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cGMP 1, ¥ ñ
, 2010 ''...߼ 'ο '
Ϻ Ʈ Ȯ Է : 2008-07-18 07:58:51
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)


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