" 、『医療機器及び体外診断用医薬品 の製造管理及び品 質管理の基準
Contents
1. QMS 1 2 5 QMS 2 5 IS i 3 1 JIS TO0801 1 2010 ISO 11135 1 20072. 8 9 1 0 1 1 OA A DA NN 1 2
3. 13 1 4 3 NPG EN RFR Ss SN 2 1 2
4. 6 1 2 7 1 2 a AE 3 MMOG I 4 8 RR 1 2
5. 9 1 3 EE 0 or
6. 1 2 3 4 _5 3 4 1 2 5 1 EE IO 3
7. 3 4 5 4 1 2 3 5 5 1 2 3 NOR ER 4
8. 1 2 rrsT oso6 1 2010 rSoO 11137 1 2006 1 JIS T 0806 2 2010 ISO 11137 2 2006 2 3 JIS T 0816 1 2010 ISO 17665 1 20056 1 fY 2 pe A
9. RE 1 3 SAL Sterility Assura SM 1 1 0 n 4 1 0 6 5 IiQ Inst a 1 1 ation Qua 1 ifica tion 6 OQ Operationa1 Qual ificat ion 7 PQ Performance Qu alifieation
10. 0 3 CR st 1 RM 1 2 8 0 1 8 0 1 5 9 2
11. 1 2 3 1 2 1 2 1
12. OQ 1 8 6 PQ Re 1 Q OQ Q 8 a 3 PQ A SS CO AR 2 ORS ENCANA CA 2 10 a 1 8 9 1
13. 2 3 UN HAS ph 3 4 1Q 1 9 5
14. 0 3 3 0 5 2 3 3 3 0 GMP QMS 16 169 45 46 17 3 30 0830001 GMP QMS 4 4
15. 10 5 1 69 _ T SO 1 SO J TS 24 3 31 _ 4 4 4 1 1 1
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