薬食監麻発0330第5号
Contents
1. 0 0W _ RN _ 2 a2. 2 8 0 1 8 0 1 5 9 1 2 3 4 5 4 6 1 2
3. NN 3 4 1 Q Eo OM 2 5 OQ 1 8 6 PQ 1 I Q OQ ES 2 PQ 8 Ni 3 P Q
4. Ms a 4 8 1 A MN 9 Di
5. 1 2 _ 12 a i nd a 1 2 _3 4 NO i 3 YO 4 a 1 2 5
6. BA 2 A i RE 2 0 ED A i a 1 2 QMS 2 1 S 3 i EST 0801 1 2010 ISO TI TI GE 1 Ur nr 2 7 JIS T 0806 1 2010 ISO 11137 1 2006 1 JiS TO
7. 1 5 _ i 2 2 _ 1 _ 2 gt 3 EE _ 1
8. 10 5 1 69 1 SO I SO J IS _ 24 3 31 4 4 4 1 1 1
9. 1 RD 3
10. 3 5 _ 5 1 2 NN Do 4 IS 6 1 2 7 1 2 EE
11. 0 3 3 0 5 2 3 3 3 0 _ GMP QMS 16 169 45 46 17 3 30 0330001 _ GMP QMS _ 4 4
12. 1 0 6 5 _ es Instal tion Qua 1 ificat ion 6 OQ Operational Qual ification 7 PQ Performance Qu alification a 3 8
13. 9 NR 1 1 _ _ 2 EE 1 3 lt 1 4 _
14. 7 1 1 Q OG P Q 2 10 1 8 9 1 1 1 1 2 _ 3
15. 806 2 2010 ISO 11187 2 2006 2 3 rrs T 0816 1 2010 TSO EN 1 1 2 RR EO OR 3 SAL Sterili ty As sura nce Level 1 1 0 n 0
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