GMP规范中英文对照.docx

  GMP规范中英文对照
Chapter 1: General Provisions第一章  总    则
Article 1: This Regulation is enacted in accordance with the "Drug Administration Law of The People's Republic of China".
第一条 根据《中华人民共和国药品管理法》规定，制定本规范。
 Article 2: This Regulation is promulgated as the basic guideline for manufacturing and quality control of pharmaceutical products. This Regulation shall be applicable to all the manufacturing processes of drug preparations and to the key manufacturing processes of raw materials which may cause variation in the quality of finished products.
第二条本规范是药品生产和质量管理的基本准则。适用于药品制剂生产的全过程、原料药生产中影响成品质量的关键工序。
Chapter 2: Organization and Personnel
Article 3: A pharmaceutical enterprise shall establish production and quality control departments. The responsibilities of departments at all levels and personnel shall be clarified, and each department shall be staffed by an appropriate number of management and technical personnel with expert knowledge, manufacturing experience and organization ability.   第三条药品生产企业应建立生产和质量管理机构。各级机构和人员应职责明确，并配备一定数量的与药品生产相适应的具有专业知识、生产经验及组织能力的管理人员和技术人员。
Article 4: The enterprise personnel responsible for supervision of manufacture and quality control shall, at a minimum, have a bachelor's degree in medicine, pharmaceuticals, or related sciences, and have appropriate experience in drug manufacturing and quality control. They shall be responsible for the implementation of the GMP regulations and the quality of products. 第四条企业主管药品生产管理和质量管理的负责人应具有医药或相关专业大专以上学历，有药品生产和质量管理经验，对本规范的实施和产品质量负责。
Article 5: The responsible person of the manufacture and quality control departments shall, at a minimum, have a college degree of medicine, pharmaceuticals or related sciences, have actual management experience in production and quality control, and have the ability to correctly decide and handle practical problems in production and quality control.
The managers of production and quality control departments shall be independent of each other. 第五条药品生产管理部门和质量管理部门的负责人应具有医药或相关专业大专以上学历，有药品生产和质量管理的实践经验，有能力对药品生产和质量管理中的实际问题作出正确的判断和处理。
药品生产管理部门和质量管理部门负责人不得互相兼任
Article 6: All personnel engaged in drug manufacture and quality control shall have been professionally and technically trained so as to acquire the basic theory and practical technical skills.
Personnel engaged in the production and quality control of products with high organic activity, high toxicity, strong contamination, high sensitivity and other substances with special requirements shall have received corresponding professional technical training. 第六条从事药品生产操作及质量检验的人员应经专业技术培训，具有基础理论知识和实际操作技能。

    对从事高生物活性、高毒性、强污染性、高致敏性及有特殊要求的药品生产操作和质量检验人员应经相应专业的技术培训。

Article 7: Personnel at all levels who are engaged in drug manufacturing shall be trained and pass examinations in accordance with the requirements of this Regulation. 第七条对从事药品生产的各级人员应按本规范要求进行培训和考核。

