òҎ(gu)l(f)չ(jin)
òҎ(gu)GMP(qing)ԵʳƷa(chn)Al(wi)Ҏ(gu)70ڣ(gu)FDA˼ӏ(qing)ƌ(du)ʳƷıO(jin)(j)(gu)ʳƷˎﻯyƷ402aҎ(gu)ڲl(wi)ėla(chn)bAʳƷa(chn)ʳƷla(chn)ʳƷҕ鲻l(wi)ȫƶʳƷa(chn)ĬF(xin)òҎ(gu)21CFR part 110@һҎ(gu)mһʳƷļӹa(chn)AS֮FDA^ƶ˸ʳƷIJҎ(gu)磺
21 CFR part 106 mڋ냺ʳƷĠI(yng)B(yng)Ʒ|(zh)
21 CFR part 113 mڵ^ʳƷӹI(y)
21 CFR part 114 mữʳƷӹI(y)
21 CFR part 129 mƿb
ڼôl(wi)HPBաʳƷˎƶˡʳƷ취Ҏ(gu)GMRF
CACƶˡʳƷl(wi)ͨtCAC/RCP1-1969 Rev.3(1997)һЩʳƷa(chn)l(wi)(sh)ʩҎ(gu)
W˵ʳƷl(wi)Ҏ(gu)Ҫ
(du)(sh)ʩƵҎ(gu)
(du)r(nng)F(sh)ʩƵҎ(gu)
(du)ʳƷa(chn)ͶЈ(chng)l(wi)Ҏ(gu)
(du)z(yn)(sh)ʩƵҎ(gu)
(du)(gu)ʳƷ(zhn)ĿҎ(gu)
(du)ڇ(gu)(dng)l(wi)CҎ(gu)
҇(gu)(j)(gu)HʳƷQ(mo)Ҫ1984ԭ(gu)̙zƶGMPl(wi)Ҏ(gu)ʳƷS(k)l(wi)Ҫ(du)ʳƷa(chn)I(y)ˏ(qing)Եl(wi)Ҏ(gu)ʮڡȫʳƷо(du)˷NʳƷӆGMP
(j)ʳƷQ(mo)ȫİl(f)չԼ(du)ʳƷȫl(wi)ҪʳƷS(k)l(wi)Ҫѽ(jng)m(yng)΄(sh)Ҫ(jng)^(gu)199411°l(f)ˡʳƷS(k)l(wi)Ҫڴ˻A(ch)m(x)l(f)9(g)I(y)l(wi)Ҏ(gu)
⼰ƷӹI(y)ע(c)l(wi)Ҏ(gu)
ڹ^ӹI(y)ע(c)l(wi)Ҏ(gu)
ˮa(chn)ƷӹI(y)ע(c)l(wi)Ҏ(gu)
ϼӹI(y)ע(c)l(wi)Ҏ(gu)
ڲ~ӹI(y)ע(c)l(wi)Ҏ(gu)
ӹI(y)ע(c)l(wi)Ҏ(gu)
ƷӹI(y)ע(c)l(wi)Ҏ(gu)
كʳƷӹI(y)ע(c)l(wi)Ҏ(gu)
c¼ӹI(y)ע(c)l(wi)Ҏ(gu)
19881991꣬҇(gu)C15(g)ʳƷӹI(y)l(wi)Ҏ(gu)
^Sl(wi)Ҏ(gu) GB8950-88
ƏSl(wi)Ҏ(gu) GB8951-88
ơƏSl(wi)Ҏ(gu) GB8952-88
u͏Sl(wi)Ҏ(gu) GB8953-88
ʳSl(wi)Ҏ(gu) GB8954-88
ʳֲ͏Sl(wi)Ҏ(gu) GB8955-88
TSl(wi)Ҏ(gu) GB8956-88
c(din)Sl(wi)Ҏ(gu) GB8957-88
ƷSl(wi)Ҏ(gu) GB12693-90
ӹSl(wi)Ҏ(gu) GB12694-90
ϏSl(wi)Ҏ(gu) GB12695-90
ѾƏSl(wi)Ҏ(gu) GB12696-90
ƏSl(wi)Ҏ(gu) GB12697-90
SƏSl(wi)Ҏ(gu) GB12698-90
ۏSl(wi)Ҏ(gu) GB13122-91
1999Cˡˮa(chn)Ʒӹ|(zh)Ҏ(gu)SC/T3009-1999 |