薬食監麻発0330第5号:平成23年3月30日
Contents
1. QMS 1 2 QMS 2 IS 3 1 JIST 0801 1 2010 TSO 11135 1 20072. Ei 3
3. 3 4 6 1 7 1 a CO 6 SS 0 1 4
4. 3 2 8 0 1 8 0 1 5
5. 3 SAL Sterility Assura nce Leve 1 1 1 0 n 4 1 0 6 5 EQ Installation Qua 1 ification 6 OQ Operationa1l Qual if icat ion 8 7 PQ Performance Qu alification
6. ce 8 9 1 0 1 1 1 2
7. 12 1 2 1 2 3 4 5 3 4 1 2 5 1
8. 9 1 2 1 gt gt 3 4 5 4 1 2 3 5 5 1 2
9. 1 3 1 4 1 5 4 1 2 i 1 2
10. 8 1 2 9 1 2
11. 2 3
12. 1 2 JIS T0806 1 2010 1ISO 11137 1 20086 1 TIS T0806 2 2010 ISO 11137 2 2006 2 3 JIST 0816 1 2010 SO 17665 1 2006 1 gt 3 1 2
13. 2 2 2 1 0 1 8 9 1 1 1 a a 2 3 1 2
14. 4 1Q i 0 i 5 OQ 1 8 6 PQ 1 I Q OQ PQ 8 3 PQ 7 1 IQ OQ PQ
15. 0 3 30 5 2 3 3 30 5 CMP QMS 16 169 45 46 17 3 30 0330001 GMP QMS 4 4
16. 10 5 1 69 1 SO I SO IS 24 3 31 4 4 4 1 1 1
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