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厚生労働省医薬食品局監視指導 ・ 麻薬対策課長 ( 公 印 省 略一 )
Contents
1. RES 2 fsa po gt
2. 3 4 10 A 7 5 00 8 6 PQ 1Q 0Q A PQ 8
3. 3 SAL Sterility Assurance Leve1 1 10 4 10 5 1Q Installation Qualification US 6 0Q Operational Qualification 7 PQ Performance Q
4. 35 145 _ 80 2 9 80 2 5 9 12 4 A
5. 2 A _ es 3 _ A
6. 5 5 1 RAT OE A CREAT ORAS EL MEMES SOE 2 PEDERWRO AE ay ene 4 6 1 2 7 1 2
7. vay ite 1 1 QMS 2 QMS HNMR OMIA 3 x0 2 J I
8. WE BEB OL LEWD 12 13 14 5 15 te SOBRE oan EDV 5 4 EARLY AF Ds 1
9. 3 12 1 2 Y HENAN 3
10. PQ 7 IQ 09 PQ 7 10 8 9 11 _ 1 2 _
11. 3 4 8 1 ER NG 9 1 _ en naa ff
12. _ I VD 1 2 27 11 24 3
13. 4 5 _
14. 1218 4 26 12 18 aT ce et amp 16 169 QMS 45 46 17 3 30 0330001 GMP QMS 4 4 TR QMS
15. 3 1 PR JIS T 0801 1 2010 ISO 11135 1 2007 1 2 JIS T 0806 1 2010 ISO 11137 1 2006 1 Bae Cre ae JIS T 0806 2 2014 ISO 11137 2 2013 TSO0 TS 13004 2013 OATES 2 3 eee JIS T 0816 1 2010 ISO 17665 1 2006 1 3 en re eee 2
16. ualification 8 ee 9 _ 10 11
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