第52号(平成27年8月27日発行)
Contents
1. SOP 7 1 7 2 8 3 ISO IEC 51 9 4 1 0 CAMP5 5 1 1 FMEA 62. 4 5 R Map 1 R Map R Map 2008 4
3. 60 EDA COPO 1 5
4. 14 2008 CAMP 5 GAMP 4 GAMP Guide for Validation of Automated oystems GAMP 5 TA Risk Based Approach to Compliant GxP Computerized Systems Annex15 ICH OQ8 QbD Quality by Design FDA
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8. combination of the probability of occurrence of harm and the Severity of that harm ISO IEC Guide 51 2
9. QMS J OMS QMS GOQP QMS QMS QMS ee 6 OMS QMS
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11. 2015 10 23 10 30 16 30 48 600 46 170 10 29 http eCompliance co jpC151006 html 7 2015 10 29 10 30 16 30 2
12. FDA SOP CC CC 9 24 FDA http eCompliance co jp SHOP 150924P html http eCompliance co jp http eCompliance co jp 2 1 OCC 5 2
13. QSR Part1 1 Notes FDA Notes Part11 Part1 1 KW FDA Part1 1 Part1 1 Data Integrity Data Integrity
14. 9710 2 1 FDA COPQ 2015 9 10 10 30 16 30 4F 48 600 46 170 2 1 1 24 300 2 2 FDA
15. DICE QSR 21 CFR Part 11 21 CFR Part 11 21 CFR Part 820
16. 2015 10 28 10 30 16 30 5F 1 48 600 46 170 10 30 http eCompliance co jp B151050 html 2015 10 30 10 30 16 30 48 600 46 170 _ FPC 11711 loT
17. CSV ER ES ER ES CSV GAMP 5 1 IT IT 4 CSV MS Excel CSV ER ES EDA
18. a 0 N Annex15 PIC S GMP Annex11 2013 1 1 2013 1 1 1
19. 2 1 a 2 2 2 2 24
20. FDA FDA EDMS Notes CSV Part1 1 FDA 483 Warning Letter CSV CSV Partl 1 GxP Part11
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22. 2015 9 30 13 00 16 30 4F 43 200 41 040 U WL 10 16 http a co jp B151056 html 2015 10 16 10 30 16 30 4F 48 600 46 170 _ 10 20 http eCompliance co jp B151056 html
23. 4 UE 5 6 1 QMS QMS QMS QMS
24. CAPA FDA CAPA CAPA FDA CAPA 1 CAPA CAPA CAPA CAPA SOP
25. 25 4 373 13 9 RE 6
26. FDA 2014 10 FDA FDA 21 CFR FDA FDA FDA FDA Form483 1 9 2 FDA 1 0
27. SO IEC Guide 51 1 J htt i eCompliance c63p 2 2
28. FDA FDA FDA FDA FDA 704 EDA Form 483 FDA Form 483
29. QMS QMS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 GVP
30. 8 3 1 2 3 6 2 3 4 4 7
31. CSV Part1 1 CSV 2 FDA CDRH Center for Devices and Radiological Health FDA 6 CDRH DICE Food amp Drug Administration s Division of Industry and Consumer Education FDA DICE 2 DICE pdf Notes
32. http eCompliance co jp GMP 10 23 i lleCompliance co TTY AA j RS Es A i CE Q amp A 2015 10 23 10 30 16 30 C amp J 5F 2 48 600 46 170 GMP
33. 10 16 CSV amp ER ES 2 1 CSV CSV ER ES 2015 10 16 10030 16 30 4F 2 48 600 46 170 2 1 1 24 300 2 2 CSV CSV ER ES
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37. R Map R Map 5 5 R Map 5 1 R Map R Map A3 A2 A1 B3 B2 B1 C 6 10 10 10 10 6 10 10 7 10 7 lt 103 I 0 I IV 6 R Map A B C 3 A B C
