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介绍先进的质量管理理念和方法,结合生物制药工程项目质量管理的特殊性,制定乙脑疫苗工程项目质量管理策略和流程,将质量验证管理方法在项目各阶段予以实施,对关键系统进行质量控制和风险管理等,较好地满足了项目质量的需求。通过实践,提供了一种简便、有效、可控的质量管理方法,解决了生物制药工程项目质量管理的问题,取得了良好的成效,对类似工程项目质量管理具有指导和借鉴作用。
Introducing advanced quality management concepts and methods, combining with the particularity of quality management of biopharmaceutical engineering projects, formulating the quality control strategies and procedures of JE vaccine engineering project, implementing the quality verification management methods at all stages of the project, carrying out quality control on key systems And risk management, to better meet the needs of project quality. Through practice, it provides a simple, effective and controllable quality management method to solve the problem of quality management of biopharmaceutical engineering project and achieved good results. It has guidance and reference for the quality management of similar engineering projects.