Khoom noj khoom haus GMP ntawv pov thawj tau pib los ntawm Tebchaws Meskas hauv xyoo 1960, uas txhais tau hais tias kev tsim khoom zoo. Lub Koom Haum Saib Xyuas Kev Noj Qab Haus Huv (World Health Organization) txhais GMP raws li cov cai tswj hwm kev tsim khoom thiab kev tswj hwm zoo ntawm cov zaub mov, tshuaj thiab cov khoom siv kho mob.
GMP yog cov txheej txheem tsim nyog siv rau kev lag luam tshuaj, khoom noj khoom haus thiab lwm yam lag luam, yuav tsum muaj kev lag luam los ntawm cov khoom siv raw, cov neeg ua haujlwm, cov khoom siv thiab cov khoom siv, cov txheej txheem tsim khoom, ntim thiab kev thauj mus los, kev tswj kom zoo thiab lwm yam raws li cov kev cai hauv lub tebchaws kom tau raws li kev noj qab haus huv. cov kev xav tau zoo, tsim cov txheej txheem ntawm kev ua haujlwm los pab cov tuam txhab txhim kho kev noj qab haus huv ntawm cov tuam txhab, tshawb pom cov teeb meem raws sijhawm hauv cov txheej txheem tsim khoom, txhim kho. Nyob rau hauv luv luv, GMP yuav tsum tau muab tshuaj, khoom noj khoom haus thiab lwm yam kev lag luam yuav tsum muaj cov khoom siv zoo, tsim nyog cov txheej txheem, zoo meej tswj thiab nruj soj ntsuam system kom paub tseeb tias qhov zoo ntawm cov khoom kawg (xws li zaub mov kev nyab xeeb thiab huv si) raws li cov kev cai ntawm kev cai. . Tshuaj GMP daim ntawv pov thawj yog ib qho system rau lub xeev los siv GMP kev saib xyuas thiab tshuaj xyuas ntawm cov chaw tsim tshuaj (rhiav) thiab cov tshuaj ntau yam thiab tau txais kev lees paub. Txawm hais tias lub tswv yim thoob ntiaj teb ntawm cov tshuaj suav nrog cov tshuaj kho tsiaj, tsuas yog ob peb lub tebchaws, xws li Tuam Tshoj thiab Australia, cais GMP rau tib neeg siv thiab tshuaj kho tsiaj.
Dab tsi yog GMP ntsig txog FAT, SAT, DQ, IQ, OQ, PQ pov thawj? Vim li cas thiaj tsim nyog?
Hauv kev lag luam biopharmaceutical, kev ua zaub mov thiab kev tshawb fawb tshawb fawb, pulverized npaj cov kab ntau lawm yog ib qho tseem ceeb ntawm kev ua, thiab cov txheej txheem pov thawj ntawm nws cov cuab yeej tseem ceeb heev. Cov txheej txheem no tsis tsuas yog ua kom muaj kev ruaj ntseg thiab kev nyab xeeb ntawm cov khoom zoo, tab sis kuj ua raws li cov kev cai nruj ntawm thoob ntiaj teb GMP (Good Manufacturing Practice) thiab cov qauv kev lag luam. FAT (Lub Hoobkas Txais Kev Xeem), SAT (Qhov Chaw Pom Zoo),
DQ (Design Qualification) IQ (Installation Qualification), OQ (Operational Qualification) thiab PQ (Performance Qualification) pov thawj, Tsib qhov txuas tseem ceeb yog qhov tseem ceeb hauv cov txheej txheem no.
FAT (Factory Acceptance Test): Lub Hoobkas lees txais
FAT yog thawj qhov kev sim ua tiav nyob rau hauv lub Hoobkas ntawm cov chaw tsim khoom ntawm cov khoom sib tsoo kom paub tseeb tias cov cuab yeej ua tau raws li cov txheej txheem tsim thiab cov qauv zoo thaum lub sijhawm tsim thiab tsim khoom. Cov theem no suav nrog kev tshuaj xyuas kev siv tshuab, kev ntsuas hluav taws xob kev nyab xeeb, kev tswj xyuas qhov tseeb thiab kev ntsuas kev ua haujlwm kom ntseeg tau tias cov cuab yeej ua tau raws li qhov yuav tsum tau ua ua ntej tawm hauv lub hoobkas. Kev ua tiav ntawm FAT yog qhov yuav tsum tau ua ua ntej rau kev xa khoom zoo thiab kev ua haujlwm ntawm cov khoom siv, txo cov teeb meem tom qab los ntawm cov khoom siv tsis raug.
SAT (Site Acceptance Test): qhov chaw txais kev xeem
SAT ua raws FAT tom qab cov khoom tau raug xa mus rau cov neeg siv khoom thiab teeb tsa. Cov kauj ruam no yog txhawm rau xyuas seb lub cuab yeej puas puas thaum lub sijhawm thauj mus los thiab kev teeb tsa, thiab xyuas kom meej tias qhov chaw teeb tsa ntawm qhov chaw, xws li cov khoom siv hluav taws xob thiab kev tswj hwm ib puag ncig, ua tau raws li cov khoom siv uas yuav tsum tau ua. SAT kuj tseem suav nrog kev rov siv tau ntawm cov haujlwm tseem ceeb ntawm lub cuab yeej los xyuas kom meej tias nws tseem tuaj yeem ua haujlwm tau zoo hauv qhov chaw ua haujlwm tshiab, tso lub hauv paus rau tom qab IQ, OQ, thiab PQ pov thawj.
