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cGMP 1, ¥ ñ
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, 2010 ''... 'ο '
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۸ ڣ
ֱ 1 Ѵ ڱ cGMP(current Good Manufacturing PracticeǾǰ ǰ) ϰų cGMP ؿ ̵ϴµ ѷ ϰ ִ.
̴ ΰ 7 Ǿǰ, 2009 ϹǾǰ, 2010ʹ Ǿǰ cGMP Ű 㰡 ʴ ƿ ȼ ߱ ̴.
Ϻ ̷ ħ ο ݹϰ cGMP 뼼 ƹ Ǹ ʰ ִ.
̱ FDA κ Ǿǰ 㰡 cGMP Ǵ ̿ ϴ (EU-GMP ) ʼ 䱸ϰ ־ ߵ Ǿǰ ؿܽ ؼ cGMP Ű Ȯ ʼ̱ ̴.
, cGMP Ȱ
18 ȸ cGMP ڷῡ cGMP ؿ ų ̵ ϴ 48 Ÿ. ̵ 簡 cGMP ϴ 143562300 Ѵ.
ȭ â ϰ cGMP ߴµ 2100 鿩 ߿ ڸ ߰, ߿ 忡 1400, ȭ 400 1800 Ÿ.
̾ ѹ̾ǰ İ, 忡 1200, 400 1600 cGMP ߰ Ѿ 2006 â Ǹ 1325 ƴ.
ȭǰ 1300 鿩 11 ϰ ǰ ۴ 2015 1100 鿩 cGMP ذ ִ. ൵ 1160 鿩 ִ.
̿ܿ ȱǰ, , αǰ, dz, ȭ ʾ 鿩 , , ִ Ÿ.
5 ڴ cGMP ̹ 迡 뼼 ؿܷ ϱ ؼ EU-GMP FDA , cGMP ؿ ƿ ü Ȳ̶ .
, '2010 cGMP '
ѱǻ 10 ѹ FTA ġ ȡ̶ ڷḦ ǰǾǰû 2010 ܰ躰 Ǿǰ ǰ(GMP) ϰ GMP ȣ ̱ Ŵ ɼ ִ١ мߴ.
2006 ѹ FTA Ǿǰо ̽ ؼ ߽, ȸ ƾ Ѵ١ ̱ ȭ Ȯ ƾ Ѵ١ ϰ ִ.
cGMP ٶ ȭ, , GMP , ̱ FTA ȭ ް ִ١ ̿ ȭӿ ܱ ȸ ľ ̸ ȭ ִ ãƾ Ѵ١ ֹ ̴.
̷ 8 ǻ ǾǰGMP ȭ ºм å ̶ Ÿ.
ڷῡ 2010 GMP ȭǸ ǰ Ǿǰ ټ ȭǰ ũ þ ̶ Ѵ.
縦 GMPȭ 84.1% 纸 þ ̶ ߴٰ ߴ.
Ը 1000 ̻ 91.9% ȴٰ ݸ 50 100 ü 9% ̶ .
, "cGMP ...ο "
cGMP ؿ ƴ 鿡Դ ڻ Ǿǰ ؿܽ Ǿǰ ִٴ ũ ȯް ִ.
cGMPؿ ´ ּ õ ڵž ʴ ̴. ̵ 翡Դ 2010 cGMP ߶ ִ κ̴.
ڵ cGMP ʴ´١ ؿ ϰ 鿡Դ cGMP ߶ μ ο ִ١ ߴ.
3 ڱ ֱ 濡 cGMP ִ ڴ ӻ 㰡 ȭǸ cGMP ؿ յ ʾ ƿ 㰡 ִ١ ľû ϶ϱ ¿ ϴ ũ١ .
簡 cGMPؿ ص ؿܿ ϴ ͺ . ؿ õ 忡 cGMPؿ ٰ ˾Ƽ Ǵ ƴϱ ̴.
ڴ ѹ FTA ȴٰ ġ ̱ cGMP ̳ ƿ ִ١ 翡Դ ȸ ڱ Ϻ 翡Դ ִ ١ ߴ.
(kwakdo97@mdtoday.co.kr)
<ǰ ̴ ѹα ǥ Ƿ, ǰ Ź , >
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