SFDA正式发布新版GMP英文版[精品].doc

? Chinese(GB) ????Contact SFDA? ? Normative Documents 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 promulgated and shall go into effect as of March 1, 2011. ??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????Chen Zhu???????????????????????????????????????????????????????????????????????????????????????????? Minister of MOH???????????????????????????????????????????????????????????????????????????????????????????? January 17, 2011????????????????????????????????????? ???Good Manufacturing Practice (GMP) for Drugs??????????????????????????????????????????????????? ? Chapter 1 General ProvisionsArticle 1:?These provisions of Good Manufacturing Practice (GMP) for Drugs, in accordance with the Drug Administration Law of the People’s Republic 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 that 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 drugs, 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 i