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40. Pl1l P4 2 P 1 4 CSV Part1 1 P14 P 15 1 FDA FDA 1 1 2
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42. Part1 1 2003 9 2004 FDA EDMS Notes FDA Notes Part1 1 Part11 Part1 1 FDA
43. 1 7 CAPA 2 EFDA 8 CAPA 3 CAPA 9 CAPA 4 1 0 5 1 1 CAPA 7 6 1 2 CAPA URL http eCompliance co jp SHOP 151112P html 11 13 2 URL 2 64 800 61 560 2 1 1 32 400 gt http eCompliance co jp SHOP 151112 13P html 11 11 13 SOP
44. _ 2 GMP
45. QC OOS Out of Specification Part11 Warning Letter 2001 10 14 1 0 2002 Part1 1 2 500 EDA
46. 5F 1 48 600 46 170 CAPA amp IS0 9001 010 GMP 2 10 29 30 http eCompliance co jp P151040 html A CAPA 10 29 CAPA lt RCA gt CAPA SOP CAPA CAPA CAPA CAPA SOP B ISO 9001 010 GMP 10 30 ISO 9001 2015 IISO CMP GMP TSO 9001 ISO 9001
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48. MS Word 2007 MS Excel 2007 23 FDA ICH Q9 IS0 14971 FDA FDA ICH 09 1S0 14971 FDA B5 i 100
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50. http eCompliance co jp SHOP 151203P html 13 A PIC S GMP Annex 15 Qualification and Validation 2015 10 2013 1 1 Annex11 Annex13 ICH 08 09 010 2011 FDA Qualification GMP lg o
51. 2 1 ICH Q9 IS0 14971 SOP 2015 11 13 10 30 16 30 5F 4 48 600 46 170 2 1 1 24 300 2 2 90 IOS 14971 2005 ICH 09
52. URL URL 2 Perma Document _ Good Regulatory Platform nttp eCompliance CoJD Perma Document 0 0 SaaS HW The printed name of sjgner Prim Notot Find us on Facebook FacebooK Facebook Facebook https www facebook com ecompl ref bookmarks
53. kh rg CAPA OU Document FDA CSV Part1 1 CAPA gt et _ 5
54. CAPA CAPA CAPA Excel Word CAPA FDA CAPA 21 CFR Part 11 CAPA CAPA 9906 3 wl pm
55. URL gt http eCompliance co jp SHOP 150925P html amp ER ES 10 15 2 1 CSV ER ES CSV GAMP ER ES 1Q 0Q PQ SOP Excel CSV ER ES CSV ER ES 2015 10 15 10 30 16 30 4F 2 48 600 46 170 2 1 1 24 300 2 2
56. FDA FDA FDA Form 483 FDA Form483 2015 9 24 10 30 16 30 5F 48 600 46 170 2 1 1 24 300 2 2 FDA FDA FDA
57. 2 12 4 http eCompliance co jp SHOP P151232a html PIC S VMP GMP 2015 12 4 13 00 16 30 GMP 5F 1 43 200 41 040 16 PIC S _PIC S GMP 10 30 http eCompliance co jp SHOP C151001 html PIC S GMP GMP PIC S GMP 20
58. 2015 8 28 32 400 amp 30 780 1 2 R Map 3 4 5 6 7 8 http eCompliance co jp SHOP P102 html 140 0004 3 4 1 1201 1 Gs
59. http eCompliance co jp B151151 html F PC PC 2015 11 11 10 30 16 30 4F 48 600 46 170 9 10 http eCompliance co jp B150940 html NIN 1 ED 2015 9 10 13 00 16 30 3 4F 1 43 200 41 040 20 _
60. 9 000 2014 1 283 2 706 8 FDA COPQ Cost Of Poor Quality COPO
61. ExceD CSV ER ES 1 7 2 CAMP 8 3 9 V Model 4 10 5 PV CSV 1 2 ER ES 11 6 CSV 1 2 ER ES URL gt http eCompliance coJp SHOP 151026P html 10 16 2 URL 2 64 800 i 560 2 1 1 32 400 http eCompliance co jp SHOP 151026 27P html
