医院制剂中心生产管理系统建设的探索与实践

Exploration and practice on the construction of production management system in hospital preparation center

医院制剂生产有着严格的生产工艺流程,从原辅料、中间品到最终上市的制剂,都要求记录批号、数量、重量、时间、人员、设备参数、偏差等相关数据,这是保证制剂质量的根本依据。本文以首都医科大学附属北京世纪坛医院(以下简称“我院”)制剂中心为例,在医疗机构制剂配制管理规程的基础上,建设了一套完整制剂生产管理系统,并应用于控制我院制剂维生素E乳膏的生产过程中。通过生产管理系统中的信息化手段,有效整合制剂生产各个环节中的数据并完整记录,有效地解决了溯源问题,最终实现了制剂生产的全过程管理,保证了制剂质量。

Hospital preparation production has a strict production process,from raw materials,intermediate products to the final preparation on the market are required to record the batch number,quantity,weight,time,personnel,equipment parameters,deviations,and other related data,which is the fundamental basis for ensuring the preparation quality.In this paper,taking Preparation Center of Beijing Shijitan Hospital,Capital Medical University(“our hospital”for short)as an example,a complete preparation production management system is established on the basis of the management procedures of preparation in medical institutions,and is applied to control the production process of preparation vitamin E cream in our hospital.Through the information means in the production management system,the data in each link of preparation production was effectively integrated and completely recorded,which effectively solved the problem of traceability,and finally realized the whole process management of preparation production and guarantees the quality of preparation.