerated to keep the crude drugs dry, and moisture proof measures should be in place.

Article 39 The warehouse for crude drugs should be airy and dry, and it should protect the crude drugs from direct sunlight. If necessary, air conditioners and dehumidifiers should be installed. Measures to prevent entry into the warehouse from insects, rodents, poultry and livestock should be taken. Floors should be neat and tidy, free from cracks and easy to clean.

The crude drugs should be placed on shelves and kept at an adequate distance from the wall, and avoid moth-eating, mould growth, rotting and oil spillage. Regular check should be conducted.

Modern technology and equipment for storage should be considered while traditional methods are applied.

Chapter VII Quality Management

Article 40 The producer should establish a quality management department which is responsible for supervision and quality control for the entire production process, and should have adequate staff, premises, instruments and equipment to meet the requirements of the scale of production and species identification.

Article 41 The quality management department has the following main esponsibilities:

1.to monitor the environment and hygienic management;

2.to test production materials, packaging materials and the crude drugs, and to issue testing reports;

3.to develop training plans and supervise their implementation;

4.to formulate and manage quality documents, and to manage the original records of production, packaging, testing, etc.

Article 42 Prior to packaging, the quality control department should test each batch of the crude drugs in accordance with the national or approved standards for Chinese crude drugs. The testing items should at least include macroscopic characters and identification, impurities, moisture, ash and acid insoluble ash, extracts, and assay for marker or active constituents. Pesticide residue, heavy metals and microbiological limits should comply with the national standards and the relevant requirements.

Article 43 The testing reports should be signed by the operator and the responsible person of the quality control department, and then filed.

Article 44 The rejected Chinese crude drugs should not be released and marketed.

Chapter VIII Personnel and Facilities

Article 45 The responsible person for technology of a producer should possess qualifications of college education or above in pharmacy, agronomy, animal husbandry or the relevant specialties, and have experience in the production of crude drugs.

Article 46 The responsible person of the quality management department should possess qualifications of college education or above, and have experience in quality management of crude drugs.

Article 47 The personnel engaged in the production of crud e drugs should have basic knowledge of traditional Chinese pharmacy, agronomy or animal husbandry, and should receive training on production techniques, safety, and hygiene. Staff engaged in the field work should be familiar with cultivation techniques, especially the use of pesticides and safety protection; those engaged in rearing should be familiar with rearing techniques.

Article 48 The personnel engaged in processing, packaging or testing should undergo health examinations regularly and those suffering from infectious diseases, dermatitis or open wounds shall not be allowed to conduct work which is in direc t contact with crude drugs. The producer should designate a person to be responsible for checking sanitation and hygiene.

Article 49 The personnel engaged in the production of Chinese crude drugs are required to participate in regular training and examination.

Article 50 Toilets or washrooms should be set up in the production site of Chinese crude drugs. Excrement should not contaminate the environment or products.

Article 51 The applicable range and precision of instruments, meters, measures, weighers and balances, etc. used in production and testing, should conform to the elevant requirements, their performance status should be clearly indicated, and calibration should be conducted regularly.

Chapter IX Documentation

Article 52 The producer should formulate its standard operating procedures for production and quality management.

Article 53 Detailed records for the entire production process of each crude drug should be documented, and if necessary, photos or images might be attached, which should include:

1.origin of seeds, strains and propagation materials;

2.production techniques and process;

a.Seeding time, quantity and area of medicinal plants; seedling, transplantation, and the type, application schedule, quantity and usage of fertilizer; sort, quantity, application schedule and usage of pesticide, micro-biocide or herbicide;

b.Rearing daily record, turnover plan, breeding records, spawning records, medical records, death reports, death registration, records for quarantine and vaccination, feed formulae, feed consumption records, pedigree records and offspring identification of medicinal animals;

c.Collection time and yield, fresh weight and processing, drying and drying loss, transport and storage of medicinal parts;

d.Meteorological information, microclimate records;

e.Quality evaluations of crude drugs: description of macroscopic characters of crude drugs and records of test results.

Article 54 All the original records, production plans and their execution details, contracts or agreements etc. should be filed and kept properly for at least five years. The documents should be kept by a designated person.

Chapter X Supplementary Provisions

Article 55 Terms used in this GAP are defined as follows:

1）Chinese crude drugs refer to the raw medicinal materials from the medicinal parts of plants or animals, which are collected and primarily processed.

2）Producers of Chinese crude drugs refer to units with certain scale, which conduct the cultivation of medicinal plants, or rearing of medicinal animals, primary processing, packaging and storage according to relevant procedure.

3）Maximum sustainable yield refers to the maximum yield of sustainable production （collection）, without detriment to the ecological environment;

4）Geo-authentic （Di Dao） crude drugs refer to those of traditional Chinese crude drugs with specific germ plasma, production sites, or with specific production techniques and processing methods;

5）Seeds, strains and propagation materials refer to reproduction organs, tissues, cells, etc. of plants （fungi）, and mycelia, sporocarp, etc. of fungi; a nd stud stock, breeds, eggs, etc. of animals.

6）Integrated pest management means to minimize the damage of pests and diseases under economic threshold as to improve economic and ecological interests, by biological, agricultural, chemical and/or other effective ecological means, considering local conditions. It should be prevention-oriented and based on the principle of safety, efficacy, economy and simplicity and convenience, and should integrate biological and environmental viewpoints.

7）Semi-wild medicinal animals/plants refer to wild animals/plants or those derived from cultivation with proper management, and intertilling, weeding, fertilizing or feeding, etc.

Article 56 The State Drug Administration is responsible for the interpretation of this GAP.

Article 57 This GAP shall come into force as of 1st June 2002