ʲôGMP
GMPӢGood Manufacturing Practice Ŀsĵ˼ǡI(y)Ҏ(gu)ǡ(yu)˜ʡһNeעa(chn)^Ќʩa(chn)Ʒ|(zh)cl(wi)ȫԹƶһmˎʳƷИI(y)ďԘ˜ҪI(y)ԭˆTO(sh)ʩO(sh)a(chn)^̡b\ݔ|(zh)Ƶȷ水P(gun)Ҏ(gu)_l(wi)|(zh)ҪγһɲI(y)Ҏ(gu)I(y)I(y)l(wi)h(hun)rl(f)F(xin)a(chn)^дڵĆ}ԸҪfGMPҪʳƷa(chn)I(y)(yng)߂õa(chn)O(sh)a(chn)^̣Ƶ|(zh)͇ęzyϵy(tng)_Ka(chn)Ʒ|(zh)ʳƷȫl(wi)ϷҎ(gu)Ҫ
GMPҎ(gu)ă(ni)ʳƷӹI(y)_ėl
ʳƷGMPx
ʳƷa(chn)ṩһױѭĽMϘ˜ʡ
l(wi)TʳƷl(wi)O(jin)TṩO(jin)z(j)
齨HʳƷ˜ṩA(ch)
ʳƷćHQ(mo)ס
ʹʳƷa(chn)(jng)IˆTJRʳƷa(chn)ṩҪĽ̲ɴˮa(chn)eOĹB(ti)l(f)ʳƷ|(zh)߶ؓ؟ľa(chn)ϵIJT
ʹʳƷa(chn)I(y)ԭoϡbϵҪ
ʳƷa(chn)I(y)¼g(sh)O(sh)ĶCʳƷ|(zh)
ʳƷGMPĻǣ
ʳƷa(chn)^˞e`ֹʳƷa(chn)^ȾƷ|(zh)׃ȫƷ|(zh)Cwϵ
ʳƷGMPҪĿǣ
ʳƷƷ|(zh)cl(wi)ȫ
Mca(chn)ߵę(qun)
ʳƷa(chn)ߵw
MʳƷI(y)Ľȫl(f)չ
ʳƷGMPĻԭtǣ
һʳƷGMP֮УJCƶɘI(y)Ը
ʳƷGMP֮ӆͨtctɷNͨtmʳƷStea(chn)Ʒ|(zh)ͬHҪӆ
ʳƷGMPa(chn)Ʒ֮ӆЇҘ˜ߑ(yng)Ҏ(gu)δӆߵÅzλ?q)Wg(sh)оC(gu)J֮ͬ
GMPʳƷȫć(ni)⑪(yng)r:
GMPԭ^(yng)ˎI(y)F(xin)SҌʳƷI(y)ƶ(yng)GMPҎ(gu)猢GMPڹI(y)a(chn)1969FDAl(f)ʳƷӹbͱa(chn)Ҏ(gu)QGMPFGMPm(x)l(f)ʳƷGMPĿǰƌʩʳƷGMPGMPʮԁȫ(ni)IJٰl(f)_ҺͰl(f)չ҇ҵõJɲɼ{1969l(wi)Mȫ]GMP1972Wͬw14ɆTGMPtձӢ¼ºͺܶI(y)MMʳƷGMPձʡ1975_ʼƶʳƷl(wi)Ҏ(gu) ҇CˎƷa(chn)GMP˜I(y)GMPJCʹˎƷa(chn)ˮƽ^̶ȵ҇ʳƷI(y)|(zh)Ҏ(gu)ƶ_ʼڰʮ1988_ʼ҇ȺC17ʳƷI(y)l(wi)Ҏ(gu)cSO(sh)O(sh)ʩI(y)l(wi)ȷl(wi)ҪԴM҇ʳƷl(wi)rĸA(y)ͿƸNк،ʳƷȾ
1998l(wi)CˡʳƷa(chn)Ҏ(gu)GB17405-1998͡ʳƷa(chn)Ҏ(gu)GB17404-1998@҇CʳƷGMPԘ˜ʡͬ"l(wi)Ҏ(gu)"ͻcƷ|(zh)ă(ni)I(y)ˆT|(zh)YҲ˾wҪSӲa(chn)^̹l(wi)ҪӾwȫڣl(wi)߀MƶƷƷTʳƷI(y)GMPMm(x)l(f)ʩ҇_^(q)Ҳ1988ȫ揊ƌʩˎƷGMP1989ʳƷa(chn)Ҏ(gu)
ʳƷGMPJC־̖f:
־
OKքݣġ
MߌJCa(chn)Ʒİȫl(wi)ஔġ
ЦM⡹
MߌJCa(chn)ƷƷ|(zh)ஔM⡹
