良好工程实践(Good Engineering Practice,GEP)是以保证产品质量、患者安全、药品生产质量管理规范(Good Manufacturing Practice of Medical Products,GMP)为目的,专用于制药工程项目的实践.本文基于长春生物制品研究所有限责任公司(简称长春所)现有管理体系及生物制药工程与国际工程项目管理模式,结合GEP技术特点,从用户需求(User Requirement Specification,URS)、计划、设计、变更、质量、移交等关键控制点入手,总结长春所GEP体系建设及其在狂犬病疫苗工程项目中的应用,为疫苗工程项目在风险管理、组织和控制、成本管理及创新和持续改进方面提供技术支持与理论依据.
Application of Good Engineering Practice in rabies vaccine engineering projects
Good Engineering Practice(GEP)is an engineering practice specifically designed for pharmaceutical engineering projects,aimed at ensuring product quality,patient safety,and Good Manufacturing Practice of Medical Products(GMP).Based on the existing management system,biopharmaceutical engineering,and international engineering project manage-ment models of Changchun Institute of Biological Products Co.,Ltd.(referred to as CCIBP),as well as combined with the characteristics of GEP technology,this paper summarizes the construction of GEP system of CCIBP and its application in ra-bies vaccine engineering projects starting with the key control points such as User Requirement Specification(URS),plan,design,change,quality,and handover,so as to provide technical support and theoretical references for vaccine engineering projects in risk management,organization and control,cost management,innovation and continuous improvement.
Good Engineering Practice(GEP)Biopharmaceutical engineeringRisk managementOrganization and con-trolCost managementInnovation and continuous improvement
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