Cov Kev Cai Tsim Khoom Zoo lossis GMP yog ib lub kaw lus uas muaj cov txheej txheem, cov txheej txheem thiab cov ntaub ntawv pov thawj uas ua kom cov khoom tsim khoom, xws li zaub mov, tshuaj pleev ib ce, thiab cov khoom siv tshuaj, raug tsim thiab tswj hwm tas li raws li cov qauv zoo uas tau teeb tsa. Kev siv GMP tuaj yeem pab txo qhov kev poob thiab pov tseg, zam kev rov qab hu, kev ntes, kev nplua thiab lub sijhawm raug kaw. Zuag qhia tag nrho, nws tiv thaiv ob lub tuam txhab thiab cov neeg siv khoom los ntawm cov xwm txheej tsis zoo ntawm kev nyab xeeb zaub mov.
Cov kws tshaj lij GMP tshuaj xyuas thiab npog txhua yam ntawm cov txheej txheem tsim khoom kom tiv thaiv txhua yam kev pheej hmoo uas tuaj yeem ua rau cov khoom puas tsuaj loj heev, xws li kev sib kis kab mob, kev sib xyaw ua ke, thiab kev sau ntawv tsis raug. Qee qhov chaw uas tuaj yeem cuam tshuam rau kev nyab xeeb thiab zoo ntawm cov khoom uas GMP cov lus qhia thiab kev cai lij choj hais txog yog cov hauv qab no:
· Kev tswj xyuas zoo
· Kev tu cev thiab kev tu cev
· Lub tsev thiab cov chaw
Cov Khoom Siv
Cov khoom siv raw
Cov Neeg Ua Haujlwm
· Kev lees paub thiab kev tsim nyog
· Cov Lus Tsis Txaus Siab
· Kev sau ntawv thiab kev khaws cov ntaub ntawv
· Kev tshuaj xyuas thiab kev tshuaj xyuas zoo
Qhov txawv ntawm GMP thiab cGMP yog dab tsi?
Cov Kev Cai Tsim Khoom Zoo (GMP) thiab Cov Kev Cai Tsim Khoom Zoo tam sim no (cGMP) feem ntau yog sib pauv tau. GMP yog txoj cai tswjfwm yooj yim uas tau tshaj tawm los ntawm US Food and Drug Administration (FDA) raws li txoj cai ntawm Federal Food, Drug, thiab Cosmetic Act kom ntseeg tau tias cov chaw tsim khoom tab tom ua cov kauj ruam ua ntej kom ntseeg tau tias lawv cov khoom muaj kev nyab xeeb thiab ua tau zoo. cGMP, ntawm qhov tod tes, tau siv los ntawm FDA los xyuas kom meej tias kev txhim kho tas mus li hauv txoj hauv kev ntawm cov chaw tsim khoom mus rau qhov zoo ntawm cov khoom. Nws txhais tau tias kev cog lus tas mus li rau cov qauv zoo tshaj plaws los ntawm kev siv cov txheej txheem thiab cov thev naus laus zis tshiab.
5 Lub Ntsiab Lus Tseem Ceeb ntawm Kev Ua Haujlwm Zoo Hauv Kev Tsim Khoom yog dab tsi?
Nws yog qhov tseem ceeb rau kev lag luam tsim khoom los tswj hwm GMP hauv chaw ua haujlwm kom ntseeg tau tias cov khoom zoo thiab kev nyab xeeb. Kev tsom mus rau 5 P ntawm GMP hauv qab no pab ua raws li cov qauv nruj thoob plaws hauv cov txheej txheem tsim khoom.
5 yam tseem ceeb ntawm GMP
1. Cov Neeg
Txhua tus neeg ua haujlwm yuav tsum ua raws li cov txheej txheem tsim khoom thiab cov cai. Txhua tus neeg ua haujlwm yuav tsum tau kawm GMP kom nkag siab txog lawv lub luag haujlwm thiab lub luag haujlwm. Kev soj ntsuam lawv cov kev ua tau zoo pab txhawb lawv txoj kev tsim khoom, kev ua haujlwm zoo, thiab kev txawj ntse.
2. Cov Khoom
Txhua yam khoom yuav tsum tau kuaj xyuas tas li, sib piv, thiab paub tseeb tias zoo ua ntej muab faib rau cov neeg siv khoom. Cov chaw tsim khoom yuav tsum xyuas kom meej tias cov khoom siv tseem ceeb suav nrog cov khoom nyoos thiab lwm yam khoom muaj cov lus qhia meej ntawm txhua theem ntawm kev tsim khoom. Yuav tsum ua raws li tus qauv txheej txheem rau kev ntim khoom, kev sim, thiab kev faib cov khoom piv txwv.
