ʲôGMP
GMPӢGood Manufacturing Practice Ŀsĵ˼ǡI(y)Ҏ(gu)ǡ(yu)˜ʡһNeעa^ЌʩaƷ|cl(wi)ȫԹƶȡһmˎʳƷИI(y)ďԘ˜ҪI(y)ԭˆTOʩOa^b\ݔ|Ƶȷ水PҎ(gu)_l(wi)|ҪγһɲI(y)Ҏ(gu)I(y)I(y)l(wi)h(hun)rl(f)F(xin)a^дڵĆ}ԸҪfGMPҪʳƷaI(y)߂õaOa^Ƶ|͇ęzyϵy(tng)_KaƷ|ʳƷȫl(wi)ϷҎ(gu)Ҫ
GMPҎ(gu)ăݣʳƷӹI(y)_ėl
ʳƷGMPx
ʳƷaṩһױѭĽMϘ˜
l(wi)TʳƷl(wi)O(jin)TṩO(jin)z(j)
齨HʳƷ˜ṩA
ʳƷćHQס
ʹʳƷa(jng)IˆTJRʳƷaṩҪĽ̲ɴˮaeOĹB(ti)l(f)ʳƷ|߶ؓ؟ľaϵIJT
ʹʳƷaI(y)ԭobϵҪ
ʳƷaI(y)¼gOĶCʳƷ|
ʳƷGMPĻǣ
ʳƷa^˞e`ֹʳƷa^ȾƷ|׃ȫƷ|Cwϵ
ʳƷGMPҪĿǣ
ʳƷƷ|cl(wi)ȫ
Mcaߵę
ʳƷaߵwơ
MʳƷI(y)Ľȫl(f)չ
ʳƷGMPĻԭtǣ
һʳƷGMP֮JCƶɘI(y)Ը
ʳƷGMP֮ӆͨtctɷNͨtmʳƷSteaƷ|ͬHҪӆ
ʳƷGMPaƷ֮ӆЇҘ˜ߑҎ(gu)δӆߵÅzλWgоCJ֮ͬ
GMPʳƷȫć⑪r:
GMPԭ^ˎI(y)F(xin)SҌʳƷI(y)ƶGMPҎ(gu)猢GMPڹI(y)a1969FDAl(f)ʳƷ졢ӹbͱaҎ(gu)QGMPFGMPm(x)l(f)ʳƷGMPĿǰƌʩʳƷGMPGMPʮԁȫȵIJٰl(f)_ҺͰl(f)չ҇ҵõJɲɼ{1969꣬l(wi)Mȫ]GMP1972Wͬw14ɆTGMPtձӢ¼ºͺܶI(y)MMʳƷGMPձʡ1975_ʼƶʳƷl(wi)Ҏ(gu) ҇CˎƷaGMP˜I(y)GMPJCʹˎƷaˮƽ^̶ȵߡ҇ʳƷI(y)|Ҏ(gu)ƶ_ʼڰʮ1988_ʼ҇ȺC17ʳƷI(y)l(wi)Ҏ(gu)cSOOʩI(y)l(wi)ȷl(wi)ҪԴM҇ʳƷl(wi)rĸAͿƸNк،ʳƷȾ
1998l(wi)CˡʳƷaҎ(gu)GB17405-1998͡ʳƷaҎ(gu)GB17404-1998@҇CʳƷGMPԘ˜ʡͬ"l(wi)Ҏ(gu)"ͻcƷ|ăI(y)ˆT|YҲ˾wҪSӲa^̹l(wi)ҪӾwȫڣl(wi)߀MƶƷƷϡTʳƷI(y)GMPMm(x)l(f)ʩ҇_^(q)Ҳ1988ȫ揊ƌʩˎƷGMP1989ʳƷaҎ(gu)
ʳƷGMPJC־̖f:
־
OKքݣġ
MߌJCaƷİȫl(wi)ஔġ
ЦM⡹
MߌJCaƷƷ|ஔM⡹
ʳƷGMPJCľ̖9(sh)M̖ǰaJCaƷĮaƷ e3~5aQ鹤S̖JCaƷ칤SȡԓaƷeȺ̖6~9aQaƷ̖JCaƷ̖
ʳƷGMPJC̖aJCîaƷJCÿһJCaƷٵʳƷGMPJC̖
λaε 1 2 3 4 5 6 7 8 9
x JCaƷĮaƷe S̖ aƷ̖
ʳƷGMPJCAҪ
GMPGood Manufacture PracticeһNЌI(y)ԵƷ|CwϵǞ鱣ʳƷȫ|ƶ؞ʳƷaȫ^̵һϵдʩͼgҪһNeעa^ЮaƷƷ|cl(wi)ȫԹƶȣһNwĮaƷ|CwϵҪSbA\aƷ^̵PˆTԼOʩOȵOül(wi)^aƷ|ȹܷaҎ(gu)ֹaƷڲl(wi)lȾƷ|׃ĵĭh(hun)apa¹ʵİl(f)_aƷȫl(wi)Ʒ|(wn)_Ʒ|Ϙ˜ʡ
GMPҪaI(y)õaOa^̣Ƶ|͇ęzyϵy(tng)Ҫݰ
1țQlmļӹh(hun)S ·гرˮϵy(tng)U̎ȣ
2OʩgAؿgؿggĹoLˮˮۡOʩmˆTMɵȣ
3ӹء|ُIACCbӄӹoƷʹüԣƷ^b˺ͳƷƷ}졢\ݔͷ䣻ƷټӹƷՈzԇõČҲ
4l(wi)ʳƷȫzyăؗl̎ءÓˮWϴӋϴˮxl(wi)Ͳٙzy鲣zyԼW|zy
5؟ṩYԴͱO(jin)|CͼgˆTˆTӖṩl(wi)O(jin)M̶aƷ
w݅醱վʳƷSGMPͨtPtҪ
I(y)ʂGMPJCij
Ԕ݅醱վ: ʳƷGMPJCwϵR
GMPGood Manufacture PracticeһNЌI(y)ԵƷ|CwϵǞ鱣ʳƷȫ|ƶ؞ʳƷaȫ^̵һϵдʩͼgҪһNeעa^ЮaƷƷ|cl(wi)ȫԹƶһNwĮaƷ|CwϵҪSbA\aƷ^̵PˆTԼOʩOȵOül(wi)^̡aƷ|ȹܷaҎ(gu)ֹaƷڲl(wi)lȾƷ|׃ĵĭh(hun)apa¹ʵİl(f)_aƷȫl(wi)Ʒ|(wn)_Ʒ|Ϙ˜
GMPҪaI(y)õaO䣬a^Ƶ|͇ęzyϵy(tng)Ҫݰ
1țQlmļӹh(hun)S ·гرˮϵy(tng)U̎
2OʩgAؿgؿggĹoLˮˮOʩmˆTMɵ
3ӹء|ُIAأCCϡbӄӹoƷʹüԣƷ^b˺ͳƷƷ}\ݔͷƷټӹƷՈzԇõČҲ
4l(wi)ʳƷȫzyăؗl̎ÓˮWأϴӋϴˮxl(wi)Ͳٙzy鲣zyԼW|zy
5؟ṩYԴͱO(jin)|CͼgˆTˆTӖṩl(wi)O(jin)M̶aƷ
w݅醱վʳƷSGMPͨtPtҪ
I(y)ʂGMPJCij
Ԕ݅醱վ: ʳƷGMPJCwϵR |