Ⅰ．製造基準 - 日本核医学会
Contents
1. PET2. 2 PET 1 2 3
3. PET lt gt 6 1 6 PET 2
4. PET GMP
5. PET Certifcate of Analysis
6. 2 3 4 5 Co
7. HPLC PET HPLC
8. 1 2 3 lt gt 7 1 3 7 1 4 7 1 6
9. PET PBT PET
10. LS
11. 7 4 1 Hu
12. i 4 PBT 5 12 12 1 PET PET PT
13. 1 PET 2 3 4 5 7 8
14. 1 2 PET 3 1 4 5 6 PET SOP
15. LH B 0 2
16. PET
17. PET PET
18. 8 10 5 4 6 PET 6 1 PET PET PET 6 1 1 PET 6 1 2 PET
19. 7 PET 7 1 PET PET PET 7 1 1 PET 7 1 2 7 1 3 PET 7 1 4 6 1 11 PET
20. E N 13 PET HT
21. 1 2 3 4 5 3 PET GMP 4 PET
22. 2 4 8 4 PBT PET
23. 3 2 3 4 5 6 1
24. GMP 8 7 PET
25. 3 GC HPLC 6 5 5 PET 1
26. lt gt 7 1 10 PET PET HPLC GC 3
27. pH PET PET gt E PET
28. Guidance PBT Drugs Current Good Manufacturing Practice CGMP lt ICHQ2A PET 3 F 1
29. ul 16 16 1 PET 16 1 1 PET 16 1 2 16 1 3 5
30. MCA Nal Ge L MCA PET
31. PET
32. IQ OQ Operational Qualifcation OQ HPLC RI OQ k
33. 3 PET PBT
34. m lt gt 7 1 5 lt gt 7 1 7 PET PET m
35. 10 1 1 10 1 2 10 1 3 PET lt gt 10 PET
36. Q7 GMP TS RY 3 kl 11 11 1 PET 11 1 1 11 1 2 11 1 2 1 PET 11 1 2 2 11 1 2 1
37. 7 1 10 7 1 11 7 1 11 1 7 1 11 2 7 1 11 3 7 1 12 lt gt 7 1 1 7 1 2 PBET
38. PET Eo E
39. 5 5 1 PET PET PET 5 2 PET PET PET PET 5 3 PET PET PET 5 4 PET 5 1 5 3 PET
40. 2 PET PET 1 2 3 4 3
41. PBT 1 2 3 4 PET PET PET PET
42. 1 PET d 2 3
43. 12 1 1 12 1 2 12 1 3 12 1 2 12 2 PET 12 1 3 lt gt 12 PET 1
44. PET E E
45. 7 7 1
46. T NT us mn 17 PET 17 1 PET GMP 36 2 PET 17 2 PET PET 32 167 lt gt 17 PET
47. 1 1 PET 1 2 3 3 4 TLC ITLC
48. E gt 9 1 1 N i ICH 4 1 PET
49. 11 1 2 3 11 1 2 2 11 2 PET 11 1 2 3 gt 11 00 1 2 PET 3
50. PET PET N 13 PET pH PET
51. lt gt 7 1 11 1 2 3 4 5 6 7
52. 8 1 1 8 1 2 8 1 3 PET 8 1 4 8 1 5 8 2 PET 11 1 3 gt 8 1 2 3
53. lt gt 6 1 5 P BT P 1 1 2 3 4 ET PET HH 2 PET PET PET A H
54. 1 HEPA 6 PET HEPA 2 3 lt gt 6 1 11PE
55. 3 E lt gt 6 1 7 PET
56. 9 10 11 PET 10 8 lt gt 6 1 4 1
57. 16 5 13 13 1 PET PET PET 13 1 1 13 1 2 PET 13 1 3 PET lt gt 13
58. 8 2 6 1 5 3 PET
59. GMP 0709002 GMP GMP 0330001 FDA PET Drugs Current Good Manufacturing Practice CGMP PET PET GMP GMP PET GMP GMP PET FDA
60. 3 E 1 PET 3 PET v E 0 9 BL 5 PET
