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1、 CFDA Constructed and Maintained by the Information Center of SFDA 第 1 页 共 53 页 Good Manufacturing Practice for Drugs 2010 Revision MOH Decree No 79 The Good Manufacturing Practice for Drugs 2010 Revision adopted at the executive meeting of the Ministry of Health on October 19 2010 is hereby promulg
2、ated and shall go into effect as of March 1 2011 Chen Zhu Minister ofMOH January 17 2011 Good Manufacturing Practice GMP for Drugs Chapter 1 General Provisions Article 1 These provisions of Good Manufacturing Practice GMP for Drugs in accordance with the Drug Administration Law of the People s Repub
3、lic of China and the Regulations for Implementation of the Drug Administration Law of the People s Republic of China are enacted to regulate the manufacturing and quality management of Drugs Article 2 The manufacturer should establish a quality management system The system should cover all factors t
4、hat influence the quality of drugs including all organized and planned activities with the objective of ensuring that the drugs are of the quality required for their intended use Article 3 GMP as part of the quality management system is the basic requirement of production and quality control of drug
5、s to ensure the products are consistently manufactured in accordance with the registration requirements and are suitable for their intended use by minimizing the risks of contamination cross contamination and mixups or errors in manufacturing process Article 4 The manufacturer should strictly implem
6、ent GMP with integrity Any falsification and fraud is forbidden Chapter 2 Quality Management CFDA Constructed and Maintained by the Information Center of SFDA 第 2 页 共 53 页 Section 1 Principle Article 5 The manufacturer should establish a quality objective to meet quality management requirements so t
7、hat all registration requirements related to drug safety efficacy and quality are systematically implemented throughout the entire process of production control product release storage and distribution to ensure that the products are manufactured in accordance with the registration requirements and
8、are suitable for their intended use Article 6 The attainment of the quality objective is the responsibility of senior management and requires the participation and commitment by staff at all levels within the manufacturer by the manufacturer s suppliers and by the distributors Article 7 The manufact
9、urer should be adequately resourced with competent personnel suitable and sufficient premises equipment and facilities for achieving its quality objective Section 2 Quality Assurance Article 8 Quality Assurance is a part of the quality management system The manufacturer should establish the Quality
10、Assurance system with the support of a complete documentation system to ensure its effective operation Article 9 The system of Quality Assurance should ensure that 1 Drugs are designed and developed in a way that takes account of the requirements of GMP 2 Production and quality control operations ar
11、e in compliance with GMP 3 Managerial responsibilities are clearly specified 4 Arrangements are made for the purchase and use of the correct starting and packaging materials 5 All necessary controls on intermediate products are effectively carried out 6 Qualifications and validations are carried out
12、 7 Drugs are correctly processed checked tested and verified according to the defined procedures 8 Each batch of products is not released before the approval of the Qualified Person 9 Satisfactory arrangements exist to ensure that the drugs are stored distributed and subsequently handled 10 Self ins
13、pection is regularly carried out to appraise the effectiveness and applicability of the Quality Assurance system according to the procedures Article 10 The basic requirements of production and quality control are that CFDA Constructed and Maintained by the Information Center of SFDA 第 3 页 共 53 页 1 A
14、ll manufacturing processes are clearly defined systematically reviewed and shown to be capable of consistently manufacturing drugs of the required quality and complying with their specifications 2 Steps of manufacturing processes and significant changes to the process are validated 3 All necessary r
15、esources are provided including 1 Appropriately qualified and trained personnel 2 Adequate premises and space 3 Suitable equipment and services 4 Correct starting materials packaging materials and labels 5 Approved master manufacturing documents and operation procedures 6 Suitable storage and transp
16、ort 4 Instructions and procedures 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 recorded accordingly 7 Records of manufacture and distribution which enable the complete history of a batch to be traced are retained in a comprehensible and accessible form 8 The distribution of the products minimizes any risk to their quality 9 Asystem is available
