制造执行系统MES在制药企业的应用

The Application of Manufacturing Execution System for Pharmaceutical Industry

针对制药企业的车间信息化建设比较落后、现场质量管理还依赖人工的现状和问题,以及制造执行系统(MES)在这类企业应用的必要性以在行业内领先的生产企业实施MES系统的场景和经验为基础,阐述了制药企业应用MES系统的核心任务,指出要重点关注工序级别的工艺过管控和质量控制,同时要兼顾工厂级别的系统间集成。探讨了该行业MES系统的基本功能,包括产品定义、生产能力和计划管理等,介绍了该业MES系统的重点,包括配方管理、工艺流程、称重分配和电子批记录等。对在多个制药企业获得的成功应用方法和要点进行了介绍。

Aimed at the current situation and problems of the informatization construction of the pharmaceutical companies,the site quality management reliance on manual labor,and the necessity of the application of manufacturing execution systems(MES) in such enterprises,based on the scene and experience of MES system implementation by leading enterprises in the pharmaceutical industry,the core tasks of the application of MES for pharmaceutical industry were expounded,and it was pointed out that should focus on process control and quality control at the process level,and take into account the system integration at the factory level.The basic functions of the MES system about pharmaceutical industry were discussed,including product definition,production capacity and plan management,etc.And several key points were introduced,including recipe management,process flow,weighing distribution and electronic batch records.The method and main points of successful application in many pharmaceutical companies were exemplified.