第53号(平成27年9月24日発行)
Contents
1. OQbD QbD 142. SOP ISO IEC 51 GAMP5 FMEA URL http eCompliance cojp SHOP 151113P html 11712 FDA CAPA 2
3. 4 1 PIC S GMP Annex11 PIC S GMP Annex11 2013 1 1 4 2 ICH Q8 Annex 15 ICH Q8 Quality by Design QbD IPAT Process Analytical Technology 4 3 ICH Q9
4. 2015 10 26 10 30 16 30 5F 1 48 600 46 170 2 1 1 24 300 2 2 IEC62304 Medical device so
5. URL https cartO shopservejp ecompliance coJp newmem php http eCompliance cojp GMP 10 23 2 co Jp SHOP C151 0 02 Q amp A
6. 6 ET gt Cw NS Estimated 60 OP ss global market Size of illicit goods based on public sources Cocaine Totak 1 trillion Value in billion Cigarette smuggling Human trafficking 30 Environmental crimes and 20 natural resources trade Logging 5 Art and cultural artifacts 5 Small arms 1 2 Black Market
7. 2015 12 7 10 30 16 30 6 5F 3 0 46 170 1 27 http eCompliance co jp B160137 html 2016 1 27 13 00 16 30 KRI SN 4F 2 43 200
8. Ee 1
9. 2014 6 1 PIC S GDP 2014 5 19 PIC S GDP Good Distribution Practice 2014 6 1 PIC S Guide to Good Distribution Practice GDP for Medicinal Products PIC S GDP 2013 EU GDP EU GDP EU EEA PIC S GDP PIC S 1 GDP GDP
10. 1 20GB EN 24 http eCompliance coJjp TEL 03 5461 9538 FAX 03 5460 0955
11. QbD Quality by Design 50 Pr ES OQ PQ agete N IQ oo mg Frere ET 3 FS N URS 4 PIC S GMP Annex15 i GMP Annex15 1 PIC S GMP Annex11 Q8 3 ICH 09 4 ICH 010 RN 6 QWP 7
12. i 2015 10 22 10 30 16 30 4F 1 48 600 46 170 http eCompliance coJp RR http eCompliance co jp 20 10 28 http eCompliance co PP 028 html
13. QMS QMS QMS QMS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 1 18 19
14. 3
15. 1 1 30 http eCompliance co jp SHOP B151140 html Re 2015 11 30 10 00 17 00 48 600 46 170 3F 3F 4 10729 19 http eCompliance co jp SHOP B151029 html
16. Site Acceptance Testing SAT 3 gt OM CAPA Perma Document FDA CAPA
17. 6 1 Cold Chain counterfeit falsifed medicine PIC S 2014 6 1
18. ICH Q9 4 4 Annex15 4 5 facilites Systems Equipment Processes Utility Annex15
19. 1 QMS EAMES 2 2 NH 3 4 5 _ 6 1 QMS QMS
20. 2 tv ya 2015 10 23 10 30 16 30 C amp J 5F 2 48 600 46 170 CAPA 10 29 OB hi CAPA RCA CAPA SOP CAPA CAPA CAPA CAPA SOP 2015 10 29 10 15 16 45
21. FMEA 1 General Principles of Software Validation CPSV 2 IEC62304 GPSV 3 IEC62304 6 URL
22. 2015 10 20 10 30 16 30 3 i NE 1 48 600 46 170 10721 http co jp SHOP B151021 html 2015 10 21 10 30 16 30 PiO 6F C 48 600 46 170 10 22 http eCompliance co jp SHOP B151042 html
23. http eCompliance co jp 0 http eCompliance coJp 2 1 2 1 ES amp amp E mail amp
24. CSV ER ES ER ES CSV CAMP 5 CSV IT IT 4 CSV MS Bxcel CSV ER ES FDA
25. Meister 1345 16 30 2 CMC 11 18 http eCompliance co RE 8 CNT PEDOT etc 2015 11 18 10 30 16 30 3F 3F 4 48 600 46 170
