丹红注射液数字制药平台设计与建设

讨论丹红注射液数字化制药平台的设计与建设,建立制药过程数据采集与集成系统,集成原料、生产批次记录、质量检验、设备、人员等数据,实现丹红注射液从原料至成品生产全过程数字化管理。采用数据挖掘技术建立信息智能处理系统对丹红注射液制药过程产生的海量数据进行分析处理,建立丹红注射液统计质量监控模型,确保制药过程质量。将基于实时数据的质量控制与生产管理相结合,规范业务处理流程,实现生产过程高效、节能、环保和安全的全方位闭环管控。

Digital pharmaceutical manufacturing platform design and implementationfor Danhong injection

The design and implementation of digital pharmaceutical manufacturing platform for Danhong injection was discussed in this paper to provide total digital management covering the whole process from raw material to final product. Data collection and integration system was constructed to integrate raw material information, batch records, quality control, equipment status, personnel information. Further intelligent data process system was designed to mine the big data collected from Danhong injection manufacturing process and construct statistical quality control models. Real-time data based quality control and production management was integrated in the platform formalize the business process to provide highly efficient, energy saving, environment friendly and safe quality controland managementwith closed loop.