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GMPJC630..(2/24)
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(10/29)

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ԃԒ:

020-87270252

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ԃԒ:

020-87270252

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ˮ̎팣ól(f) ⾀UV ڒC ƄӳC ՚C
cҺl(f) ⶾC yнC nҚC C

òҎ(gu)GMPòҎ(gu)

³̎   l(f)rg2005-03-11

    

    һòҎ(gu)

    ьòҎ(gu)GMPʞ鷨Ҏ(gu)̖21 CFR part 110˷Ҏ(gu)mʳƷʳƷa(chn)bAl(wi)Ʒ|(zh)wƵļg(sh)A(ch)зϵď

    21 CFR part 110ƒ(ni)ݣ

    Aֲt

      110.3  x

      110.5  F(xin)еòҎ(gu)

      110.10  ˆT

      110.19  r

    BֲO(sh)ʩ

      110.30  S͈

      110.35  l(wi)

      110.37  l(wi)O(sh)ʩ

    CֲO(sh)

      110.40  O(sh)͹

    Dֲ((ji)A(y)a)

    Eֲa(chn)ͼӹ

      110.80  ӹͿ

      110.93  }cN

    Fֲ((ji)A(y)a)

    GֲȱЄˮƽ

      110.110  ʳƷЌwoȻ򲻿ɱȱ

 

    21 CFR part 110ă(ni)Ҫc£

    110.10  ˆT

    1

    (jng)wzO(jin)ˆT^l(f)F(xin)лܻеKʳƷa(chn)l(wi)ˆTM܇g

    2坍l(wi)

    ӹˆTvl(wi)坍l(wi)Ĺl(f)W(wng)ñӵM܇gŪKҪϴ֡˽Ʒڼӹ^(q)(wn)̵yֹڼӹ^(q)(ni)Ԗ|ϵ

    3ʳƷl(wi)ȫӖ(xn)

 

    110.30  Sc

    1

    ʳƷSܵĈر횱õĠB(ti)ֹʳƷȾߣsx̎ˮͨ

    2SY(ji)(gu)cO(sh)Ӌ

    eca(chn)m(yng)

    ܉ȡm(dng)?sh)A(y)ʩֹȾĝΣ

    ۽Y(ji)(gu)ذ컨坍;Sàr

    ˆTl(wi)^(q)ӹ^(q)ðȫߣ

    ܇gbͨL(fng)O(sh)ֹˮµȾʳƷ

    ޱҪ֮̎O(sh)xֹO(sh)ʩ

 

    110.35  l(wi)

    1һ㱣B(yng)

    S̶büO(sh)ʩl(wi)lMбB(yng)àB(ti)ֹʳƷȾ

    坍xж|(zh)(yng)й(yng)̓(dn)CصطC(gu)ƶP(gun)ʹû@Щa(chn)ƷһP(gun)Ҏ(gu)

    2x

    ʳƷSκ΅^(q)ôκ΄x

    3ʳƷ|l(wi)

    ʳƷ|涼횱Mܽ(jng)M坍ʹЧҰȫ

    (jng)ϴɃĿƄO(sh)估ߴm(dng)?sh)طֹܵȾ?br>
 

    110.37  l(wi)O(sh)ʩ

    1ˮ

    ˮMA(y)ڵI(y)ʹҪˮԴ㣬ˮ|(zh)ȫl(wi)

    2ݔˮO(sh)ʩ

    ݔˮO(sh)ʩijߴO(sh)Ӌbî(dng)So܌ˮ͵ȫSҪˮĵط

    _ŷŏUˮˮ͹ܵϵy(tng)ɽȾSˮUˮŷŕͨ

    3ˮ̎

    ϵy(tng)m(dng)

    4l(wi)gO(sh)ʩ

    Ml(wi)O(sh)ʩO(sh)ԄP(gun)]TT_ʳƷ܇gl(wi)O(sh)ʩ̎àr¡

    5ϴO(sh)ʩ

    ϴO(sh)ʩS(ni)ÿطṩϴֺO(sh)ʩքˮ^ṩm(dng)ضȵˮO(sh)Иʾ

 

    110.40  O(sh)估þ

    SO(sh)þߣO(sh)ӋõIJϺˇ횱ڳֵϴm(dng)?sh)ľSoʹÕrɝȼƬˮȾ

    |ʳƷĽӿpƽSoî(dng)

    ÁAͷʳƷء춼bܜʴ_҃(ni)ضȵĜضӋԄӜybüضԄӛ䛃xԄӈϵy(tng)

    110.80  ӹ

    ʳƷMz顢\ݔxA(y)ӹbAI(y)횇l(wi)ҪM_ʳƷm˂ʳ

    110.93  }cN

    ʳƷƷA桢\ݔֹȾʳƷͰbϲ׃|(zh)

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