26. CSV ER ES CSV ER ES CSV ER ES CAMP 5 1 1 4 2 5 3 URL http eCompliance cojp SHOP 151215P html 12 14 amp ER ES 2 URL 2 64 800 61 560 2
27. SOP PQ PV DQ Design Qualification Factory Acceptance Testing FAT Acceptance FAT
28. 16 20 17 00 3 18 Ni 10 30 http eCompliance co jp C151014 html CTD 2015 10 30 13 00 16 30 43 200 41 040
29. 2015 10 28 10 30 16 30 1 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 10 29 http eCompliance co jp A151039 html
30. CAPA Excel Word CAPA FDA CAPA 21 CFR Part 1 1 CAPA CAPA CAPA FDA CAPA CAPA CAPA
31. 9 V Model 10 PV CSV 1 2 ER ES 11 6 CSV 1 2 ER ES URL http eCompliance cojp SHOP 151026P html 10 16 2 URL 2 64 800 61 560 2 1 1 32 400 gt http eCompliance cojjp SHOP 151026 27P html 5 10 16 CSV amp ER ES 2 1 CSV
32. Excel CSV ER ES Z 7 CAMP 8 9 V Model 10 PV CSV 1 2 ER ES 11 6 CSV 1 2 ER ES URL http eCompliance cojp SHOP 151214P html 12 15 2 URL 2 64 800 61 560 2 1 1 32 400 gt http eCompliance cojp SHOP
33. EU EU 1990 GDP Good Distribution Practice 2013 3 PIC S EU GDP 2014 6 1 CDP GDP EU GDP EU PIC S GDP 2008
34. 4 48 600 46 170 10 26 http eCompliance co jp C151009 html 2015 10 26 10 30 16 30 5F 1 54 000 51 300 1030 1300 1
35. RY 1987 6 FDA 1987 General Principles of Software Validation GPSV GPSV IEC62304 FDA General Principles of Software Validadon FDA IRC62304 IEC 82304 EC 80001 ISO 1497 1
36. 10 00 POQ Annex15 FAT SAT 10 0Q 1IO0Q 00 PO 00 PO PQ PV Process Validation Testing SAT 4 7 Annex15
37. 81 GDP PIC S a 15 2015 10 1 EU GMP Annex 15 Annex 15 GDP PIC S GDP 1 GDP 4 GDP 2 GDP 5 EU GDP Q amp A 3 PIC S GMP Annex 15 6 PIC S GDP
38. PiO 6FC Ch PIC S FDA 11 11 Data Integrity PIC S FDA http eCompliance co jp C151175 html PIC S FDA i PIC S US Annex 11 PIC S CMP 3 DO Annex 11 Annex 11 EMA Q amp A a 2015 11 11 10 30 16 30
39. 4F 48 600 46 170 11 25 http eCompliance co jp B151175 html 2015 11 25 13 00 16 30 5F 4 43 200 41040 a 31 a 11 26 http eCompliance co jp B151176 html
40. 2 2014 11 25 23 2 23 2 3
41. 2015 10 29 10 00 17 00 48 600 46 170 5F 4 10 30 http eCompliance co jp SHOP B151040 html i 2015 10 30 10 30 16 30 6 5F 4 8 600 46 170 10 20 http eCompliance co jp SHOP B151060 html
42. PV PQ PV el ZS URS 1 wn ee a a http eCompliance co jp Perma Ne nt 8 HW Find us on Facebook FacebooK Facebook Facebook https www facebook com ecompl ref bookmarks amp ER ES 10 15 2 1
43. 1 1 4 2 5 3 URL http eCompliance cojp SHOP 151027P html 10 15 amp ER ES 2 URL 2 64 800 61 560 2 1 1 32 400 gt http eCompliance cojp SHOP 151026 27P html http eCompliance coJp ma http eCompliance c
44. HH 21 PL 11 11 PL http eCompliance co jp C151173 html PL RO EU RT DN Ds MA ED PA 9 j 2015 1 1 13 00 16 30 4 43 200 41 040 11719 http eCompliance co jp B151119 html etc 1 2015 11 19 10 30 16 30
45. FS Functional Specification 2 DQ Design Qualification DQ DO Design Qualification PIC S
