Dab tsi yog qhov txawv ntawm GMP thiab tsis yog GMP kuaj?
Dab tsi yog qhov txawv ntawm GMP thiab tsis yog GMP kuaj?

Video: Dab tsi yog qhov txawv ntawm GMP thiab tsis yog GMP kuaj?

Video: Dab tsi yog qhov txawv ntawm GMP thiab tsis yog GMP kuaj?
Video: Yog tsis sib hlub yuav zoo dab tsi? 2024, Hlis ntuj nqeg
Anonim

GMP (FDA tswj) vs. tsis - GMP ( tsis -regulated) cov khoom raw khoom. Peb yuav cov khoom siv tshuaj tib yam rau GMP thiab tsis yog - GMP ntau lawm. GMP tau txais cov khoom yuav tsum tau a txawv workflow tshaj tsis - GMP tau txais cov khoom (tsuas yog GMP yuav tsum tau kuaj kev lees paub sab hauv, tsis - GMP tsis yog).

Ib yam li ntawd, koj tuaj yeem nug, GMP lub chaw kuaj mob yog dab tsi?

Kev Ua Haujlwm Zoo ( GMP ) yog ib txoj hauv kev los xyuas kom meej tias cov khoom siv tshuaj tau tsim thiab tswj tau raws li cov qauv zoo. GMP lab yog siv rau ntau lub hom phiaj- txhawb kev tshawb fawb txog kev txhais lus, koom nrog hauv kev sim tshuaj, kev txhim kho kev lag luam, thiab lwm yam.

Tsis tas li, GMP cov cai yog dab tsi? Kev coj ua zoo ( GMP ) yog cov kev coj ua uas yuav tsum tau ua kom ua raws li cov lus pom zoo los ntawm cov koom haum uas tswj kev tso cai thiab kev tso cai ntawm kev tsim thiab muag khoom noj thiab dej haus, tshuaj pleev ib ce, khoom siv tshuaj, khoom noj khoom haus, thiab khoom siv kho mob.

Ntawm no, qhov txawv ntawm GLP thiab GMP cov cai rau cov chaw kuaj mob yog dab tsi?

Cov GLP cov cai yog npaj los xyuas kom meej qhov zoo thiab kev ncaj ncees ntawm "qhib-kawg" kev tshawb fawb kev tshawb fawb ntawm cov khoom muaj kev ruaj ntseg, thaum lub GMP cov cai yog npaj los xyuas kom meej qhov zoo thiab kev nyab xeeb ntawm ib tug neeg batch ntawm tswj cov khoom kho mob los ntawm kev tsim thiab kev ntsuam xyuas raws li cov txheej txheem ua ntej, Dab tsi yog qhov txawv ntawm GMP thiab cGMP?

Ob leeg cGMP thiab GMP raug muab tso rau hauv qhov chaw los ua pov thawj kev ruaj ntseg ntawm cov khoom. Txawm li cas los xij, muaj me ntsis qhov sib txawv ntawm cGMP thiab GMP . Qhov "c" hauv cGMP yog nyob rau hauv qhov chaw lees paub tias txhua kauj ruam siv los tsim cov khoom no tau ua tiav raws li cov lus qhia ntawm GMP tau hais, tab sis lawv twb tiav lawm hauv a ntau yam tam sim no.

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