薬食監麻発0330第5号 平成23年3月30日 各都道府県衛生主管部（局
Contents
1. 2 a2. 3 4 IQ 1 2 5 OQ 1 8 6 PQ 1 1IQ OQ 2 PQ 8
3. 3 SAL Steri1lity Assura nce Leve 1 1 1 0 a 1 0 6 5 IQ Installation Qua 1ification 2 6 OQ Operational Qua l ification 7 PQ Performance Qu alification
4. 3 2 12 1 2 1 2 3 4
5. 5 1 2 3 4 6 1 2 7 1 2 on EAR ON ET
6. NG 8 3 PQ A 7 1 I Q OQ PQ 2 1 0 1 8 9 1 1 1 s 2
7. 8 0 1 5 9 1 2 3 4 5 4 1 2 3 5
8. 4 8 1 2 1 lt FN 2 0
9. 10 5 1 69 I SO I SO IS 24 3 31 4 4 4
10. 1 1 1 QMS 1 2 QMS 2 IS 3 1
11. JIST 0801 1 2010 ISO 11135 1 2007 1 2 JIST 0806 1 2010 ISO 11137 1 2006 1 JIST 0806 2 2010 ISO 11137 2 20006 2 3 JIS TT 0816 1 2010 ISO 17665 1 2006 1 3 1 2
12. 0330 5 23 3 3 0 GMP QMS 16 169 45 46 17 3 30 0330001 GMP QMS 4 4
13. 1 2 1 3 1 4 1 5 DR 4 1
14. 2 1 2 3 1 2 8 0 1
15. RS NT 8 9 2 10 1 1
16. 5 3 DI 4 1 2 5 1 2 PC ER
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