46. 140 0004 3 4 1 1201 03 5461 9538 0 E mail info eCompliance co jp Presentation URL http eCompliance co jp
47. 4 6 Qualifcation Annex15 Qualification DQ IQ 00 PQ URS FAT Factory Acceptance Test SAT Site Acceptance Test IOQ 0Q PO 0Q DQ IQ 0Q PQ 4 Annex15 FAT SAT FAT
48. Annex 15 ICH Q9 ICH Q9 ICH Q9
49. URL 2 64 800 61 560 2 1 1 32 400 gt http eCompliance co jp SHOP 151112 13P html QMS QMS 12 3 QMS QMS 2 1 QMS QMS QMS OMS 2015 12 3 10 30 16 30 4F 48 600 46 170 2 1 1 24 300 2
50. 2 2015 10 29 10 30 16 30 3F 4 48 600 46 170 10 20 OS EA CO UI 2015 10 20 13 00 16 30 6F 43 200 41 040 10 23 http eCompliance co jp B151063 html
51. 19 2015 10 23 10 30 16 30 48 600 46 170 10 29 http eCompliance co jp C151006 html NE NE 2015 10 29 10 30 16 30 0 2 5F 1 48 600 46 170
52. 2 Cold Chain counterfeit falsifed medicine EU Black Market 200Billion 2 2010 WHO GDP 2
53. DO 3 NN
54. IS0 13485 FDA DIS Draft International Standard QMS ISO 13485 QMS QMS QMS QMS QMS 1 4 ISO 13485 2 5 QMS QMS 3 QMS URL gt http eCompliance cojp SHOP 151203P html 10
55. SAT FAT SAT IQ PV URS 1 ee OQ DQ le FAT eele i SAT 4 00 IQ 0Q 1IOQ IQ 0Q IOQ PQ 00
56. 0Q10 GMP Al 2015 10 29 10 15 16 45 Bl 2015 10 30 10 30 16 30 PiO GF D 64 800 61 560 GMP SO PIC S PIC S GMP 10 30 http eCompliance co jp SHOP C151001 html PIC S GMP GMP PIC S GMP 2015 10 30 13 00 16 30 5F 3 43 200 41 040
57. PO TT PO 00 PQ 00 PO PQ 0OQ URS
58. CSV ER ES 2015 10 16 10 30 16 30 4F 2 48 600 46 170 2 1 1 24 300 2 2 CSV CSV ER ES CSV ER ES CSV ER ES CSV ER ES CAMP 5
59. URL gt http eCompliance cojp SHOP 151204P html 11 amp ER ES 12 14 2 1 CSV ER ES CSV GAMP ER ES IQ0Q PQ SOP Excel CSV ER ES CSV ER ES 2015 12 14 10 30 16 30 48 600 46 170 2 1 1 24 300 2 2
60. ICH Q9 IS0 14971 FDA 28 1 2 RIMap 3 4 B5 100 5 6 7 8 http eCompliance cojp SHOP P102 html 140 4 3 4 1 1201 Rl
61. 17 4 RE QUALIFICATION 5
62. QMS QMS QMS GOP QMS QMS QMS QMS QMS QMS QMS IS0 13485 2003
63. 20 21 22 23 GVP MS Word 2007 MS Excel 2007 23 FDA ICH 09 IS0 14971 FDA FDA
64. CMC 103D 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 Q3D 14 15 16 15 2 ICHQ3D
65. GDP GMP GDP 1 30 GDP URS PQ FS Ei lt u OQ X
66. gt http eCompliance coJjp SHOP 151026 1P html FDA CAPA 11 12 FDA CAPA 2 1 FDA CAPA 7 CAPA CAPA 2015 11 12 10 30 16 30 5F 4 48 600 46 170 2 1 1 24 300 2 2 CAPA
67. 41 040 22 QMS QMS 2014 11 25 GOP QMS II QMS
68. 1030 12 15 1 CDP PIC S 1300 1500 2 GDP PIC S 15 15 1700 3 GDP VMP 12 4 http eCompliance co jp SHOP P151232a html PIC S VMP GMP
69. GAMP 5 CSV IT IT 4 CSV MS Excel CSV ER ES FDA Exce CSV ER ES 7 GAMP 8
70. 2015 11 26 10 30 16 30 5F 1 48 600 46 170 11 30 http eCompliance co jp C151102 html 2015 11 30 10 30 16 30 MSc MOT 4F 48 600 46 170 1277 http eCompliance co jp B151287 html
