「薬事法及び採血及び供血あっせん業取締法の一部を改正する法律の
Contents
1. _ 24 3 31 4 4 4 1 1 12. 1 Sie 2 8 0 1 8 0 1 5 9 1 2 3
3. 16 169 45 46 17 3 30 0330001 GMP QMS 4 4 10 5 1 69 I SO 1 S O IS
4. 9 1 PR 2 25 AA _ 2
5. 6 1 2 7 1 NE AN 3 i 4 8 B 1 2
6. 2 3 1 2 1 2 1 2
7. 1 0 6 TO p 5 IQiInstallation Qua lification 6 OQ Operationa1 Qua 1 if ication 7 PQ Performanoce Qu alification s 8
8. 1 4 _ 1 5 4 2 1 2 3 a
9. 6 PQ _ 1 I Q OQ 92QE 8 AS RE 3 PQ 7 1 ON RE 2 10 DN Ze ON RN 8 9 1 1 1
10. 9 _ 1 0 1 1 i 1 2 CO 1 3
11. 1 2 3 4 5 3 4 1 2 5 1 2 3
12. 4 5 4 1 2 8 5 Se fm 5 1 2 3 4
13. QMS 1 2 QMS 2 6 I 8 3 1 JIS 0801 1 2010 ISO 11135 1 2007 1 2 JIS 0806 1 2010 ISO 11137 1 2006 1
14. Re IS I T SUS 3 4 1Q 1 2 5 OQ 1 8
15. JIST 0806 2 2010 ISO 11137 2 2006 2 3 JIS 08186 1 2010 ISO 17665 1 2006 1 3 1 2 NSR a 3 SAL Steri1ity Assura nce Level 1 1 0 n 4
16. 23 49 2 3 4 8 GMP QMS 024 321 7233 0 3 30 5 2 8 3 3 0 234 4 GMP QMS
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