中国GMP英文版精选.doc

Good Manufacturing Practice for Pharmaceutical Products (Amended in 1998)SDA Order #9 ? Chapter 1: General Provisions Article 1: This Regulation is enacted in accordance with the Drug Administration Law of The Peoples Republic of China. 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. 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. Article 4: The enterprise personnel responsible for supervision of manufacture and quality control shall, at a minimum, have a bachelors 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. 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. 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. Person