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òҎ(gu)GMPԵʳƷa(chn)Al(wi)Ҏ(gu)70ڣFDA˼ӏƌʳƷıO(jin)(j)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 mڋ냺ʳƷĠIB(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)ʩҎ(gu)
W˵ʳƷl(wi)Ҏ(gu)Ҫ
ʩƵҎ(gu)
r(nng)FʩƵҎ(gu)
ʳƷa(chn)ͶЈl(wi)Ҏ(gu)
zʩƵҎ(gu)
ʳƷ(zhn)ĿҎ(gu)
ڇ(dng)l(wi)CҎ(gu)
҇(j)HʳƷQ(mo)Ҫ1984ԭ̙zƶGMPl(wi)Ҏ(gu)ʳƷSl(wi)ҪʳƷa(chn)I(y)ˏԵl(wi)Ҏ(gu)ʮڡȫʳƷоУ˷NʳƷӆGMP
(j)ʳƷQ(mo)ȫİl(f)չԼʳƷȫl(wi)ҪʳƷSl(wi)Ҫѽ(jng)m(yng)΄ݵҪ(jng)^199411°l(f)ˡʳƷSl(wi)Ҫڴ˻A(ch)ϣm(x)l(f)9I(y)l(wi)Ҏ(gu)
⼰ƷӹI(y)עl(wi)Ҏ(gu)
ڹ^ӹI(y)עl(wi)Ҏ(gu)
ˮa(chn)ƷӹI(y)עl(wi)Ҏ(gu)
ϼӹI(y)עl(wi)Ҏ(gu)
ڲ~ӹI(y)עl(wi)Ҏ(gu)
ӹI(y)עl(wi)Ҏ(gu)
ƷӹI(y)עl(wi)Ҏ(gu)
كʳƷӹI(y)עl(wi)Ҏ(gu)
c¼ӹI(y)עl(wi)Ҏ(gu)
19881991҇C15ʳƷӹI(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
cSl(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 |