GMP规范中英文对照

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。