摘要
针对制药行业存在的较高的法规和技术门槛,提出了一种适应行业特点的MES产品设计与实现方法。分析了制药行业MES产品应满足的关键需求,包括生产环节的完整覆盖、法规、灵活性、确认及验证等,并针对这些需求,设计了多层次的系统架构。介绍了实现的工厂模型、产品配方、计划和工单等软件模块功能,以及配套的相关验证文档模板,并对产品应用情况进行了分析。采用这种方法设计实现的MES产品,能够覆盖整个制造过程,具有较强的灵活性,符合法规要求,实施成本低,能满足制药行业管控要求。
Aiming at the high regulations and technical barriers in the pharmaceutical industry,a method of MES product design and implementation that adapts to the characteristics of the industry was proposed.The key requirements of MES products in pharmaceutical industry were analyzed,including complete coverage of production process,laws and regulations,flexibility,qualification and validation,etc.,and the multi-level system architecture was designed for these requirements.The software module functions of factory model,product formula,plan and work order,etc.,as well as the supporting validation document templates were introduced,and the application of the product was analyzed.MES products designed and implemented by the method can cover the whole manufacturing process,have strong flexibility,meet the regulatory requirements,with low implementation cost,and can meet the control requirements of the pharmaceutical industry.
作者
梁永宏
张昊
黄康培
谢霞
LIANG Yonghong;ZHANG Hao;HUANG Kangpei;XIE Xia(Guangzhou CH Control Technology Co.,Ltd.,Guangzhou 510070,China)
出处
《机电工程技术》
2020年第7期166-168,共3页
Mechanical & Electrical Engineering Technology
基金
广州市产业技术重大攻关计划项目(编号:201802010003)。
关键词
制造执行系统
制药行业
MES
manufacturing execution system
pharmaceutical industry
MES
