| 新形势下药品GMP认证检查管理信息系统建设探讨 |
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| 引用本文： | 樊晓东. 新形势下药品GMP认证检查管理信息系统建设探讨[J]. 中国药房, 2010, 0(1): 12-14 |
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| 作者姓名： | 樊晓东 |
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| 作者单位： | 国家食品药品监督管理局药品认证管理中心; |
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| 摘 要： | 目的:提出构建新的《药品生产质量管理规范》(GMP)认证检查管理信息系统的建设思路,以满足新形势下GMP认证检查工作的需求。方法:围绕新形势下药品GMP认证检查工作的目标与任务,对建设一个全新的药品GMP认证检查管理信息系统的目标、总体框架、结构和数据库内容等进行分析和探讨。结果与结论:随着信息化技术的迅猛发展和药品监管形势的变化,建立新的药品GMP认证检查管理信息系统是保障药品检查工作的效率和质量,实现科学监管的当务之急。
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| 关 键 词： | 药品GMP认证 信息化 认证检查 管理信息系统 |
Construction of Drug GMP Certification Inspection Management Information System in the New Situation |
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| FAN Xiao-dong. Construction of Drug GMP Certification Inspection Management Information System in the New Situation[J]. China Pharmacy, 2010, 0(1): 12-14 |
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| Authors: | FAN Xiao-dong |
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| Affiliation: | FAN Xiao-dong(Center for Certification of Drug,State Food , Drug Administration,Beijing 100061,China) |
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| Abstract: | OBJECTIVE:To put forward the ideas on construction of a new drug GMP certification inspection management information system to meet work needs in the new situation.METHODS:The purpose,overall frame,structure and database of new system were analyzed,considering the goal and task of drug GMP certification inspection.RESULTS&CONCLUSIONS:With the rapid development of information technology and drug administration,it is urgent to realize scientific supervision through establishing a new drug GMP certification in... |
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| Keywords: | Drug GMP certification Informationzation Certification inspection Management information system |
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