国际医药行业推行的GMP(药品生产管理规范)是我国的制药企业进行药品生产必须通过的认证。针对药品生产企业实施GMP的需要,提出了支持本体表示技术的面向GMP的生产工作流管理系统。以工作流技术为核心.管理复杂的药品生产过程。对于记录药品质量检测和生产操作信息的表格式的生产记录,采用基于本体表示的技术.建立树型结构模型,并提供录入和检索功能。同时,设计了系统模型,并分析了系统各个部分的实现方法。最后.通过一个GMP流程的实现实例对系统的设计方法、实现思路作出了具体的介绍。
The GMP (Good Manufacturing Practice), defined and acknowledged by the international medicine industry, is a series of standards that can be applied to strictly control the quality of the production processes of the medicine enterprise. All the medicine enterprises must get the authentication of GMP in China. In order to implement the GMP in medicine enterprises, a production process management system for GMP is proposed in the paper. The system is built based on workflow, which is applied to model and control the production process. The ontology technology is also adopted to record the information relating to the medicine production and inspection. The workflow model and ontology model for GMP are defined. The system structure, and the important parts of the system are introduced in the paper. A case study is also presented.