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薬食監麻発0330第5号

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Contents

1. _ 2 MR AL pth J A 3
2. QMS 1 2 ie QMS 2 I 8 3 1 JIST 0801 1 2010 IS0 111835 1 2007 1 _ 2 ST OR CTE OO WSO TET OO
3. 1 2 1 2 0 2 1 2 3 4 5 3 4 1 2 5 1
4. 2 8 0 1 8 8 0 1 RR Oe 9 1 2 1 3 4 5 4 1 2 3
5. 2 1 10 1 8 9 _ 1 1 1 2 3 NZ MS 2
6. 4 1 Q 1 2 iR OWRD 6 a Cu 5 A 1 8 2 6 PQ 1 1 Q OQ 2 PQ 8 2 3 PQ 7 1 I Q O G P Q
7. 3 4 EE 8 1 2 9 1 OO RN 6 8 WM 9 ER ROMEER OR MR OR
8. 5 RE 5 1 _ 1 2 3 4 6 1 2 7 1 2 a 2 OO
9. 1 5 1 69 1 SO 1I SO 1 8 0 I uk Ci AO 4 1 1 1
10. 2 3
11. AO 1 5 6 4 1 2 1 2 a A DAR RR A et 1
12. eerie RC 1 eit 0330 5 2 3 3 3 0 a a 3 1 II ES i rt GMP QMS 16 169 45 46 17 3 30 0330001 GMP QMS 4 4
13. 8 9 1 0 CC NC 11 1 2 1 3 Me 1 4
14. 1 JIST 0806 2 2010 ISO 11137 2 2006 2 3 ITTF OTE LEGOLO TSO 1L7665 gt 2006 1 3 1 f E 2 3 SAL Sterility I AM B
15. 1 1 0n 4 1 0 6 5 io Installati on Qua 1ification 6 OQ Operational Qual ification UN 7 PQ Performanece Oi alification _

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