453KB
Contents
1.2. 1 2 8 0 1 8 0 1 5 9 1 2
3. SH 3 4 1 Q 1 5
4. QMS 1 2 QMS 2 IS 1 JIST 0801 1 2010 ISO 11135 1 2007 1 2
5. 8 9 1 0 1 1 1 2
6. 1 SO I SO IS 24 3 31 4 4 4 1 1 1
7. 9 1 2
8. 1 3 1 4 1 5 Ne i 2 1 2 _ 3
9. 6 1 2 7 1 2 9 2 2 3 4 8 1 2
10. ROSS 4 5 4 1 2 3 5 5 1 2 3 4
11. 8 9 1 1 1 2 3 1 2 1 2 1
12. 3 SAL Steri1 ity Assura nce Leyve1 1 1 0 n 4 1 0 6 5 1IQ Installation Qua 1ification 6 OQ Operational Qual ification 7 PQ Performance Qu alification
13. 0 3 3 0 5 2 3 3 3 0 GMP QMS 16 169 45 46 17 3 30 0330001 GMP QMS 4 4 10 5 1 69
14. OQ 1 8 6 PQ 1 1 Q OQ 2 PQ 8 3 PQ 7 1 OQ PQ 2 OE 2 1 0 1
15. JIS T0806 1 2010 SO 11137 1 2006 1 JIS TO0806 2 2010 ISO 11137 2 2006 2 3 JIS T 0816 1 2010 ISO 17665 1 2006 1 3 1 2
16. 2 1 2 3 4 5 3 4 1 2 5 1 2 3
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