Chapter 3: Building and Facilities第三章  厂房与设施

Article 8: A pharmaceutical enterprise shall be located in a clean environment. The surface of the ground and roads and transportation of the plant area shall not be a source of contamination of drug products. The general lay-out of the production, administration, living and ancillary areas shall be appropriately arranged and not interfere with each other. 第八条药品生产企业必须有整洁的生产环境；厂区的地面、路面及运输等不应对药品的生产造成污染；生产、行政、生活和辅助区的总体布局应合理，不得互相妨碍。
Article 9: Buildings shall be appropriately located in accordance with the technological process and requisite cleanness levels. The manufacturing operations undertaken in the same and nearby areas shall not interfere with each other. 第九条厂房应按生产工艺流程及所要求的空气洁净级别进行合理布局。同一厂房内以及相邻厂房之间的生产操作不得相互妨碍。
Article 10: Buildings shall have the facilities to protect against the entrance of vermin and other animals. 第十条厂房应有防止昆虫和其他动物进入的设施。
Article 11: The ease and convenience to conduct cleaning shall be considered in the design and construction of buildings. The interior surfaces of the clean room (area) shall be smooth, without cracks, with airtight junction points. The interior surfaces shall not shed any particulate granules and shall withstand washing and disinfecting. The joints between walls and floors are preferably constructed with round corners or by other means so as to reduce the collection of dust and for ease of cleaning. 第十一条在设计和建设厂房时，应考虑使用便于进行清洁工作。洁净室（区）的内表面应平整光滑、无裂缝、接口严密、无颗粒物脱落，并能耐受清洗和消毒，墙壁与地面的交界处宜成弧形或采取其他措施，以减少灰尘积聚和便于清洁。
Article 12: In production and storage areas, there shall be adequate floor and air space for the orderly placement of equipment and materials so as to facilitate production, operations, storage of materials, in-process products, finished products and those under quarantine, and to the greatest degree possible minimize errors and cross-contamination. 第十二条生产区和储存区应有与生产规模相适应的面积和空间用以安置设备、物料，便于生产操作，存放物料、中间产品、待验品和成品，应最大限度地减少差错和交叉污染。
Article 13: The various pipes, light fixtures, ventilation points and other public facilities in the clean room (area) shall be designed and installed so as to avoid areas being difficult to clean. 第十三条洁净室(区)内各种管道、灯具、风口以及其他公用设施，在设计和安装时应考虑使用中避免出现不易清洁的部位。
Article 14: The clean room (area) shall be provided with sufficient lighting according to the production requirements. Illumination for main production rooms shall be 300 Lux. For production areas with special requirements, appropriate lighting shall be installed. Emergency lighting shall be provided in the facilities. 第十四条洁净室(区)应根据生产要求提供足够的照明。主要工作室的照度宜为300勒克斯；对照度有特殊要求的生产部位可设置局部照明。厂房应有应急照明设施。
Article 15: Air supplied into the clean room (area) must be purified and the clean level of the area shall be classified in accordance with the requirements of the production process. The number of microorganisms and particulates in the air of the clean room (area) shall be tested periodically and the results shall be filed. 第十五条进入洁净室(区)的空气必须净化，并根据生产工艺要求划分空气洁净级别。洁净室(区)内空气的微生物数和尘粒数应定期监测，监测结果应记录存档。
Article 16: The windows, ceilings, entering pipes, ventilation, light fixtures and joints between walls and ceilings in clean room (area) shall be airtight. The static pressure difference between areas of different cleanliness class shall be maintained more than 5 Pa, the static pressure difference between clean rooms (area) and the atmosphere outside shall be maintained at more than 10 Pa and devices for indicating pressure difference shall be installed. 第十六条洁净室(区)的窗户、天棚及进入室内的管道、风口、灯具与墙壁或天棚的连接部位均应密封。空气洁净级别不同的相邻房间之间的静压差应大于5帕，洁净室(区)与室外大气的静压差应大于10帕，并应有指示压差的装置。
Article 17: The temperature and relative humidity in the clean rooms (areas) shall comply with the requirements of the production process. When there are no special requirements, the temperature and relative humidity may be controlled at 18-26¡æ and 45-65%, respectively. 第十七条洁净室(区)的温度和相对湿度应与药品生产工艺要求相适应。无特殊要求时，温度应控制在18～26℃，相对湿度控制在45～65％。
Article 18: Sinks and drains in clean rooms (areas) shall be installed so that drugs will not be contaminated. 第十八条洁净室(区)内安装的水池、地漏不得对药品产生污染。
Article 19: Measures shall be taken to protect against cross contamination of personnel and materials entering or leaving clean rooms (areas) of different cleanliness class. 第十九条不同空气洁净度等级的洁净室(区)之间的人员及物料出入，应有防止交叉污染的措施。
Article 20: Separates buildings and facilities must be used in the production of highly sensitive drugs, such as penicillin. In filling rooms of these drugs a negative pressure shall be maintained relative to other rooms. Before being discharged outside the room, the used steam (or air) shall be cleaned so as to comply with the requirements. The opening for the discharge of used steam shall be far away from the air intake or other air cleaning systems. Drugs with the structure of B-lactam must have specialized equipment and a separate air cleaning system and the production area must be strictly separated from other production areas. 第二十条生产青霉素类等高致敏性药品必须使用独立的厂房与设施，分装室应保持相对负压，排至室外的废气应经净化处理并符合要求，排风口应远离其它空气净化系统的进风口；生产β-内酰胺结构类药品必须使用专用设备和独立的空气净化系统，并与其它药品生产区域严格分开。
Article 21: Buildings for production of contraceptives shall be separated from those of other drugs. An independent dedicated air cleaning system shall be installed. Chemical drugs such as hormones and anti-tumor pharmaceuticals shall not use the same equipment or air-cleaning system with other drugs; however, if such use cannot be avoided, effective precautions must be taken and necessary validations obtained.
Dedicated and safe equipment shall be used in the processing, packaging and storage of radioactive drugs. Air discharged from the production area shall not be circulated for use. Discharged air shall not contain radio active particles and the requirements and regulations regarding radiation protection shall be complied with. 第二十一条避孕药品的生产厂房应与其它药品生产厂房分开，并装有独立的专用的空气净化系统。生产激素类、抗肿瘤类化学药品应避免与其他药品使用同一设备和空气净化系统；不可避免时，应采用有效的防护措施和必要的验证。

