滅菌バリデーション基準の制定について
Contents
1.2. 35 145 80 2 9 re ee 5 9
3. 16 4 1 2 Le 3
4. 10 11 12 13 14 15
5. 2 BAREORE Y HGAYS 3 WERE 4 5 IT F 7
6. 5 00 8 6 PO IQ 0Q 1 PQ 8 PQ 7 7 1Q 0Q PQ HES REONRILOVCBAL RBS IE
7. 4 6 1 2 7 1 2 wi 3 WEROWANLIER OREREICONT MESES LCOS 4 3 1
8. 2 SAS A HOGAN 3 4 10
9. 12 7 4 7 5 5 1 BEA 2 3
10. 4 4 BAU Fy ay Be QMS 1 VD sn 261219 KE ELL zu
11. 2 27 11 24 3 1 1 QMS 2
12. 2 9 1 A
13. IQ Installation Qualification 6 0Q Operational Qualification 7 PQ Performance Qualification 8 9
14. QMS 2 IS 3 1 JIS T 0801 1 2010 ISO 11135 1 2007 1 2 JIS T 0806 1 2010 ISO 11137 1 2006 1 JIS T 0806 2 2014 ISO 11137 2 2013 IS0 TS 13004 2013 2 3 WARE JIS T 0816 1 2010 ISO 17665 1
15. 10 8 9 11 1 Se 2 3 A 12 1
16. 2006 1 3 1 2 BROVEREMBOS TEED BETTER IE WRK 3 SAL Sterility Assurance Level 1 10 4 10 5
17. 26 6813 27 1 1 6 HER Ca ED iB REF 024 521 7233 1218 4 26 12 18 RR Fi 4 mo 16 169 QMS 45 46 17 3 0 0330001 GMP QMS
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