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Good engineering practice (GEP)良好工程质量管理规范，在医药行业是指一个规范化只要工厂所期望的工程建设项目管理体系。 医药工程中，新建、改建、扩建等项目的整个生命周期中，相关人员按照一定的标准实施批准过后的工程管理方法和执行标准，并且备好提供符合成本、工程进度、质量体系、工程范围和规避风险的解决方案，这样做好充分准备，可以将医药工程建设项目因为前期、中期控制导致的问题和隐患在项目初期就得到充分的解决。 良好工程实践的意义何在呢？GEP可以使得整个医药工程项目的全生命周期的项目建议、设计、采购、施工、建造、安装、调试、可行性、验证等过程都能够符合通用的工程规范。总而言之，GEP就是有组织、有纪律、有计划、有目标地完成医药工程建设项目。（四有） 可以说，将GEP作为GMP的补充，是药品生产企业能够最终符合药品质量管理规范的保证和关键。 Good engineering practice (GEP) Good Engineering Quality Management Practice in the pharmaceutical industry refers to a standardized management system for as long as the factory expects an engineering and construction project. In pharmaceutical engineering, in the entire life cycle of new construction, reconstruction, expansion and other projects, the relevant personnel implement the approved project management methods and implementation standards in accordance with certain standards, and are prepared to provide solutions that meet the cost, project schedule, quality system, project scope and risk avoidance, so that full preparation can be made so that the problems and hidden dangers caused by the early and medium-term control of the pharmaceutical engineering construction project can be fully solved at the beginning of the project. What is the point of good engineering practices? GEP enables project proposal, design, procurement, construction, construction, installation, commissioning, feasibility, verification and other processes throughout the life cycle of a pharmaceutical engineering project to meet common engineering specifications. All in all, G EP is an organized, disciplined, planned and targeted completion of medical engineering construction projects. (four haves). It can be said that the GEP as a supplement to the GMP is the guarantee and key to the pharmaceutical manufacturer's ability to finally comply with the drug quality management practices. |
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