    放射性药品的生产、包装和储存应使用专用的、安全的设备，生产区排出的空气不应循环使用，排气中应避免含有放射性微粒，符合国家关于幅射防护的要求与规定。

Article 22: The processing or filling of: bacterial and viral strains used for production or non-production, cells used for production or non-production, wild and attenuated strains, dead and live strains, pre-detoxified and post-detoxified products, live or inactivated vaccines, human blood products and preventive products; shall not be conducted in the same building, and their storage shall be strictly separated from each other. Treatment and filling of different types of live vaccines shall be separated from each other. The production area for wild microorganisms and spore-forming microorganisms preparations shall be under negative pressure relative to neighboring areas and shall have an independent air cleaning system. 第二十二条生产用菌毒种与非生产用菌毒种、生产用细胞与非生产用细胞、强毒与弱毒、死毒与活毒、脱毒前与脱毒后的制品和活疫苗与灭活疫苗、人血液制品、预防制品等的加工或灌装不得同时在同一生产厂房内进行，其贮存要严格分开。不同种类的活疫苗的处理及灌装应彼此分开。强毒微生物及芽胞菌制品的区域与相邻区域应保持相对负压，并有独立的空气净化系统。
Article 23: The pretreatment, extraction, concentration (evaporation) of TCM and the washing and treatment areas of animal organs and tissues shall be strictly separated from the production areas of other preparations.
The steaming, stir-frying, roasting and baking processes for preparing Chinese crude drugs shall be carried out in areas equipped with ventilation, de-fuming, dust extraction, and cooling facilities. The process of selection, slicing, and mashing shall be carried out in areas equipped with effective dust-catching and ventilation facilities. 第二十三条中药材的前处理、提取、浓缩以及动物脏器组织的洗涤或处理等生产操作，必须与其制剂生产严格分开。

    中药材的蒸、炒灸、煅等炮制操作应有良好的通风、除烟、除尘、降温设施。筛选、切片、粉碎等操作应有效的除尘、排风设施。

Article 24: The buildings shall be provided with dust protection devices and dust-catching devices if necessary. 第二十四条厂房必要时应有防尘及捕尘设施。
Article 25: Air directly in contact with products which has been dried, compressed or made inert shall be cleaned and shall comply with the requirements of production. 第二十五条与药品直接接触的干燥用空气、压缩空气和惰性气体应经净化处理，符合生产要求。
Article 26: Storage areas shall be kept clean and dry. The facilities of lighting, ventilation, etc. as well as temperature control and humidity shall comply with the storage requirements and shall be periodically tested.
Storage areas may be equipped with sampling room(s) for raw materials provided the air cleanliness class is the same as that of production requirements. If sampling is not conducted in a sampling room, measures to prevent contamination and cross-contamination shall be adopted. 第二十六条仓储区要保持清洁和干燥。照明、通风等设施及温度、湿度的控制应符合储存要求并定期监测。

