PDF：720KB
Contents
1. 2 0 32. QMS 1 2 QMS 2 IS 3 1 JIS T 0801 1 2010 ISO 11135 1 2007 1
3. 3
4. 8 9 10 1 1 1 2
5. 8 1 2 9 1 _
6. 3 1 8 0 1 8 0 1 5
7. 3 4 6 1 2 7 1 2 3 4
8. 9 1 2 2 3 4 5 4 1 2 3 5 5 1 2
9. 13 1 4 1 5 D8 4 1 2 1 2
10. 12 1 2 ER 1 2 3 4 5 3 4 1 2 5 1 2
11. 3 SAL Sterility Assura nce Leve1 1 1 0 n 4 1 0 6 5 IQ Installation Qua 1ification 6 OQ Operational Qual if ication 7 PQ Performance Qu alification
12. 4 IQ 1 5 OQ 1 8 6 PQ 1 1 Q OQ 2 PQ 8 ON ON 7 1 OQ
13. 2 JIS T 0806 1 2010 ISO 11137 1 2006 1 JIS T 0806 2 2010 ISO 11137 2 2006 2 3 JIS 0816 1 2010 ISO 17665 1 2006 1 3 1 2 2
14. 69 1 SO I SO IS 24 3 31 4 4 4 1 1 1
15. 0330 5 2 3 3 3 0 GMP QMS 16 169 45 46 17 3 30 0330001 GMP QMS 4 4 10 5 1
16. PQ NR Rr 2 10 1 8 9 11 1 2 3 1 2
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