药品生产质量管理规范（2010年修订）-英文版.docVIP

Good Manufacturing Practice for Pharmaceutical Products (Amended in 2010) SDA Order #79 Order by Ministry of Health of the People’s Republic of China 　　　　　　Published on February 12, 2011 No. 79 Good Manufacturing Practice for Pharmaceutical Products (Amended in 2010) has passed by Affairs Meeting on October 19, 2010. This Regulation is now published and shall be effective from March 1, 2011. 　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　Director Zhu CHEN 　　　　　　　　　　　　　　　　　　　　　　　 　　　　January 17, 2011 Chapter 1 General Provisions Article 1 In order to standardize good manufacturing for pharmaceutical products, this Regulation is enacted in accordance with the “Drug Administration Law of the People’s Republic of China” and “The Regulation on the Implementation of Drug Administration Law of the People’s Republic of China”. Article 2 A pharmaceutical enterprise shall establish pharmaceutical goods’ quality control system. The system shall contain all factors which may affect the quality of pharmaceutical goods, including all organized and planned activities ensuring pharmaceutical goods’ quality in accordance with intending purpose. Article 3 This Regulation is part of quality control system, is basic requirement for manufacturing and quality control of pharmaceutical products. This Regulation aims to reduce the risks in pharmaceutical goods’ manufacturing process at its maximum, such as pollution, cross pollution and confusion, mistake, ensure for continuous stably manufacturing pharmaceutical goods in accordance with intending purpose and registered requirements. Article 4 The enterprise shall obey this Regulation strictly, insist on honesty and keep faith, prohibit any ostensible and spurious activities. 　　　　　　　　　　　　　　　　　　　 Chapter 2 Quality Control 　　　　　　　　　　　　　　　　　　　 Section 1 Principle Article 5 The enterprise shall establish quality target in accordance with pharmaceutical goods’ quality control requirements, carry out all requirements related to safety, effective and