62. PAT Process Analytical Technology ICH 09 Annex 15 PIC S GMP Annex 15 Annex11 13 0 Annex1 1 Annex13 ICH 08 0Q9 0Q10 Annex15 PIC S GMP Annex11 Annex13 ICH 08 09 010 URL http eCompliance co jp SHOP 150925P html CSV Part11 9 26 1 Ce FDA a pdf
63. 48 600 46 170 2 1 1 24 300 2 2 2014 11 25 23 2 23 2 3
64. 1 E mail amp URL https cartO shopserve jp ecompliance co jD newmem php
65. QMS 2014 11 25 GOP OQMS QMS QMS ja QMS 1 QMS SI es 2 3
66. 3 FDA 1 1 4 FDA 1 2 GeMP 5 W L 1 3 FDA CAPA 6 1 4 FDA 7 1 5 Appendix 8 FDA URL gt http eCompliance co jp SHOP 150924P html 7 PIC S GMP Annex 15 Annex11 13 Q 9 25 2 1 EU GMP Annex 15 CSV Annex11 Annex13 ICH 0Q8 0Q9 010 011 Annex15
67. 46 170 ICH 03D 10 15 http eCompliance co jp C151011 html 2015 10 15 10 30 17 00 3F 2 48 600 46 170 1030 1400 1 ICH 03D 14 15 16 15
68. PiO 6FC 48 600 46 170 10 29 19 http eCompliance co jp SHOP B151029 html 2015 10 29 10 00 17 00 48 600 46 170 5F 4 10 30 http eCompliance co jp SHOP B151040 html
69. 2015 9 9 13 00 16 30 4F 43 200 41 040 PK 9730 In silico CL Vdss http eCompliance co jp C150913 html CL Vdss IVIVE 2015 9 30 10 30 16 30 4F 1 48 600
70. Excel 9 18 http leCompliance co jp C150912 html DCF Excel Excel 2015 9 18 12 30 16 30 NY 7 43 200 41 040
71. EU 1990 GDP Good Distribution Practice 2013 3 PIC S EU GDP 2014 6 1 GDP GDP EU CDP EU PIC S GDP 2008 81 aR GDP
72. QMS OMS ISO0 13485 2003 ISO 13485 EDA DIS Draft International Standard QMS IS0 13485 OQMS QMS OMS OMS QMS 1 4 ISO 13485 2 5 QMS QMS 3 QMS URL
73. 2 FDA 6 3 COPO 7 CAPA 4 URL gt http eCompliance co jp SHOP 150910P html 5 GDP 9711 2 1 GDP GDP PIC S GDP 2015 9 11 10 30 16 30 5F 48 600 46 170 2 1 1 24 300 2
74. 2015 9 25 10 30 16 30 5F 48 600 46 170 2 1 1 24 300 2 2 PIC S GMP Annex 15 Oualification and Validation 2015 10 2013 1 1 Annex11 Annex13 ICH 08 09 010 Annex15 2011 EFDA
75. Annex13 Annex15 ICH OQ8 QbD Quality by Design FDA PAT Process Analytical Technology ICH 09 A 4 Annex15 FDA 2003 Annex15 PIC S GMP Annex11 Annex13 ICH 08 Q9 0Q10 1 7 2 Annex 15 8 ICH 010 3 9 PIC S GMP Annex 11 4 10 PIC S GMP Annex 13 5 ICH OS ObD 1 1 ANNEX 15 6 ICH 09 _
76. PIC S GMP Annex 15 2015 10 1 EU GMP Annex 15 Annex 15 Nm 0 GDP PIC S GDP 1 GDP 4 GDP 2 GDP 5 EU GDP O0 amp A 3 PIC S GMP Annex 15 6 PIC S GDP URL gt http eCompliance co jp SHOP 150911P html FDA 9 24 2 1
77. 10 26 10 30 16 30 5F 1 54 000 51 300 1030 1300 1 Meister 13 45 16 30 2 CMC 9 4 http eCompliance co jp SHOP B150904 html
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83. 6 http eCompliance co jp SHOP B150916 html 2015 9 16 13 00 16 30 PiO 6F C 43 200 41 040 S P E 9 30 http eCompliance co jp SHOP A150930 html SPE 2015 9 30 10 30 16 30
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