PMDAが実施するGMP適合性 調査について

1 11 CPhI China 2009 2 3 20092009 ( ) ( ) GMP 4 GMP GMP/QMS GMP/QMS /QMS/QMS /QMS/QMS 5 6

2 7 8 GMP 9 2007 4 10 (2007 4 GMP/QMS GMP/QMS IV III II II 11 12 13)

3 14 GMP GMP pmda * 15* MRA MOU MRA(M tl RitiAt MRA (Mutual Recognition Agreement: EU MRA MOU Memorandum of Understanding: )MOU Memorandum of Understanding: ) 16 17 20 19 444 1158 52 112 102 214 524 738 812 44 70 3 1 0 1 77 78 33 320000 33 2 34897144222042873915360 34897144222042873915360 839 2201 99 135 122 257 1477 1734 120718 GMP/QMS 2500 GMP 2000 GMP GMP 150010005000 19 20 250 200 91 15043 1001371421 25080 2720 GMP/QMS 78 161 117 170 111 155 100 101 101 149 100 158 88 117 46 142 72 156 29 131 104 161

4 110 157 88 131 59 21 22 23 12 5 1 1 1 5 1 1 5 2 2 1 2 1 17 10 7 1 1 5 2 6 14 16 5 5 51 5 5 1 7 6 5 1 2 1 4 3 54 4 3 54 7 4 4 3 69 1 2 2 1 1 2 2 3 2 2 9 3 1 1 1 1 1 1 1 1 124 8090 846070 57405039203014010 252517 17 20 26 GMP 1% 9% 7% 83% GMP 272727 4550 354045

5 2530 10152005290965542221114993722531 22 19 10 9 6 5 5 4 2 2 2 1 1 1 49 39 23 17 2 2 5 3 12828 29 30 31 17 3 30 17 3 30 0330001 32 33 34 pmda GMP pmda GMP

6 35 2010 2010 2009 363636 pmda 37 ( ( 38 39 40 TEL; + -3-3506-9446 FAX; + 335069465 FAX; + -3-3506-9465 Home page.))