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╖ЙбЙ A╣2003-43б╤ 4Б╖в┤С╬A╣б╣бпщмБ╖впС╬A╣б╣4aИ╖Йбпщмб╖w╢бЛЕ║4i╖ A╣ў╕q╨A╡ ╢╖с┤ ВКегA╡AЙ бгбЯ i┤aЭ Б╖eЙi╖ hЧбЙa╕ A╣ў╕с┬б╗┴╡ Б║a╢БРw╢i╖ Ч╨ў╕щ╕a└єд A╣41б╣Б╖ AЛў╕A╡ Б╖a╨a╡ aФq╖┴Й {Иб╖ ╖ЙбЙs╨бУaФ. 2003eС 05й╢ 16й╖ впС╬Б╖в┤С╬e┤х╕ў└w╕ Б╖в┤С╬A╣б╣бпщмБ╖впС╬A╣б╣4aИ╖Йбпщмб╖w╢бЛЕ║ A╣ў╕(e┤) 1. A╣ў╕aмA╖ впС╬с╢Чмєд A╣21б╣ ╣г ╖Хєд бпЧ╨AЛв├ A╣20б╣ ┼ЙeЭ iеa╬9A╣1б╤a╕вб(5)Б╖ AЛў╕A╡ Б╖сИ Б╖в┤С╬A╣б╣бпщмi╖ впС╬A╣б╣4aИ╖ЙбпщмбЭ б╖w╢i╨ Бо ╢╖бХвЭ й╧a╢e╨ aмw╨i╖ AнБжт╕a╖бЭ aаeЭa╨a╡ 4Б╖в┤С╬A╣б╣бпщмБ╖впС╬A╣б╣4aИ╖Йбпщмб╖w╢бЛЕ║4i╖ бЙбпa╨бЙa╕ q╨ 2. Б║a╢йЙa╕ ;4 Б╖в┤С╬A╣б╣бпщмi╖ впС╬A╣б╣4aИ╖ЙбпщмбЭ б╖w╢i╨ Бо ╢╖eУ б╗ў╕бЛЕ║ aаeЭ ;4 впС╬┴Й Б╖в┤С╬Б╖ wмб╤х╕б╖wдб╗iЯ с╢e╨ ┼ЙбЯбЛЕ║см wЧ б╗ў╕епў└ БКбзсмAЯiЯ ў╕q╨ ;4 б╗ў╕епў└ смAЯБ╖ т╕ў╕ўм ╣г бпщмБ╖ т╕s╨a╡БжiЯ e╠eФa╨бЛ с╢a╨a╡ Бe┤х╕ўм ёИб╔с╢е╢A╥ВiЯ щмб├4Е╢w╡q╨ ;4 б╗ў╕hдe╖ w╡є┤a╕aИ б╗a┼б┤ i╨ Е║Боaмw╨i╖ AЛў╕q╨ ;4 б╗ў╕w╡є┤a╕A╡ БФe╨ e╡ 1A╥ б╖wмБ╖ aмБ╥┼ЙбЯiЯ йпбпб╔вЭ AЛў╕ 3. A╣ў╕(e┤)A╡ БФe╨ Б╖eЙA╣Й┬ б╖ A╣ў╕e┤A╡ БФa╨a╡ Б╖eЙб╖ ╢╖eУ eФA┴ бЩeУ БИе╖e╖ 2003.06.04.aМб╗ aФq╖ aмw╨i╖ бЛБ╕e╨ Б╖eЙсмiЯ впС╬Б╖в┤С╬e┤х╕ў└w╕(q└б╣ : впС╬e┤х╕┴Йw╕, Б║бн : смЙ╢ e╖w═БК вСхд╖Х 5, х╕┴╤ : 02-380-1726 47, В╠aп : 02-388-6396)A╡AЙ A╣Й┬a╨a╡ Б║бпбЛ aдaЬaб, бЛa╚ a╕Aнe╨ aмw╨e╖ впС╬Б╖в┤С╬e┤х╕ў└ ▒╤A═б╖б╗(http://www.kfda.go.kr)iЯ q└бЙa╨сИaР впС╬e┤х╕┴Й(х╕┴╤хдб╤ : 380-1726, FAX : 388-6396)бЭ ЕвБ╖a╨бпбЛ aдsЬбУaФ. aИ. Б╡бЙaмw╨A╡ БФe╨ w╨вбiе Б╖eЙ(e└4eд a╡Бж┴╡ aЛ б╖A╖) aР. ўмwб(eФA┴Б╖ wЙБ╢ eФA┴wб┴Й БФa╬a╕ ўмwб), Б║бн, х╕┴╤хдб╤ aФ. бЛa╚ й╧a╢e╨ aмw╨ впС╬Б╖в┤С╬e┤х╕ў└ бЙбп A╣2003- 43б╤ впС╬с╢Чмєд A╣21б╣ ╣г ╖Хєд бпЧ╨AЛв├ A╣20б╣ ┼ЙeЭ iеa╬9A╣1б╤a╕вб(5)Б╖ AЛў╕A╡ Б╖сИ 4Б╖в┤С╬A╣б╣бпщмБ╖впС╬A╣б╣4aИ╖Йбпщмб╖w╢бЛЕ║4i╖ aФq╖┴Й {Иб╖ A╣ў╕ бЙбпs╨бУaФ. Б╖в┤С╬A╣б╣бпщмБ╖впС╬A╣б╣4aИ╖Йбпщмб╖w╢бЛЕ║ A╣ў╕(e┤) 2003eС 05й╢ 16й╖ впС╬Б╖в┤С╬e┤х╕ў└w╕ ╬+ A╣1б╣(вбт╕) впС╬с╢Чмєд A╣21б╣ ╣г ╖ХєдбпЧ╨AЛв├ A╣20б╣┼ЙeЭ iеa╬9A╣1б╤a╕вб(5)Б╖ AЛў╕A╡ Б╖e╨ Б╖в┤С╬A╣б╣бпщмi╖ впС╬A╣б╣4aИ╖ЙбпщмбЭ б╖w╢i╨ Бо ╢╖бХвЭ й╧a╢e╨ aмw╨i╖ AЛў╕q╨i╖ вбт╕a╖бЭ e╨aФ. A╣2б╣(б╗ў╕бЛЕ║) Б╖в┤С╬A╣б╣бпщмi╖ впС╬A╣б╣4aИ╖ЙбпщмбЭ б╖w╢i╨ Бо ╢╖eУ б╗ў╕a╢хИe╖ aФq╖Б╖ bИб╤A╡ т╕s╨a╨a╡б┤ e╨aФ. 1. A╣б╣a╨бЙa╕ a╨eУ впС╬┴Й б╖w╢a╨eУ бпщмA╡см ЧмeмAЦeУ Б╖в┤С╬Б╖ ўмЕж ╣г A╣б╣╖Йў╕б╖ A╖aмa╨a╡б┤ e╨aФ. 2. ЧмЙвb╨т╕A╣A╣, A═бУйпеЯA╣A╣, ўмб╤aЯебA╣A╣, aав┤AЯ wЧБ╖ Б╖в┤С╬A╣б╣бпщмe╖ впС╬A╣б╣4aИ╖ЙбпщмбЭ б╖w╢i╨ Бо Ї┤aФ. 3. впС╬┴Й Б╖в┤С╬Б╖ wмб╤х╕б╖iЯ wдб╗a╨бЛ с╢a╨a╡ бЛБЙ4бЛБКAЯ wЧБ╖ Aнт└б╖aР бнвХ wЧA╡ ┼Йe╨ ┼ЙбЯбЛЕ║(Cleaning Validation wдєд б═q╨)i╖ щмў╕a╨a╡б┤ e╨aФ. A╣3б╣(б╗ў╕епў└) Б╖в┤С╬A╣б╣бпщмi╖ впС╬A╣б╣4aИ╖ЙбпщмбЭ б╖w╢a╨бЛ с╢Б╨см б╗ў╕i╖ hдбЙa╕ a╨eУ a╕eУ iеб╗A╣1б╤смвпБ╖ б╗ў╕епў└смA╡ aФq╖ bИб╤Б╖ смAЯiЯ ё└Бжa╨a╡ впС╬Б╖в┤С╬e┤х╕ў└w╕(б╖a╨ Бў└w╕Вб╖aЬ e╨aФ)A╡AЙ A╣Й┬a╨a╡б┤ e╨aФ. 1. Б╖в┤С╬A╣б╣С╬вбс╨aИ бЩeУ епбЙw╗ aмее 2. Чмeмa╨бЙa╕ a╨eУ впС╬Б╖ С╬вбA╣б╣бебЙсм aмее 3. ╖Йw╕бпщмБдб├бХ(б╖w╢a╨бЙa╕ a╨eУ Б╖в┤С╬ б╖w╢бпщм) 4. впС╬┴Й Б╖в┤С╬Б╖ wмб╤х╕б╖wдб╗iЯ с╢e╨ ┼ЙбЯбЛЕ║см A╣4б╣(e┤х╕ўмёИб╔с╢е╢A╥ wЧ) ч6ў└w╕e╖ Б╖в┤С╬ х╕б╖wдб╗iЯ с╢e╨ ┼ЙбЯбЛЕ║Б╖ т╕ў╕ўм ╣г бпщмБ╖ т╕s╨a╡БжiЯ e╠eФa╨бЛ с╢a╨a╡ впС╬Б╖в┤С╬e┤х╕ў└A╡ e┤х╕ўмёИб╔с╢е╢A╥(б╖a╨ "с╢е╢A╥"aЬ e╨aФ)iЯ ЕЦaФ. ш6A╣1w╨Б╖ AЛў╕A╡ Б╖e╨ с╢е╢A╥eУ Б╖в┤С╬х╕ЕвaИ, впС╬х╕ЕвaИ, b╨БЙ wЧ 10wб б╖БРбЭ БКўмe╨aФ. щ6ў└w╕e╖ с╢е╢A╥Б╖ ёИб╔iЙ┴ЙA╡ aШaЬ б╗ў╕епў└смAЯiЯ eдaЭa╨сИaР бе┼╡i╖ a╢БКi╨ Бо ╢╖aФ. A╣5б╣(б╖w╢бпщм б╗ў╕) ч6ў└w╕e╖ A╣3б╣Б╖ AЛў╕A╡ Б╖e╨ б╗ў╕епў└i╖ hдe╖ wЙБ╢A╡eУ A╣2б╣ ╣г A╣4б╣Б╖ ёИб╔iЯ сИa┴ б╗ў╕бЛЕ║A╡ т╕s╨e╨ wЙБ╢A╡ e╨a╨a╡ б╖iЯ б╗ў╕e╨aФ. А└^