DQ (Design Qualification): Tsim nyog tsim nyog
DQ theem yog ua tiav ua ntej kev yuav khoom, lub hom phiaj yog xaiv cov cuab yeej raws li nws tus kheej xav tau, thiab paub meej tias cov cuab yeej tsim tau raws li qhov xav tau ntawm kev siv thiab cov kev xav tau ntawm GMP (Kev tsim khoom zoo rau kev siv tshuaj. cov khoom). Cov txheej txheem no suav nrog kev tshuaj xyuas zoo thiab kev ntsuam xyuas ntawm cov cuab yeej tsim los xyuas kom meej tias nws tuaj yeem ua tau raws li cov qauv kev xav tau thiab kev siv.
Hauv kev lag luam kws tshuaj, DQ validation yog ib qho tseem ceeb tshwj xeeb vim nws muaj feem cuam tshuam ncaj qha rau seb lub cuab yeej puas tuaj yeem ua tau raws li cov kev xav tau tshwj xeeb thiab cov qauv ntawm kev tsim tshuaj. Los ntawm DQ pov thawj, koj tuaj yeem ua kom ntseeg tau tias qhov tsim ntawm cov khoom xaiv tuaj yeem txhawb nqa cov txheej txheem tsim khoom tom ntej, yog li lav qhov zoo thiab kev nyab xeeb ntawm cov khoom. Tsis tas li ntawd, kev kuaj xyuas DQ tseem yog lub hauv paus ntawm tag nrho cov txheej txheem pov thawj, muab lub hauv paus ruaj khov thiab cov kev taw qhia meej rau qib tom ntej IQ, OQ thiab PQ.
IQ (Installation Qualification): installation tsim nyog
IQ yog ib qho kev lees paub ntawm lub tshuab ziab khaub ncaws kom qhuav txheej txheem thiab kev teeb tsa ib puag ncig. Nws suav nrog kev tshuaj xyuas cov ntaub ntawv kev teeb tsa cov cuab yeej, kev lees paub ntawm qhov chaw teeb tsa, kev tshuaj xyuas cov khoom siv hluav taws xob thiab hauv av, thiab kev txheeb xyuas qhov tseeb thiab kev txheeb xyuas cov khoom siv. Lub hom phiaj ntawm IQ yog los xyuas kom meej tias cov cuab yeej tau raug teeb tsa kom raug raws li cov chaw tsim khoom thiab cov neeg siv khoom qhov chaw, muab lub hauv paus rau kev ua haujlwm tom qab thiab kev ua haujlwm ntawm cov khoom siv.
Kev Tsim Nyog Ua Haujlwm (OQ): Kev tsim nyog ua haujlwm
Nyob rau hauv OQ theem, lub hom phiaj yog txhawm rau txheeb xyuas lub peev xwm ntawm lub tshuab ziab khaub ncaws kom ua haujlwm raws li kev ua haujlwm ua ntej. Qhov no suav nrog kev soj ntsuam kev ua haujlwm xws li pib, nres thiab kaw thaum muaj xwm txheej ceev ntawm cov cuab yeej siv, nrog rau kev txheeb xyuas cov khoom tseem ceeb xws li kev tswj hwm, sensors thiab lub tswb nrov. OQ simulates cov xwm txheej ua haujlwm hauv cov txheej txheem tsim khoom tiag tiag los xyuas kom meej tias cov khoom siv tuaj yeem ua haujlwm raws li qhov xav tau thiab ua tau raws li qhov yuav tsum tau ua.
PQ (Performance Qualification): Kev ua tau zoo
PQ yog cov kauj ruam tseem ceeb tshaj plaws nyob rau hauv cov txheej txheem validation, uas ncaj qha soj ntsuam cov kev ua tau zoo ntawm cov pulverized npaj kab nyob rau hauv tej yam kev mob ntawm ntau lawm thiab cov conformity ntawm cov khoom zoo. PQ feem ntau cuam tshuam nrog kev ua haujlwm ntawm ntau lub voj voog ntau lawm, saib xyuas thiab kaw cov kev hloov pauv hauv cov txheej txheem tseem ceeb (xws li qhov kub, siab, lub sijhawm), thiab kev tshawb nrhiav cov khoom zoo (xws li cov tsos, cov ntsiab lus dej, cov ntsiab lus tseem ceeb, thiab lwm yam). Kev ua tiav ntawm PQ qhia tau hais tias tag nrho cov kev sib tsoo tshuab hauv cov kab ntau lawm tau ua tiav raws li cov qauv tsim, thiab tuaj yeem siv tau ruaj khov thiab ntseeg tau los tsim cov khoom zoo.
Cov txheej txheem pov thawj no ua ke tsim kom muaj kev tswj xyuas zoo los ntawm lub Hoobkas mus rau kev siv cov cuab yeej siv, ua kom cov haujlwm ruaj khov thiab muaj txiaj ntsig zoo ntawm cov khoom sib tsoo cov kab thoob plaws hauv lub neej. Los ntawm kev txheeb xyuas nruj, cov lag luam tuaj yeem txo qhov kev pheej hmoo ntawm kev cuam tshuam ntau lawm los ntawm cov khoom siv tsis ua haujlwm, txhim kho cov khoom lag luam zoo, txhim kho cov neeg siv khoom ntseeg siab, thiab yog li tuav txoj haujlwm zoo hauv kev sib tw ua lag luam hnyav. Nyob rau tib lub sijhawm, nws kuj ua tau raws li cov kev cai nruj nruj rau qhov zoo thiab kev nyab xeeb ntawm cov tshuaj, khoom noj thiab lwm yam khoom thoob ntiaj teb, uas yog ib qho tseem ceeb lav rau kev txhim kho kev lag luam. Peb Fangyuan Machinery sib tsoo npaj cov kab ntau lawm tau ua raws li qhov yuav tsum tau ua ntawm GMP cov lus qhia tshwj xeeb, thiab zoo kawg nkaus txhawb nqa "4Q" kev lees paub.
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