ʲôGMP
GMPӢGood Manufacturing Practice Ŀsĵ˼ǡI(y)Ҏ(gu)ǡ(yu)(bio)(zhn)һNeעa(chn)^Ќ(sh)ʩ(du)a(chn)Ʒ|(zh)cl(wi)ȫԹƶһmˎʳƷИI(y)ď(qing)Ԙ(bio)(zhn)ҪI(y)ԭˆTO(sh)ʩO(sh)a(chn)^b\(yn)ݔ|(zh)Ƶȷ水P(gun)Ҏ(gu)_(d)l(wi)|(zh)ҪγһɲI(y)Ҏ(gu)I(y)I(y)l(wi)h(hun)r(sh)l(f)F(xin)a(chn)^дڵĆ}ԸҪfGMPҪʳƷa(chn)I(y)(yng)߂õa(chn)O(sh)䣬a(chn)^Ƶ|(zh)͇(yn)ęzyϵy(tng)_Ka(chn)Ʒ|(zh)ʳƷȫl(wi)ϷҎ(gu)Ҫ
GMPҎ(gu)ă(ni)ʳƷӹI(y)_(d)ėl
ʳƷGMPx
ʳƷa(chn)ṩһױѭĽMϘ(bio)(zhn)
l(wi)TʳƷl(wi)O(jin)TṩO(jin)z(j)
齨HʳƷ(bio)(zhn)ṩA(ch)
ʳƷćHQ(mo)
ʹʳƷa(chn)(jng)IˆTJ(rn)R(sh)ʳƷa(chn)ṩҪĽ̲ɴˮa(chn)eOĹB(ti)l(f)(du)ʳƷ|(zh)߶ؓ(f)؟(z)ľa(chn)ϵIJ(x)T
ʹʳƷa(chn)I(y)(du)ԭϡobϵҪ(yn)
ʳƷa(chn)I(y)¼g(sh)O(sh)䣬ĶCʳƷ|(zh)
ʳƷGMPĻǣ
ʳƷa(chn)^˞e(cu)`ֹʳƷa(chn)^ȾƷ|(zh)׃ȫƷ|(zh)Cwϵ
ʳƷGMPҪĿǣ
ʳƷƷ|(zh)cl(wi)ȫ
M(fi)ca(chn)ߵę(qun)
(qing)ʳƷa(chn)ߵw
M(jn)ʳƷI(y)Ľȫl(f)չ
ʳƷGMPĻԭtǣ
һʳƷGMP֮J(rn)CƶɘI(y)Ըӡ
ʳƷGMP֮ӆͨtctɷNͨtmʳƷSt(g)ea(chn)Ʒ|(zh)ͬ(sh)HҪӆ
ʳƷGMPa(chn)Ʒ֮(yn)ӆЇҘ(bio)(zhn)ߑ(yng)Ҏ(gu)δӆߵÅz(yn)λ?q)Wg(sh)оC(j)(gu)J(rn)֮ͬ
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)ʳƷGMPĿǰ(qing)ƌ(sh)ʩʳƷGMPGMPʮԁȫ(ni)IJٰl(f)_(d)ҺͰl(f)չ҇ҵõJ(rn)ɲɼ{1969꣬l(wi)Mȫ]GMP1972Wͬw14(g)ɆTGMPtձӢ¼ºͺܶI(y)M(jn)M(jn)ʳƷGMPձʡ1975_ʼƶʳƷl(wi)Ҏ(gu) ҇CˎƷa(chn)GMP(bio)(zhn)(sh)I(y)GMPJ(rn)CʹˎƷa(chn)ˮƽ^̶ȵ҇ʳƷI(y)|(zh)Ҏ(gu)ƶ_ʼڰʮ1988_ʼ҇ȺC17(g)ʳƷI(y)l(wi)Ҏ(gu)c(din)(du)SO(sh)O(sh)ʩI(y)l(wi)ȷl(wi)ҪԴM(jn)҇ʳƷl(wi)rĸA(y)ͿƸNк،(du)ʳƷȾ
1998l(wi)CˡʳƷa(chn)Ҏ(gu)GB17405-1998͡ʳƷa(chn)Ҏ(gu)GB17404-1998@҇CʳƷGMP(qing)Ԙ(bio)(zhn)ͬ"l(wi)Ҏ(gu)"ͻc(din)Ʒ|(zh)ă(ni)ݣ(du)I(y)ˆT|(zh)YҲ˾wҪ(du)SӲa(chn)^̹l(wi)ҪӾwȫ(yn)l(wi)߀MƶƷƷTʳƷI(y)GMPMm(x)l(f)(sh)ʩ҇_(ti)^(q)Ҳ1988ȫ揊(qing)ƌ(sh)ʩˎƷGMP1989ʳƷa(chn)Ҏ(gu)