71. CAPA 7 CAPA URL http eCompliance co jp SHOP 151112P html 117 13 2 URL 2 64 800 61 560 2 1 1 32 400 gt http eCompliance cojp SHOP 151112 13P html 11 13 SOP 2 1 ICH Q9 IS0 14971
72. CMP ISO PiO 6FD 48 600 46 170 16 010 GMP IS0 9001 10 30 ISO 9001 2015 9 http eCompliance co jp SHOP C151012 html ISO 9001 2015 ISO GMP GMP IS0 9001 ISO 9001 Q10 GMP 2015 10 30 10 30 16 30 GMP ISO PiO 6F D 48 600 46 170 3 1179 http eCompliance co jp SHOP P151131a html GMP
73. CSV ER ES CSV GAMP ER ES IO 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 CSV ER ES ER ES CSV
74. FDA CAPA CAPA FDA CAPA 1 CAPA CAPA CAPA CAPA SOP CAPA CAPA
75. GDP Good Distribution Practice PIC S GDP EU GDP 7 8 9 3 PIC S Annex 15
76. GDP 12 4 0 2 1 GDP GDP PIC S GDP 2015 12 4 10 30 16 30 4F 48 600 46 170 2 1 1 24 300 2 2 GMP
77. 1 1 32 400 gt http eCompliance cojp SHOP 151214 15P html http eCompliance coJp a http eCompliance co jp 5 UAT User Acceptance Test
78. 2015 12 4 13 00 16 30 CMP 5F 1 A Gis RI PIC S 12 15 http eCompliance co jp SHOP P151233a html GMP 2015 12 15 13 00 16 30 GMP 4F 1 43 200 41 040 PIC S 1 27 http eCompliance co jp SHOP P160134a html URS DQ GMP 2016 1 27 13 00 16 30 GMP 4F 1 43 200
79. 151214 15P html 12 12 15 CSV amp ER ES 2 1 CSV CSV ER ES 2015 12 15 10 30 16 30 5F 1 48 600 46 170 2 1 1 24 300 2 2 CSV CSV ER ES
80. 41 040 CAPA amp IS0 9001 010 GMP IO0029W 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 ISO GMP GMP ISO 9001 ISO 9001
81. pa IQ FAT 1 GDP WHO WHO Good Distribution Practice for Human Use Good Storage amp Shipping Practices GSP EU Guideline on Good Distribution Practice for Human Use Good Distribution Practice GDP Good Wholesaling Practice GWP Good Supply Practice GSP JCGSP Japanese Good Supplying Practice GDP OTC GDP JGSP GDP
82. 1 9 PIC S GMP Annex15 1 1 2001 9 PIC S GMP Annex15 2015 PIC S GMP Annex15 2 N NN VMP 0 1 2 H 2 2015 PIC S GMP Annex15 Annex 15 11
83. A 4 MRA 27 9 24 5B gt Annex15 P1 P3 P 13 Ea P14 CSV Part1 1 P14 P 15 2015 10 1 Annex 15 1 Annex15 2014 2 6 EU GMP Annex15 Qualification and Validation 90 2014 9 2015 3 EU GMP Annex15 2015 10 1 EU GMP PIC S GMP EU 4 1 PIC S GMP Annex15 PIC S GMP Annex15 EU GMP Annex15 2015 10 1 2 PIC S GMP Annex15 PIC S GMP Annex15 2001 9 200
84. PIC S CMP EU Anx15 FDA GMP 2015 11 9 13 00 16 30 CMP BIF KCD 43 200 41 040 GDP PIC S 11716 http eCompliance co jp SHOP C151103 html GDP 2015 11 16 10 30 17 00 4F 54 000 51 300
85. SOP 2015 11 13 10 30 16 30 5F 4 48 600 46 170 2 1 1 24 300 2 2 90 10S 14971 2005 ICH 09
86. ftware Software life cycle processes FDA General Principles of Software Validation IEC62304 IEC62304 IEC62304 _ a IEC62304 2014 11
87. oJp 10726 2 1 IEC62304 FDA IEC 62304 FDA IS0 14971 FDA QMS
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