`厚生労働省医薬食品局監視指導・麻薬対策課長 許薬事法及び採血及び
Contents
1. 2 a 3 4 IQ2. 8 1 2 9 ee atidhehdotoinpg speiahipionigitpbooet dete He is diotcteaod cs 1 todo
3. 10 1 8 9 1 1 1 8 Ce Aa 3 1 2 _ 12
4. _ 5 iQ Installation Qua ification oR 6 OQ Operational Qual fication 7 PQ Performance Qu al if icat ion 0 8
5. ka e v MO
6. FN I SO I SO IS 6 24 3 31 Li 3 4 4 4 1 1 1 MMP
7. 1 J 2 3 4 EE oO 6 1 2 7 1 Moe a MP 3 _ 4 lt
8. 40 ii ris te sr a eg ITP 8 0 50 1 1 rr roger ee io 1 3 2 yu EN RE 4
9. 0 3 3 0 5 23 3 3 0 GMPZQMS 16 169 45 46 RR 17 3 30 0330001 CMP QMS 4 4 Race
10. 1 2 2 609 2 be 3 1 2
11. hr Mae his QMS 1 2 QMS 2 1 8 3 1 JIS T 0801 1 2010 ISO 11135 1 2007 1 2 a JiS T 0806 1 2010 ISO 11137 1 2006 1
12. JIS T0806 2 2010 ISO 11137 2 2006 2 3 J ISTIOE1 6 N20 LOCLSD 17665 1 2006 1 EN 3 1 2 3 SAL Steri1lity As SE nce Level 1 1 0 n 4
13. 1 4 _ 2 2 5 OQ J 1 8 6 PQ 1 1 Q OQ 2 PQ 8 pn _ ER 3 PQ Mr PA rp CC 7 1 1Q OG PQ 2
14. 1 2 1 2 3 4 5 3 4 1 2 5 1 4 MEOW OT MO DED ee 3
15. 8 0 1 8 0 1 _ 5 9 1 2 3 2 4 5 4 1 2 3 5
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