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2010版药品GMP较1998版药品GMP,新增《委托生产与委托检验》章节,对药品生产企业委托生产与委托检验的管理提出更加具体的要求。但是,部分药品生产企业在实施2010版药品GMP过程中,相应管理不符合这些条款的要求。本研究依据2010版药品GMP第十一章《委托生产与委托检验》,参考《药品GMP指南(质量管理体系)》,从委托方、受托方、合同的管理共3个方面,分析了药品生产企业在委托生产与委托检验管理方面存在的常见问题,并针对部分问题提出建议,以期企业能重视委托生产与委托检验行为,严格按照药品GMP的要求对委托生产与委托检验进行管理。
2010 version of the drug GMP 1998 version of the drug GMP, the new “commissioned by the production and commission test” chapter, the pharmaceutical production enterprises entrusted with the commissioning of production management and management put forward more specific requirements. However, some drug manufacturers in the implementation of the 2010 version of the drug GMP, the corresponding management does not meet the requirements of these terms. Based on Chapter 11, “Commissioned Production and Commissioning Inspection” of GMP in 2010 edition and reference to “GMP Guidelines for Pharmaceutical Products (Quality Management System)”, this study analyzed the production of pharmaceuticals in three aspects: the entrusting party, the entrusted party and the contract management Enterprises in commissioned by the production and commissioning inspection management problems, and some of the issues put forward proposals, in order to enterprises can pay attention to commissioned the production and commissioned the inspection, in strict accordance with the requirements of the drug GMP commissioned by the production and commissioned management.