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标题: 加拿大GMP检查风险分级 [打印本页]

作者: godme 时间: 2014-10-15 06:45 PM
标题: 加拿大GMP检查风险分级

TABLE OFCONTENTS目录

1.0 PURPOSE目的........................................................................................................................ 3

2.0 BACKGROUND背景................................................................................................................ 3

3.0 SCOPE范围............................................................................................................................ 3

4.0 DEFINITIONS定义:................................................................................................................ 4

5.0 GUIDE指南正文..................................................................................................................... 6

5.1 Assignment of the riskto an observation针对缺陷界定风险..................................................... 6

5.2 Assignment of theinspection rating检查评定.......................................................................... 7

5.2.1 Risk 1 observation:1类风险缺陷.................................................................................. 7

5.2.2 Risk 2 observation:2类风险缺陷.................................................................................. 7

5.2.3 Risk 3 observations:3类风险缺陷................................................................................ 8

5.3 Additionalguidance补充........................................................................................................ 8

Appendix 1附录1.................................................................................................................................. 9

Appendix 2 附录2................................................................................................................................ 12

Appendix 3附录3................................................................................................................................. 21

作者: 未雨绸缪 时间: 2014-10-16 04:49 PM
谢谢楼主的分享

作者: elsie 时间: 2014-12-3 10:22 AM
感谢楼主无私分享

作者: wangl 时间: 2015-1-23 11:20 AM
谢谢楼主

作者: donglianglyf 时间: 2015-1-23 02:35 PM
谢谢楼主分享

作者: xterra2012 时间: 2019-5-16 10:18 AM
thanks a lot

作者: 错就是错 时间: 2019-6-13 03:34 PM
多谢楼主分享

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