Transcription of 原薬製造所に対するGMP調査と問題点 - nihs.go.jp
1 GMP GMP GMP GMP GMP GMP GMP/QMS /QMS /QMS GMP/QMS II III II IV PMDA GMP GMP GMP GMP GMP PMDA * *
2 1 B: C: D: D D) 1130004 17 11 30 D) 15 15 GMP GMP GMP 80237804338118 83919981752246102144702105 3481021100912111151006 30000003 448483101085 44489366023391142551011 83934834444419 8989298171123082281016 29154753314685495 13300001 365049101042 57032923297247323478 (100%) (1%)
3 (22%) (2%) (38%) (37%) 75 63 9 17 9 6 7 4 4 4 2 1 1 1 1 1 1 2 4 3 13 16 2 1 1 2 1 17 4 20 12 9% 1% 7% 83% GMP GMP 0510152025 9 4 5 6 16 4 27 14 19 14 3 GMP
4 GMP GMP GMP MF MF MF CMC GMP 17 3 31 GMP ( Science non-Science non-Science 2 GQP 1)
5 PMDA GMP PMDA GMP PMDA GMP GMP MF GMP GMP TEL.
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