摘要
目的掌握湖北省药品生产企业色谱系统数据可靠性的管理情况,评估其存在的风险。方法通过问卷调查的形式收集药品生产企业在色谱系统数据可靠性方面的基本情况,并分析相关问题。结果调研中发现,该省部分药品生产企业在数据可靠性方面的人员管理、电脑操作系统、仪器工作站设置及文件管理上还存在一定风险,仍需进一步改进。结论掌握了该省药品生产企业色谱系统数据可靠性的管理现状,并分析存在的风险和需要进一步完善的环节,促进企业尽快提高改进满足数据合规性的要求,并为省级药品监管部门对药品生产企业监管提供参考。
Objective To grasp the management status of data reliability of chromatographic system in pharmaceutical manufacturing enterprises in Hubei Province,and to evaluate its existing risks.Methods Collected the basic information of pharmaceutical manufacturers on the reliability of chromatographic system data through questionnaire surveys,and analyzeed related issues.Results The survey found that some pharmaceutical manufacturers in this province still have certain risks in the aspects of data reliability in personnel management,computer operating systems,instrument workstation settings,and file management,and further improvements are still needed.Conclusion We have mastered the current management status of the data reliability of the chromatographic system of pharmaceutical manufacturers in this province,and analyzed the existing risks and links that need to be further improved,and promoted the enterprises to improve as soon as possible to meet the requirements of data compliance,and provide reference for the provincial drug regulatory authorities for the supervision of pharmaceutical manufacturing enterprises.
作者
王松
刘彦安
金菁
董辉
何本霞
黄偲
WANG Song;LIU Yanan;JIN Jing;DONG Hui;HE Benxia;HUANG Cai(Technical Review and Verification Center of Hubei Drug Administration,Wuhan,Hubei Province,430071 China)
出处
《中国卫生产业》
2021年第2期78-82,共5页
China Health Industry
基金
湖北省食品药品监督管理局科研课题:药品行业色谱分析数据系统(CDS)数据可靠性现场核查方法标准化的探索(201801018)。
关键词
数据可靠性
色谱系统
调研
药品生产企业
药品监管
Data reliability
Chromatographic system
Investigation
Drug manufacturing enterprise
Drug supervision
