药品质量管理趋势--信息化

来源 :第六届中国医药生物技术论坛 | 被引量 : 0次 | 上传用户：blue1234sky

【摘要】

：

【作者】

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柳俊

【机构】

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武汉爱民制药有限公司

【出处】

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第六届中国医药生物技术论坛

【发表日期】

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2013年1期

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目录新版GMP对计算机系统的要求国外GMP对计算机系统的要求信息化对药品生产质量管理的作用计算机化在国内外的应用情况新版GMP对计算机系统的要求第八章文件管理第一百六十三条如使用电子数据处理系统、照相技术或其它可靠方式记录数据资料,应有所用系统的详细规程;记录的准确性应经过核对.如果使用电子数据处理系统,只有受权人员方可通过计算机输入或更改数据,更改和删除情况应有记录;应使用密码或其它方式来限制数据系统的登录,关键数据输入后,应由他人独立进行复核.用电子方法保存的批记录应采用磁带、缩微胶卷、纸质副本或其它方法进行备份,以确保记录的安全,且数据资料在保存期内应便于查阅.

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药品质量管理趋势--信息化

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