    仓储区可设原料取样室，取样环境的空气洁净度等级应与生产要求一致。如不在取样室取样，取样时应有防止污染和交叉污染的措施。

Article 27: In accordance with requirements of the production process, the air cleanliness class of the weighing room and material preparation (to get material ready for production) room in the clean room (area) shall be the same as the production requirements and shall be provided with facilities to catch dust and to protect against cross contamination. 第二十七条根据药品生产工艺要求，洁净室(区)内设置的称量室和备料室，空气洁净度等级应与生产要求一致，并有捕尘和防止交叉污染的设施。
Article 28: Rooms for testing, Chinese crude drug specimens, sample retention and other similar laboratories as determined by the quality control department shall be separated from the production area. Areas for biological, micro-biological, or radioactive isotope tests shall be separated from each other. 第二十八条质量管理部门根据需要设置的检验、中药标本、留样观察以及其它各类实验室应与药品生产区分开。生物检定、微生物检定和放射性同位素检定要分室进行。
Article 29: Instruments and meters with special requirements shall be placed in a dedicated instrument room and facilities to protect against static electricity, vibration, humidity or other external factors shall be provided. 第二十九条对有特殊要求的仪器、仪表，应安放在专门的仪器室内，并有防止静电、震动、潮湿或其它外界因素影响的设施。
Article 30: Any animal experiment house shall be strictly separated from other areas and its design and construction shall comply with relevant national regulations. 第三十条实验动物房应与其他区域严格分开，其设计建造应符合国家有关规定。

Chapter 4: Equipment第四章  设    备

Article 31: The design, selection and installation of equipment shall comply with the production requirements and the equipment shall be easy to clean, disinfect or sterilize, convenient to operate and maintain and be able to prevent errors and minimize contamination. 第三十一条设备的设计、选型、安装应符合生产要求，易于清洗、消毒或灭菌，便于生产操作和维修、保养，并能防止差错和减少污染。
Article 32: The surface of equipment which comes into direct contact with drugs shall be smooth and even, easy to clean and disinfect and be corrosion resistant. The lubricants or coolant of the equipment shall not contaminate the products or their containers. 第三十二条与药品直接接触的设备表面应光洁、平整、易清洗或消毒、耐腐蚀，不与药品发生化学变化或吸附药品。设备所用的润滑剂、冷却剂等不得对药品或容器造成污染。
Article 33: The main fixed pipelines connected to equipment shall be marked with the name of material inside the pipe and flow direction. 第三十三条与设备连接的主要固定管道应标明管内物料名称、流向。
Article 34: The preparation, storage and distribution of purified water and water for injection shall be protected from microorganism breeding and contamination. Storage tanks and delivery pipelines shall be made from non-toxic and corrosion-resistant materials. Inaccessible places and dead spots shall be avoided in design and installation of pipelines. Storage tanks and pipelines shall be cleaned periodically. Vents of tanks of water for injection shall be protected by a non-fiber-releasing hydrophobic microbial air filter. Water for injection shall be stored at 80¡æ minimum, or at 4¡æ maximum or maintained in constant circulation at 65¡æ minimum. 第三十四条纯化水、注射用水的制备、储存和分配应能防止微生物的滋生和污染。储罐和输送管道所用材料应无毒、耐腐蚀。管道的设计和安装应避免死角、盲管。储罐和管道要规定清洗、灭菌周期。注射用水储罐的通气口应安装不脱落纤维的疏水性除菌滤器。注射用水的储存可采用80℃以上保温、65℃以上保温循环或4℃以下存放。
Article 35: Each instrument, meter, weighing and measuring device used for production and testing shall have a range of operation and precision meeting production and testing requirements and shall be clearly labeled as certified and be calibrated periodically. 第三十五条用于生产和检验的仪器、仪表、量具、衡器等，其适用范围和精密度应符合生产和检验要求，有明显的合格标志，并定期校验。
Article 36: Equipment for production shall have its condition clearly marked and shall be periodically maintained and validated. It's installation, maintenance and repair shall not affect product quality. Non-conforming equipment shall be moved from the production area, if possible, and shall be clear