3. Cov Txheej Txheem
Cov txheej txheem yuav tsum tau sau tseg kom raug, meej, sib xws, thiab faib rau txhua tus neeg ua haujlwm. Yuav tsum tau ua kev ntsuam xyuas tsis tu ncua kom ntseeg tau tias txhua tus neeg ua haujlwm ua raws li cov txheej txheem tam sim no thiab ua tau raws li cov qauv tsim nyog ntawm lub koom haum.
4. Cov txheej txheem
Ib txoj kev ua haujlwm yog ib pawg lus qhia rau kev ua ib txoj haujlwm tseem ceeb lossis ib feem ntawm ib txoj haujlwm kom ua tiav qhov tshwm sim zoo sib xws. Yuav tsum tau muab tso rau txhua tus neeg ua haujlwm thiab ua raws li tas li. Txhua qhov kev hloov pauv ntawm tus txheej txheem tus qauv yuav tsum tau tshaj tawm tam sim ntawd thiab tshawb xyuas.
5. Chaw Nyob
Yuav tsum txhawb kom muaj kev huv si txhua lub sijhawm kom tsis txhob muaj kev sib kis, kev raug mob, lossis kev tuag. Txhua yam khoom siv yuav tsum tau muab tso rau lossis khaws cia kom zoo thiab kho kom zoo tsis tu ncua kom ntseeg tau tias lawv haum rau lub hom phiaj ntawm kev tsim cov txiaj ntsig zoo sib xws kom tiv thaiv kev pheej hmoo ntawm kev ua tsis tiav ntawm cov khoom siv.
10 Lub Ntsiab Cai ntawm GMP yog dab tsi?
1. Tsim Cov Txheej Txheem Ua Haujlwm Txheem (SOPs)
2. Siv / Siv SOPs thiab cov lus qhia ua haujlwm
3. Cov txheej txheem thiab cov txheej txheem sau tseg
4. Txheeb xyuas seb cov SOPs ua haujlwm tau zoo li cas
5. Tsim thiab siv cov txheej txheem ua haujlwm
6. Tswj cov txheej txheem, cov chaw, thiab cov khoom siv
7. Txhim kho kev txawj ua haujlwm ntawm cov neeg ua haujlwm
8. Tiv thaiv kom tsis txhob muaj kuab paug los ntawm kev ua kom huv si
9. Muab qhov tseem ceeb rau qhov zoo thiab koom ua ke rau hauv cov txheej txheem ua haujlwm
10. Ua kev tshuaj xyuas GMP tsis tu ncua
Yuav Ua Li Cas Thiaj Ua Tau Raws Li GTus qauv MP
Cov lus qhia thiab cov cai ntawm GMP daws teeb meem sib txawv uas tuaj yeem cuam tshuam rau kev nyab xeeb thiab qhov zoo ntawm cov khoom. Kev ua tau raws li cov qauv GMP lossis cGMP pab lub koom haum ua raws li cov lus txib ntawm cov neeg tsim cai lij choj, ua kom zoo dua ntawm lawv cov khoom, txhim kho kev txaus siab ntawm cov neeg siv khoom, nce kev muag khoom, thiab khwv tau txiaj ntsig ntawm kev nqis peev.
Kev ua cov kev tshuaj xyuas GMP ua lub luag haujlwm tseem ceeb hauv kev ntsuam xyuas seb lub koom haum puas ua raws li cov txheej txheem tsim khoom thiab cov lus qhia. Kev ua cov kev tshuaj xyuas tsis tu ncua tuaj yeem txo qhov kev pheej hmoo ntawm kev ua qias tuaj thiab kev tsim khoom tsis raug. Kev tshuaj xyuas GMP pab txhim kho kev ua tau zoo ntawm ntau lub tshuab suav nrog cov hauv qab no:
· Lub tsev thiab cov chaw
· Kev tswj cov khoom siv
· Cov txheej txheem tswj xyuas zoo
· Kev Tsim Khoom
· Kev ntim khoom thiab kev cim qhia tus kheej
· Cov txheej txheem tswj xyuas zoo
· Kev cob qhia neeg ua haujlwm thiab GMP
Kev Yuav Khoom
· Kev pabcuam rau cov neeg siv khoom
Lub sijhawm tshaj tawm: Lub Peb Hlis-29-2023