ʳƷGMPJCľ̖9(sh)Mɣ̖ǰaJCa(chn)ƷĮa(chn)Ʒ e3~5aQ鹤S̖JCa(chn)Ʒ칤Sȡԓa(chn)ƷeȺ̖6~9aQa(chn)Ʒ̖JCa(chn)Ʒ̖
ʳƷGMPJC̖a(chn)JCîa(chn)ƷJCÿһJCa(chn)ƷٵʳƷGMPJC̖
λaε 1 2 3 4 5 6 7 8 9
x JCa(chn)ƷĮa(chn)Ʒe S̖ a(chn)Ʒ̖
ʳƷGMPJCA(ch)Ҫ
GMPGood Manufacture PracticeһNЌI(y)ԵƷ|(zh)CwϵǞ鱣ʳƷȫ|(zh)ƶ؞ʳƷa(chn)ȫ^̵һϵдʩͼg(sh)ҪһNeעa(chn)^Юa(chn)ƷƷ|(zh)cl(wi)ȫԹƶһNwĮa(chn)Ʒ|(zh)CwϵҪS졢bA\a(chn)Ʒ^̵P(gun)ˆTԼO(sh)ʩO(sh)ȵO(sh)ül(wi)^̡a(chn)Ʒ|(zh)ȹܷa(chn)Ҏ(gu)ֹa(chn)Ʒڲl(wi)lȾƷ|(zh)׃ĵĭh(hun)a(chn)pa(chn)¹ʵİl(f)_a(chn)Ʒȫl(wi)Ʒ|(zh)(wn)_Ʒ|(zh)Ϙ˜
GMPҪa(chn)I(y)(yng)õa(chn)O(sh)䣬a(chn)^Ƶ|(zh)͇ęzyϵy(tng)Ҫ(ni)ݰ
1țQlmļӹh(hun)S ·гرˮϵy(tng)U̎ȣ
2O(sh)ʩgAؿgؿggĹoLˮˮO(sh)ʩmˆTMɵ
3ӹ|(zh)ُIAأCCϡbӄӹoƷʹüƷ^b˺ͳƷƷ}졢\ݔͷƷټӹƷՈzԇõČҲ
4l(wi)ʳƷȫzyăؗl̎ÓˮWϴӋϴˮxl(wi)Ͳٙzy鲣zyԼW|(zh)zy
5؟ṩYԴͱO(jin)|(zh)Cͼg(sh)ˆTˆTӖṩl(wi)O(jin)M̶a(chn)Ʒ
w(ni)݅醱վʳƷSGMPͨtP(gun)tҪ
I(y)ʂGMPJCij
Ԕ(ni)݅醱վ: ʳƷGMPJCwϵR
GMPGood Manufacture PracticeһNЌI(y)ԵƷ|(zh)CwϵǞ鱣ʳƷȫ|(zh)ƶ؞ʳƷa(chn)ȫ^̵һϵдʩͼg(sh)ҪһNeעa(chn)^Юa(chn)ƷƷ|(zh)cl(wi)ȫԹƶһNwĮa(chn)Ʒ|(zh)CwϵҪSbA\a(chn)Ʒ^̵P(gun)ˆTԼO(sh)ʩO(sh)ȵO(sh)ül(wi)^a(chn)Ʒ|(zh)ȹܷa(chn)Ҏ(gu)ֹa(chn)Ʒڲl(wi)lȾƷ|(zh)׃ĵĭh(hun)a(chn)pa(chn)¹ʵİl(f)_a(chn)Ʒȫl(wi)Ʒ|(zh)(wn)_Ʒ|(zh)Ϙ˜ʡ
GMPҪa(chn)I(y)(yng)õa(chn)O(sh)a(chn)^Ƶ|(zh)͇ęzyϵy(tng)Ҫ(ni)ݰ
1țQlmļӹh(hun)S ·гرˮϵy(tng)U̎
2O(sh)ʩgAؿgؿggĹoLˮˮO(sh)ʩmˆTMɵ
3ӹ|(zh)ُIAأCCϡbϡӄӹoƷʹüƷ^b˺ͳƷƷ}\ݔͷƷټӹƷՈzԇõČҲȣ
4l(wi)ʳƷȫzyăؗl̎ÓˮWϴӋϴˮxl(wi)Ͳٙzy鲣zyԼW|(zh)zy
5؟ṩYԴͱO(jin)|(zh)Cͼg(sh)ˆTˆTӖṩl(wi)O(jin)M̶a(chn)Ʒ
w(ni)݅醱վʳƷSGMPͨtP(gun)tҪ
I(y)ʂGMPJCij
Ԕ(ni)݅醱վ: ʳƷGMPJCwϵR |