Good Manufacturing Practice for Pharmaceutical Products 中国新版GMP 2010英文版精品.pdfVIP

Good Manufacturing Practice for Pharmaceutical Products (Revised in 2010) (Decree No.79 of the Ministry of Health) The Good Manufacturing Practice for Pharmaceutical Products (Revised in 2010) was reviewed and adopted at the Executive Meeting of the Ministry of Health on Oct. 19, 2010, and it is hereby promulgated and shall go into effect as of March 1, 2011. Minister Chen Zhu Jan.17, 2011 Chapter 1 General Provisions Article 1 This Practice is enacted in accordance with the Drug Administration Law of the Peoples Republic of China and the Regulations for The Implementation of the Drug Administration Law of the Peoples Republic of China for the purpose of regulating the management of drug manufacturing quality. Article 2 The manufacturers shall establish drug quality management system, which shall cover all the factors affecting drug quality including all organized and planned activities to ensure that drug quality is in compliance with requirements of intended use. Article 3 This Practice as a part of quality management system is the basic requirements for drug manufacturing management and qualitycontrol aiming at minimizing the risk of contamination, cross-contamination, mix-up and errors during production in order to ensure that the production is consistent and stable, and drug in compliance with requirements of intended use and registration. Article 4 The manufacturers shall strictly implement this Practice, adhere to be honest and true to one’s promise and prohibit any false and cheating ac