61. PET PET 1 PET 2 3 PET 4 PET 5 6 7 8 PET PET
62. PET 1 1 PET 2 PET PET 2 1 PET PET PET PET PET PET 2 2 PET PET lt gt PET PET PET PET PET
63. k 0O 18 F 18 F FDG IR NMR E PET fi
64. PET 1 6 PET 1 7 1 8 PET lt
65. 2 PET PET
66. 3 Operational Qualification OQ PET OQ 4 Performance Qualifcation PQ PET 3 PQ PQ
67. PET GMP PET PET 1 PBT lt gt PET PET 1 PE
68. g FE E PET
69. PET GMP 4 PET 4 1 PET PET PET PET 4 2 4 1 PET PET lt gt PET 7 4 PET
70. 3 2 PET PET PET PET lt gt PET
71. 706 PET E E 3
72. E FDG PET 2 E PET 1 PET FDA GMP GMP RADIOISOTOPES Vol 59 No 9 2010
73. 2 PET PET PET 1 PET y PET
74. 7 1 5 PET PET PET PET 7 1 6 PET 7 1 7 PET PET 7 1 8 PET 1 7 1 9
75. 6 7 PET GMP 18 4 ul 15 15 1 PET 15 1 1 PET 15 1 2 PET 15 1 3 gt 15 PET
76. lt gt 6 1 8 1 Design Qualification DQ PET 2 Installation Qualifcation IQ
77. PET 6 1 3 PET 6 1 4 PET 6 1 5 PET 6 1 6 6 1 7 6 1 8 6 1 9 6 1 10 P
78. MBq ml 7 PET PET F 18 FDG pH PET 1 PET F
79. PET 5 4 1 PET 5 4 2 5 4 3 5 4 4 5 4 5 5 4 6 5 4 7 5 4 8 5 4 9 5 4 10 5 5 PET PET PET PET PET PET lt gt 5 1 3
80. 1 E PET cGMP for PET drug PET PET 5276 HH PET PET PET PET
81. 4 PET PET 5 PET 9 9 1 PET 9 1 1 9 1 2 PET
82. lt gt 16 1 2 3 4 5 6 7 1 1 PET 2 3 PET 5 PET
83. 4 PBT 1 2 3 4 34 E
84. 8 9 10 1 2 3 4 5 SOP 6 7 8 8 1 PET
85. 9 2 PET 9 1 1 gt 9 1 PET PET 3 PET
86. lt gt 6 1 9 PET H lt gt 6 1 10
87. 14 14 1 PET 14 1 1 PET PET 14 1 2 14 1 3 14 2 PET 17 1 1 gt 14 GMP 1 2 3 4 5
88. PET GMP 0709002 o GMP PET 17 f ml Pra EX
89. lt gt PET PET GMP PET 1 1 1 PET PET 1 2 PET 1 3 PET 1 4 PET 1 5 PET
90. 1 lt gt 7 1 9 1 Design Qualifcation DQ PET HPLC 2 Installation Qualification IQ
91. lt gt 7 1 8 3 PET E 3 PET PET PET 2
92. 18 FDG 1 PET N 13 O 15 gt 6 1 3 PET
93. 8 FDG F 18 FDG PET E E FDA Guidance PET Drugs Current Good Manufacturing Practice CGMP GMP 12 10 uk 10 10 1 PET
94. ET 6 1 11 PET 6 1 12 6 2 PET lt gt 6 1 1 PET
95. I 3 FDG PET PET E PBT PET PET PET
96. T PET 2 3 4 PET 5 ub 3 PET 3 1 PET PET PET PET
97. T PET PET PET PET CU RY lt gt 6 1 12 gt 6 2 PET PET
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