ʳƷGMPJ(rn)C(bio)־̖(ho)f:
(bio)־
OKքݣġ
M(fi)ߌ(du)J(rn)Ca(chn)Ʒİȫl(wi)ஔ(dng)ġ
ЦM⡹
M(fi)ߌ(du)J(rn)Ca(chn)ƷƷ|(zh)ஔ(dng)M⡹
ʳƷGMPJ(rn)Cľ̖(ho)9(g)(sh)M̖(ho)ǰaJ(rn)Ca(chn)ƷĮa(chn)Ʒ e3~5aQ鹤S̖(ho)J(rn)Ca(chn)Ʒ칤Sȡԓa(chn)ƷeȺ̖(ho)6~9aQa(chn)Ʒ̖(ho)J(rn)Ca(chn)Ʒ̖(ho)
ʳƷGMPJ(rn)C̖(ho)a(chn)J(rn)Cîa(chn)ƷJ(rn)Cÿһ(xing)J(rn)Ca(chn)ƷٵʳƷGMPJ(rn)C̖(ho)
λaε 1 2 3 4 5 6 7 8 9
x J(rn)Ca(chn)ƷĮa(chn)Ʒe S̖(ho) a(chn)Ʒ̖(ho)
ʳƷGMPJ(rn)CA(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)CwϵҪSbA\(yn)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(bio)(zhn)
GMPҪa(chn)I(y)(yng)õa(chn)O(sh)a(chn)^Ƶ|(zh)͇(yn)ęzyϵy(tng)Ҫ(ni)ݰ
1țQlmļӹh(hun)S ·гرˮϵy(tng)U̎ȣ
2O(sh)ʩgAؿgؿggĹoL(fng)ˮˮO(sh)ʩmˆTMɵ
3ӹ(ch)|(zh)ُIAC(j)C(j)bϡӄӹoƷʹüԣƷ^b(bio)ͳƷƷ}\(yn)ݔͷ䣻ƷټӹƷՈzԇ(yn)õČ(sh)(yn)Ҳ
4l(wi)ʳƷȫzyă(ch)ؗl̎ÓˮW(xu)أϴӋ(j)ϴˮx(g)l(wi)Ͳٙzy鲣zyԼW(xu)|(zh)zy
5؟(z)ṩYԴͱO(jin)|(zh)Cͼg(sh)ˆTˆTӖ(xn)ṩl(wi)O(jin)M̶a(chn)Ʒȡ
w(ni)݅醱վʳƷSGMPͨtP(gun)tҪ
I(y)(zhn)GMPJ(rn)Cij
Ԕ(x)(ni)݅醱վ: ʳƷGMPJ(rn)CwϵR
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\(yn)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(bio)(zhn)
GMPҪa(chn)I(y)(yng)õa(chn)O(sh)a(chn)^Ƶ|(zh)͇(yn)ęzyϵy(tng)Ҫ(ni)ݰ
1țQlmļӹh(hun)S ·гرˮϵy(tng)U̎
2O(sh)ʩgAؿgؿggĹoL(fng)ˮˮۡO(sh)ʩmˆTMɵȣ
3ӹ(ch)ء|(zh)ُIAC(j)C(j)bӄӹoƷʹüԣƷ^b(bio)ͳƷ棻Ʒ}\(yn)ݔͷƷټӹƷՈzԇ(yn)õČ(sh)(yn)Ҳȣ
4l(wi)ʳƷȫzyă(ch)ؗl̎ÓˮW(xu)ϴӋ(j)ϴˮx(g)l(wi)Ͳơٙzy鲣zyԼW(xu)|(zh)zy
5؟(z)ṩYԴͱO(jin)|(zh)Cͼg(sh)ˆTˆTӖ(xn)ṩl(wi)O(jin)M̶ȣa(chn)Ʒ
w(ni)݅醱վʳƷSGMPͨtP(gun)tҪ
I(y)(zhn)GMPJ(rn)Cij
Ԕ(x)(ni)݅醱վ: ʳƷGMPJ(rn)CwϵR |