意見募集の結果
Contents
1.2.
3. 5 2 3 Q 3101 5 4 1
4. GMAP5
5. 5 7 OQ
6. gt F
7. A 6 5 7 1 EK
8. DQ IQ OQ PQ
9. 4 1 5 1
10. EY
11. 3 5 1 1 4 5
12. o GQP GQP
13. GMP 0330001 1 1
14. Ne 5
15. Sb No 10 4 1 3
16. G 314I amp A 1 1 Q 1
17. gg 4 4
18. 7 5 GAMP
19. GQP GMP 228l6 7 GMP GGP 6 7 1 4 5
20. I 4 7 5 4 Oo 4 8 Q 4 8 5 5 PQ 1 Q
21. RE 4 4 lt 3 3 4 LNG
22. 4 6 2 4 7
23. 3 3 6
24. H 0 2 5 7 1 3
25. 1 5 4 P 5 4 3 4
26. 7 257H10 GAMP DS DS Design Specification DQ DQ Design Qualification QURS URS User Requirement Specification
27. E 3 4 5 1 1
28. 5 7 5 1 o
29. GAMP 5 FDA General Principles of Software Walidation 2001 1 11 3 1 3 IQ 0Q PQ Q OQ PQ GAMP 5 1IQ OQ PQ I Q OQ PQ
30. 1 1 1 6 6
31. A GMP o IQ OQ PQ
32. rE 1 8 GAMP 4 5 3 4 GA 5 LT
33. 3 3 3
34. _ E ee A 3 A EE
35. DQ IQ OQ P Q DQ 1IQ OQ PQ OO 3
36. LNG 1 1 GQP GMP 2 GVP GCP QMS 4 2 2 1 11 17 3 30 0
37. 4 8 Q amp A 5 4 5 PLC
38. lt 9 6 E
39. 7 3 5 182 OQ
40. 5 6 4or5 X 4 6 4 7
41. 4 4 4 1 3 OQ 3 4 1 3 6
42. Q 320 a Q amp A DCS 4 5 Q I
43. EE 3 6 1 ll ft et 5 5 1 El
44. 3 5 8 i P Q
45. Oo 0 3
46. 7 6 4 8 LNo PL P LC 7 311 Q amp A 7 e
47. SOP PQ SOP 1IQ OGQ CSV GAMP 5
48. 1 GAMP 5 Periodic Review 7 6 7 6 9 6 2 GQP GMP GQP GMP Q amp A
49. 3 4 5 2 GQP GMP G QP GMP 1 1 GMP 5
50. 1 3 URS 3 OQ PQ GMP
51. 5 IC 5 GMP 0 4
52. Periodic review GGP GMP P 5
53. 3 18 9 1
54. 5 5 5 1 1 3 GAMP 5
55. GMP 0330001 4 4
56. ea oii IE GMP OO 9 gg
57. DQ AA DQ 1 Q 1 3 5 2 1
58. 21 21 2 6 2 5
59. DQ 2 DQ DR DQ a A
60. 4 5 4 5 1 4 2 3 4 5 1 4 5 2
61. S 9 5 5 1 GAMP GMP 5 6
62. 5 3 1 6 7
63. OE 0 1 URS User Requirements Specification 3
64. 5 13 4 1 3 gt 4 1 3
65. DQ IQ OQ PGQ 2 5 4 3 5 4 5 5 pa 5 5 i RR ENP
66. Q amp A 331
67. OQ PG OQ PQ 4 5 4 6 4 7 1 0 ri OQ P Q OQ P Q GAMP PQ 4 5 4 6 4 7 PQ
68. 0 2 3 3 1Q 1 Q
69. G QP rm ER ES 0401022 GMP QMS 0330001 2 ER ES 2
70. G P ea RW GOP GMP PT RD 5 10 GQP lt GMP GQP Ne FE
71. RE Mo G25 o 4 OA i A 5 O
72. 4 8 EE FAT SAT 5 6
73. o 4 4 ha 4 2 4 5 1 4 7 2 2 4 E
74. 313l amp A 1 Q GM 315lg A 1 P Q lt Q 317 g A 1 3 2 8 b Q 10
75. 16l1 1 I Q OQ I OQ NIC KA 9 1 GMP GQP 0901004 18 9 1
76. l6 7 6MP fd wn GMP o
77. HPLC 2 CN 2 EE RE 2
78. 3 EN OA JC 5 F S 4 URS URS 5 FS DS 4
79. I I Oo 2 2 10 21 NR 2 2 7 1 6 8 2 0 3 1 3 9 4 3 A hi LNo_ 3ll 2 6
80. 21 1 6 1 7 i i
81. 327l amp A 1 8 E Q 4 A 328I amp A 2 4 lI 3 3
82. GMP IT 2 3 1 4 5 2 4 3
83. OQ PQ 5 6 2 S AT PQ PQ PQ PV
84. What How GAMP 5 3 ER RR GMP
85. RN 5 DQ 1 Q OQ PQ 7
86. ER ES ER ES Q amp A FS D S DQ
87. 2 5 a AA dT 4
88. HPLC GC DQ DQ VMP GAMP G AMP GMP
89. 5 LNo EERE 329 Q 3 o GAMP5 ANNEX 1 1 3 30 ER
90. GMP 1 8 2 i L GQ P GMP GMP
