药品制剂生产过程信息化监管研究  

Informatization Supervision in Pharmaceutical Preparation Manufacturing Process

作　　者：曹明 冉薇 吴振生 王晓宇 贺卫萌 孙鹏 CAO Ming;RAN Wei;WU Zhensheng;WANG Xiaoyu;HE Weimeng;SUN Peng(Center for Information,National Medical Products Administration,Beijing 100044,China;Beijing Data Driven Technology Co.,Ltd,Beijing 100102,China)

机构地区：[1]国家药品监督管理局信息中心,北京100044 [2]北京数衍科技有限公司,北京100102

出　　处：《中国医药导刊》2022年第8期754-757,共4页Chinese Journal of Medicinal Guide

摘　　要：药品制剂生产过程信息化监管是通过对药品制剂生产过程中原辅料和中间品的关键质量数据、关键工艺数据、检验数据等药品制剂全生命周期的数据进行采集和质量安全监控,对超标超限的数据进行预警,对关键变更和重大偏差进行跟踪,通过数据分析模型发现和预警药品生产过程中的质量安全风险,有效提高监管部门对药品生产过程监管的效率,维护药品生产质量安全。根据目前我国国情,药品制剂生产过程信息化监管进一步普及和发展还需要依赖于药品制剂生产企业信息化水平的提升,以及相关法律法规和标准的完善。本研究阐述了药品制剂生产过程信息化监管的意义,探讨了药品制剂生产过程信息化监管路径,总结了药品制剂生产过程信息化监管的局限性,以期为提升药品制剂生产过程信息化监管提供参考。The informatization supervision in pharmaceutical preparation manufacturing process collects data in the entire manufacring whole life cycle of pharmacentical preparation,including key quality data,key data in processing,final inspection data of pharmaceutic preparations of raw materials and auxiliary materials and intermediate products,etc,in order to monitor the quality safety,provide early warnings when certain data exceeds the standard limit,and track key changes and major deviations during the process.By analyzing the data models,it is able to find and warn the risks within the manufacturing process,and improve regulation efficiency of regulatory agencies,thus better guarantee the quality and safety of drug manufacturing.According to the national conditions in China,the development and widely use of informaization supervision still depends on the informatization level of the pharmaceutical preparation manufactaring enterprises and the improvement of relevant standards,laws and regulations.This study expounds the significance of informatization supervision of pharmaceutical preparation manufacturing process,analyzes the path of informatization supervision of pharmaceutical preparation manufacturing process,and summarizes the limitations of the informatization supervision of pharmaceutical preparation manufacturing process,in order to provide a reference for improving the informatization supervision of pharmaceutical preparation manufacturing process.

关 键 词：药品制剂生产过程监管 药品制剂质量安全 智慧监管 

分 类 号：R95[医药卫生—药学]