cfda2010版gmp英文版

1、http://eng.sfda.gov.cn/WS03/CL0768/65113.html ? CFDAConstructed and Maintained by the Information Center of SFDA第 1 頁 共 53 頁Good Manufacturing Practice for Drugs (2010 Revision)( MOH DecreeNo. 79 )The Good Manufacturing

2、Practice for Drugs (2010 Revision), adopted at the executive meeting of the Ministry ofHealth on October 19, 2010, is hereby promulgated and shall go into effect asof March 1, 2011.Chen ZhuMinister of MOHJanuary17, 2011G

3、ood Manufacturing Practice (GMP) for DrugsChapter 1 General ProvisionsArticle 1: These provisions of Good Manufacturing Practice (GMP) for Drugs, in accordance with the DrugAdministration Law of the People ’ s Republic o

4、f China and the Regulations for Implementation of the DrugAdministration Law of the People ’ s Republic of China, are enacted to regulate the manufacturing and qualitymanagement of Drugs.Article 2: The manufacturer shoul

5、d establish a quality management system. The system should cover all factorsthat influence the quality of drugs, including all organized and planned activities with the objective of ensuring thatthe drugs are of the qual

6、ity required for their intended use.Article 3: GMP, as part of the quality management system, is the basic requirement of production and qualitycontrol of drugs, to ensure the products are consistently manufactured in ac

7、cordance with the registrationrequirements, and are suitable for their intended use, by minimizing the risks of contamination, cross-contaminationand mixups or errors in manufacturing process.Article 4: The manufacturer

8、should strictly implement GMP with integrity. Any falsification and fraud isforbidden.Chapter 2 Quality Managementhttp://eng.sfda.gov.cn/WS03/CL0768/65113.html ? CFDAConstructed and Maintained by the Information Center o

9、f SFDA第 3 頁 共 53 頁1. All manufacturing processesare clearly defined, systematically reviewed and shown to be capable of consistentlymanufacturing drugs of the required quality and complying with their specifications.2. S

10、teps of manufacturing processesand significant changes to the process are validated.3. All necessaryresourcesare provided including:1) Appropriately qualified andtrained personnel;2) Adequate premises and space;3) Suitab

11、le equipment and services;4) Correct starting materials, packaging materials and labels;5) Approved master manufacturing documents and operation procedures;6) Suitable storageand transport.4. Instructions and procedures

12、are written in clear and unambiguous language.5. Operators are trained to carry out procedures correctly.6. Records should be made during the entire manufacture and any deviations are investigated and recordedaccordingly

13、.7. Records of manufacture and distribution, which enable the complete history of a batch to be traced, are retainedin a comprehensible and accessibleform.8. The distribution of the products minimizes any risk to their q

14、uality.9. A system is available to recall any batch of product, from sale or supply.10. Complaints about marketed products are examined, the causesof quality defects investigated and appropriatemeasurestaken in respectof

15、 the defective products and to prevent reoccurrence.Section 3 Quality ControlArticle 11: Quality Control is concerned with organization and documentation, and with sampling, testing and etc.,which ensure that the necessa