91. GMP 13 27 10 PQ 1 PQ P V P Q 1 CH Q7A ASTM2Z500 PQ PQ PV 5 5 187j PQ PQ DQ 1IQ OQ PQ
92. 4 6 4 7 GQP GMP OQ OQ I Q 1 Q Q i SAT IQ OQ
93. 4 8 FAT SAT er R27 a
94. Ta 3 A Q amp A 4 3
95. FAT S AT 6 5 Fs 5 Fs EN
96. 1 1 1 Q PQ Q 312 amp A 1
97. HE ERT DS 3 GMP GQP 1
98. 1 1 9 Oo 6 2 EE EE O DQ 5 2 DQ
99. LNo ES EE jl6 AO 1 2 6 6 6 6 2 209
100. 1 1 0330001 GQP NSP 3 1 1 1 1 GQP 0
101. FAT SAT FAT 1 Q OQ
102. 0 O ER 1 5 8
103. 2 4 G QP GMP GQP 10 10 GMP GMP
104. 8 GQP GMP 3
105. 8 LNo 219 6 3 6 2 7 II ED 6 2 2
106. GAMP r KS NG MES 1 I 1 Q
107. 3 A i 2 1
108. 5 a 5 6 4 9 HGAMP Verification
109. 5 2 GAMP GAMP 4 GAMP 5 GAMP E 4 E URS URS FS 4 URS 4 3 3
110. 3 4 5 6 3
111. GQP GMP GAMP GAMP 1 1 Ne 2008 GAMP 5 CSV CSV GAMP 5 G AMP 5 GAMP 5 15H1
112. GVP GCP QMS RS GQP GMP GQP GMP GLP GCP G x P G x P 3 PE
113. EE o 5 GAMP 4 4 5
114. 4 1 3 I 4 1 3
115. EXCEL ACCESS 7 PC PC 4 A PC PC
116. o 4 5 1 6 QMS
117. 3 hh CL 5 3 1 5 5 3 16 7 DQ IQ DQ PGQ
118. 9 DQ IQ OQ PQ GMP DQ 1IQ OQ PQ ti i di int E MP
119. g 1 NT ORR IQ OQ 1
120. 21CFR 820 ISO9000 Validation Verification have been filled 1 4 6 7 8
121. DQ 2 GAMP 5 5 URS I 9 4 4 E UR S 74 2 1 1 1
122. 8 GMP GMP ER 1 3 3 a 3
123. 5 4 3 4
124. 2 1 2 Q amp A 1 3 1 1 GAMP 1 1 2 1 3 Tra ckWi s e gt lt
125. DS URS FS DS 3 1 1
126. GAMP GAM P CFR Part 1 1 GAMP ISPE GAMP Annex 1 1 2008 4 GAMP 4 GAMP 5 GAMP GAMP GQP 2
127. 1 Periodic review GMP Self inspection GAMP 4 01 7 1 2
128. 3 2 2 4
129. 2 4 1 Q amp A30 GAMP PICS 6ood Practices For Computerised 4 Systems In Regulated GXP Environments 9 4
130. 3 1 44 GQP GMP Q DR a
131. GQP 4 8 3 De GMP
132. 4 2 lt 4 8 4 2 lt 4 8 2 2 2 G ME GQP GMP Q amp A
133. a 1 P 5 2 Q 5 324W amp A 1 5 3 Q 32 3 5 Q 5 326l amp A 1 5 E Q
134. o TURS FS DS 10 URS FS DS DQ IQ OQ PQ URS FS DS 1 1 FS DS 2 2
135. oqo OoG Operational qual ifleat on QFS FS Functional Specification LIQ iQ Installation Qualification PQ PQ Performance Qualification 258 10 SAT FAT E i 259 10 ems DQ
136. 2 GQP GMP GMP GMP Active Directory GMP
137. 0901004 ge a 4 3 3 4 3 3 1 1 1 4
138. 9 5 1 6 7 6 0 5
139. 1 3 3211 amp A 1 2 2 2 DCS o DCS DCS 322lg A 1 3 4 Q GPG Testing A 323lgA 1 A 8 3 5
140. OQ O Q HPLC i URS OQ
141. gt i ee 3 3 5 7 1
142. OQ 1 GO Q amp A 1 1 2 1
143. P Q OQ PQ PQ SOP 0Q P Q PQ PQ OQ OQ FAT S AT OQ FAT SAT
144. GAMP CFR Part11 ER ES G AMP Annex11 Annex11 2008 4 GS AMP G AMP
145. 6 7 4 4 ww ww re 1 Eg
146. 1 206 210 6 2 6 2 2 gt 21 6 2 6 2 21 3
147. Q 9 HPLC 17 4 1 0401022 Q9 1 1 GA MP 4 GAMP 5 CSV
148. 318H amp A 1 1 T GMP GQ 319 amp _A 1 1 LNo
149. 4 5 PLC URS 5 OQ PQ
150. 330001 GQP GMP GXP KX 9 4 3 5 P 1Q a Fe i Oo
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