Qhov sib txawv ntawm ISO thiab GMP cov qauv huv GMP
1. Cov tau thiab daim ntawv thov
Iso 14644-1:
Tau luag: Iso {{14644-1 yog muaj kev sib txuam nrog kev lag luam hauv ntiaj teb, suav nrog cov pa hluav taws xob, suav nrog ntau cov pa hluav taws xob ua ke ntawm cov pa hluav taws xob raws li cov pa hluav taws xob, thiab cov khoom siv biotechnology, thiab tshuaj biotechnology, thiab kws tshuaj .
Daim ntawv thov: Nws muab txoj kev ua qauv rau kev tsim qauv, kev ua haujlwm, thiab cov kev ua haujlwm ua haujlwm kom ntseeg tau tias huv si cov qib .
GMP (Kev Tsim Kev Raug Zoo):
Tau luag: GMP yog txheej txheej txheem qhia tshwj xeeb tsim rau cov khoom lag luam thiab kev nyab xeeb ntawm cov tshuaj lom neeg .
Daim ntawv thov: GMP tsom rau tag nrho cov txheej txheem tsim khoom, suav nrog kev tswj hwm zoo, cov neeg ua haujlwm ntawm kev saib xyuas .
2. Kev cai vs .}}} |
Iso 14644-1:
Kev cai tswj hwm: ISO cov qauv yog feem ntau lees txais raws li kev coj ua zoo tshaj plaws thiab muaj peev xwm saws los ntawm cov koom haum kom ntseeg tau cov kev ua dej huv zoo {}}
GMP:
Kev cai tswj hwm: GMP yog txoj cai tswj hwm tau siv los ntawm cov tub ceev xwm xws li kev ua haujlwm hauv GMP (FDA) thiab siv tshuaj rau cov tuam txhab ua lag luam (FDA)
3. Tsom cov chaw
Iso 14644-1:
Tsom: Hais txog kev faib tawm thiab kev tswj hwm ntawm cov khoom huv, suav nrog kev soj ntsuam thiab huab cua kom ntau ntawm cov sib txawv ntawm cov sib txawv.
GMP:
Tsom: Muab lub ntsiab lus muaj zog ntawm kev tswj hwm tag nrho, uas suav nrog kev siv tau thiab kev saib xyuas ua haujlwm ntxiv rau hauv kev suav nrog kev suav nrog.
4. Particle tswj thiab ntsuas
Iso 14644-1:
Qho ntsuas: ISO cov qauv ntsuas cov khoom siv hauv cubic me me ntawm ISO chav kawm 1 (qhov tsawg dua huv).
Qhov ntau thiab tsawg: ISO cov qauv ntsuas ntsuas cov lus ntawm ntau qhov ntau thiab tsawg, suav nrog 0 {}} 1 μm, 0.3 μm, thiab 0.5 μm.
GMP:
Qho ntsuas: GMP Cov Qauv Ntsuas Ntsuas ob qho tib si "ntawm so" thiab "hauv kev ua haujlwm yog qhov tseem ceeb ntawm cov tshuaj lag luam {}}
Qhov ntau thiab tsawg: GMP cov qauv tsom xam rau cov ntsiab ntau dua lossis sib npaug 0 .}}}} μm, thiab kuj suav nrog kev txwv microciological.
5. Kev ua kom huv huv
Iso 14644-1:
Kev sib faib: ISO chav kawm 1 yog qhov huv tshaj plaws, nrog qhov qis qis particle concentration, thaum ay chav 9 yog tsawg kawg ntxuav.
GMP:
Kev sib faib: GMP classifies huv thaj chaw rau qib d .} {1} {1} {.
6. Kev sib sau ntawm ISO thiab GMP
ISO thiab GMP Kev Sib Tham:
Qib A: Sib haum rau ISO chav kawm 5 (thaum so thiab hauv kev ua haujlwm) .
Qib B: Sib haum rau ISO chav kawm 5 (thaum so) thiab ISO chav kawm 7 (hauv kev ua haujlwm).
Qib C: Sib haum rau ISO chav kawm 7 (thaum so) thiab ISO chav kawm 8 (hauv kev ua haujlwm).
Qeb D: Sib haum rau ISO chav kawm 8 (ntawm so) thiab tsis tau muaj kev txwv tsis pub dhau .