China Will Release a New Version of GMP     

On August 27th, 2009 Mr. Mao Zhenbin, an officer of the Drug Safety Supervision Department of China's State Food and Drug Administration (SFDA), said at a press conference that China will soon enact a new version of "Good Manufacturing Practice" (GMP) to ensure the quality safety of the National Essential Drugs. In the future, when enterprises manufacture drugs in the national essential drugs category, they shall abide by the new-version GMP standards.    
    Mao said that the new-version GMP will use the current-version GMP as its main framework. Eight appendices such as sterile pharmaceuticals, drugs technical, biological products, blood products, Chinese traditional medicine preparations, Chinese herbal medicines, medical gases and radiopharmaceuticals will be added in. It will also include new chapters about quality management, customized production and commissioned testing. The chapter about sanitation in the 1998 version of GMP will be split and placed into other chapters, such as "Institutions and Personnel" and "Plant Equipment and Facilities", and will be described in more details in the new version. The title of the chapter, "Quality Management", in the old-version will be changed to "Quality Control and Quality Assurance" in the new version. And the chapter about complaints and adverse reactions of drugs in the old version will also be transferred to the "Quality Control and Quality Assurance" chapter in the new version.
   In the aspect of concrete contents, the new-version GMP will have new contents about authorized persons for quality, quality risk management, product quality analysis, sustained stability examination plans and the audit and approval of suppliers. It also adds new contents about alteration control, deviation handling, investigation on excess, corrective and preventive measures, and so on.
    The new-version GMP will introduce the content of the international advanced GMP. China's GMP tightly follows the GMP standards recommended by the WHO and also refers to the United States and the European Union standards.