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".
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第一条 根据《中华人民共和国药品管理法》规定，制定本规范。
c语言学习班 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 process of drug preparations and to the key manufacturing process of raw materials which may cau 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
六级翻译技巧
Article 3: A pharmaceutical enterpri 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 enterpri 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 shal
l, 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.exoplanet
Personnel engaged in the production and quality control of products with high organic activity, high toxicity, strong contamination, high nsitivity and other substances with spe
cial 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。
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成都美发 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。
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Chapter 3: Building and Facilities第三章 厂房与设施
Article 8: A pharmaceutical enterpri 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。
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Article 11: The ea 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 ea 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 tho 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。
