医療機器の製造販売後安全管理に係る安全管理業務(GVP)手順書 第一
Contents
1. 8 3 1 2 ONGEN OM 9 9 1 9 1 12. 2 5 2 6 QMS 72 QMS EE 3
3. GE 2 2 23 2 6 03 3816 3450 FAX 03 3818 8920 18
4. 3 3 2 3 2 1 3 2 2 1 2 GVP 9 3 3
5. 3 4 114 49 2 1 2
6. 2 7 2 8 Pe 3 3 1 114 249 1 2
7. 5 4 2 2 6 4 3 4 3 1 1 2 3 4 4 3 2
8. 3 4 5 9 1 3 1 2
9. 7 7 1 1 2 7 1 1 3 7 1 1 4 7 1 1 5 7 1 1 6 7 2 1 7 1 1 1 7 1 1 6
10. 1 3 US 5 5 1 5 2 QMS 72 2 6 GVP
11. 11 3 3 1 2 12 12 1 12 1 1 12 1 2 1 3 3
12. 3 9 3 2 RO PO 10 10 1 10 1 1 1 2 10 1 2 1 10
13. 0 11 5 3 1 GVP ONS 5 4 2 5 5
14. 2 6 3 1 8 12 2 7 7 1 gnc 2 7 1 1 1 7 1 1 1
15. Mc 1 URL http www mhlw gojp PMDA http www pmda gojjp http www info pmda gojp index html http www info pmda gojjp kaisyuu menu_kiki html http www maff gojp nval _ 1 JIRA http jira net orjp index htm 5 http wwwJjfmda grjp index html JEITA http wwwjeita or jp http homejeita orjp is index html Food and Drug Administration
16. OR OR WE re OSI 1 2 2 1 2 2 2 3 2 4
17. 2 Oo 10 1 3 1 2 10 2 10 2 1 10 2 2 10 3 10 3 1
18. 2 3 8 8 1 8 1 1 1 2 8 1 2
19. 10 3 2 1 2 11 11 1 11 1 1 1 2 11 1 2 1
20. eee 16 17 1 eee 17 23 2 2 135 GVP
21. 68 10 228 20 2 8 1 3 8 1 4 8 2
22. 15 16 17 18 19 20 21 12 1 4 12 2 12 2 1 1 2 12 2 2 1 5 5 2
23. 5 5 6 6 lt 7 7 8 8 0E 6 RCC 9 10 3 6 09909MD093808BRIDBSO8RSRSSUB5B8S3HBBBBR3S93SHRBOSSSBSRBSEBHSSBBREBBHORSs 10 11 11 12 12 1 NARTYSRYSRRRSRTSSEERSStSSSSeaSay 13 14 1 GVP 14 15 2 2 ERANNN 16 3
24. 10 i 30 3 114 55 1 15 12 2 3 13 2014 11 25 13 1 GVP EE GVP 14 2 I 1
25. 2 11 11 2 1 2 11 3 11 3 1 1 2 11 3 2
26. GVP 9 1 4 5 4 4 1 4 1 1 1 2 3 1 1 GVP 4 1 2 2
27. 4 2 1 2 3 4 2 1 1 3 2 3 3 4
28. 1 2 3 4 5 9 1 2 1 2
29. 5 6 1 2 3 6 6 1 1 2 6 2 1
30. 9 1 4 9 2 _ 228 20 2 9 3 9 3 1 1 2
31. 12 1 3 3 3 12 OT RO SN 7 3 8 9 10 11 12 13 14
32. A 15 3 YYYY MM DD DF E 4 YYYY MM YYYY MM DD E
33. FDA http www fda gov http www fda gov Safety Recalls EnforcementReports default htm Medicines and Health products Regulatory Agency MHRA http www mhra gov uk index htm http www mhra gov uk Safetyinformation Safetywarningsalertsandrecalls fieldsafetyn otices index htm Therapeutic Goods Administration TGA http www tga gov au Health Canada http www hc sc gc ca index eng php http www healthycanadians gc ca recall alert rappe avis index eng php 17 Ver 2014 11 14 HP 2014 11 19 01 gt 1 2 6 1 1 1 0 112 0004 GE
34. LIRA GVP gt JIRA IRA 2014 11 2 Rev 01 ES 3 MP ODPM 0 3 2 06 SO 3 3 uuu 4 4
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