『薬事法及び採血及び供血あっせん業取締法の離部を改正する法律の
Contents
1. _ 3 4 IQ 1 2 5 3 OQ 1 8 6 PQ 1 1 Q OQ 2 PQ2. 3 SAL Sterility Assura nce Leve1 1 1 0 n 4 10 6 5 ITQ Installation Qua 1iEfication 6 OQ Operational1 Qua1l ification
3. DK DX1 2 SY Nh NN
4. 3 1 2 1 2 1 2 1 2 3
5. 1 2 5 1 3 1 4 1 5 2
6. 8 0 1 8 0 1 5 9 1 2 3 4 5 4 1 2 3
7. 7 PQ Performance Qu alification 8 9 1 0 1 1
8. 4 5 3 F 1 2 5 1 2 3 bE 4
9. 05 3 4 8 1 2 9 1
10. 0 3 30 5 23 3 3 0 CMP QMS a 16 169 45 46 17 3 30 0330001 CMP QMS 4 4
11. 8 5 3 PQ 7 1 1Q OQ P Q 2 1 0 1 8 9 1 1 1 CS 2
12. 5 hm 5 1 2 3 4 6 1 2 7 _ 1 2 RN RS NN
13. 10 5 1 69 1 SO I SO J IS 24 3 31 4 4 4
14. 1 1 1 QMS 1 2 QMS 2 IS 8
15. 1 TIS T0801 1 2010 ISO 11135 1 2007 1 2 JIST 0806 1 2010 TSO 11137 1 2006 1 JIST 0806 2 2010 ISO 11137 2 2006 2 3 JIST 0816 1 2010 ISO 17665 1 2006 1 2
16. 4 1 2 1 2 3 1 2
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