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Title: ICH Q9 Quality Risk Management Author: Dr.-Ing. Stephan R nninger Last modified by: _at_ ( ) Created Date: 8/11/1997 10:42:18 AM – PowerPoint PPT presentation

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Title: II. 3:


1
II. 3??????????????????
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  • ? ?

????
????????????????????????? II.4????????????? II.5
???? II.6?? II.7?????????????? II.8??????
?????????????????????????
2
??????
T. Matsumura, ????
3
II.3?????????QRM
  • ??????????????????
  • ???????????????????????????????(ICH Q8???)
  • ?????????????????
  • ????(????????????????)
  • ???????
  • ??????????

ICH Q9
4
????????????????????????
????????(OOS)??????????????????????????
??
???????
  • ????????????????
  • ???????????????????
  • ??????????

A. Hussain, FDA 2004?9??????
5
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  • ?????????????

A. Hussain, FDA 2004?9??????
6
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  • ????????????????????

A. Hussain, FDA 2004?9??????
7
II.3?????????QRM
  • ??????????
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  • ????
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  • ????
  • ???????????????????????????????????????

ICH Q9
8
II.3?????????QRM
  • ????????????
  • ????????????
  • ???????????
  • ????????????????????????(?????????????????)?????
    ????
  • ??????????????????(ICH Q8???)

ICH Q9
9
???????????CTD P2?
????????????????????
10
????????????????????CTD P2???
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11
Development
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??????????? (?????????????????)
????????? (?????)
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???????
???????
?????
??????????(????? DOE??) (????? 1. ??2. ??)
?????????????????????
????
??
EFPIA PAT TG, 2006
12
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3???????????
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EFPIA PAT TG, 2006
13
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1

EFPIA PAT TG, 2006
14
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B)????
A)???
15
?????????????QRM??????????????????????
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  • ????????? ?????????
  • ????????????????????????????
  • ICH Q9 4????????
  • ??????????????????
  • ??????????????????
  • ?????????????????(???)??????

16
??????
Takayoshi Matsumura, ????
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