| GMP体系下Windows操作系统合规性探索 |
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| 引用本文： | 胡顺,郑莹,刘泽伦,邓宇,安定国,蒋琼霞. GMP体系下Windows操作系统合规性探索[J]. 中国药业, 2020, 0(4): 18-21 |
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| 作者姓名： | 胡顺 郑莹 刘泽伦 邓宇 安定国 蒋琼霞 |
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| 作者单位： | 湖北省食品药品监督管理局东湖新技术开发区分局;武汉华龙生物制药有限公司 |
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| 摘 要： | 目的为提升药品生产企业数据可靠性管理水平提供参考。方法分析药品生产企业执行药品生产质量管理规范(GMP)及相关法规过程中在计算机化系统常用操作平台(以Windows 7系统为例)管控上存在的问题及其可能原因,并提出了可操作性的解决方案。结果与结论GMP体系中Windows操作平台在数据可靠性及合规性上存在一定的问题,药品生产企业应引起重视,需通过适当措施进行必要的管控,以减少药品数据在其生命周期内的风险。
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| 关 键 词： | 药品生产质量管理规范 药品数据 可靠性 合规性 WINDOWS操作系统 WINDOWS7 |
Exploration of Windows Operation System in GMP Compliance |
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| HU Shun,ZHENG Ying,LIU Zelun,DENG Yu,AN Dingguo,Jiang Qiongxia. Exploration of Windows Operation System in GMP Compliance[J]. China Pharmaceuticals, 2020, 0(4): 18-21 |
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| Authors: | HU Shun ZHENG Ying LIU Zelun DENG Yu AN Dingguo Jiang Qiongxia |
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| Affiliation: | (East Lake New Technology Development Zone Branch,Hubei Food and Drug Administration,Wuhan,Hubei,China 430075;WuhanHualong Biopharmaceutical Co.,Ltd.,Wuhan,Hubei,China 430043) |
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| Abstract: | Objective To provide reference for improving the level of data reliability management of pharmaceutical manufacturers.Methods:By analyzing the problems and possible causes of the management and control of the common computer operating system(taking Windows 7 as an example)in the process of implementing Good Manufacturing Practice(GMP)and related regulations by pharmaceutical manufacturers,the operability solution was proposed.Results&Conclusion There are certain problems in the reliability and compliance of the Windows operating platform in the GMP system.Drug manufacturers should pay attention to this and need to adopt appropriate control measures to reduce the risk of drug data over its life cycle. |
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| Keywords: | Good Manufacturing Practice drug data reliability compliance Windows operating system Windows 7 |
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