Eduard Marty ntawm Codols piav qhia tias cov khoom siv tshuaj thiab cov khoom siv ntxuav hauv chaw kuaj mob muaj cov yam ntxwv tsim tshwj xeeb uas cov chaw tsim khoom yuav tsum paub txog kom ntseeg tau tias ua raws li txoj cai.
Cov chaw tsim khoom siv ua raws li cov qauv nruj thaum tsim thiab tsim cov tshuab ntxuav rau kev lag luam tshuaj. Qhov kev tsim no tseem ceeb vim tias muaj ntau yam ntxwv los ua raws li Kev Ua Zoo Hauv Kev Tsim Khoom (GMP khoom siv) thiab Kev Ua Zoo Hauv Chaw Kuaj Mob (GLP khoom siv).
Ua ib feem ntawm kev lees paub zoo, GMP yuav tsum ua kom ntseeg tau tias cov khoom tsim tawm raws li tus qauv zoo thiab tswj tau raws li qhov xav tau ntawm cov khoom siv thiab raws li cov xwm txheej tsim nyog rau kev lag luam. Tus neeg tsim khoom yuav tsum tswj txhua yam uas yuav cuam tshuam rau qhov zoo ntawm cov tshuaj, nrog rau lub hom phiaj tseem ceeb ntawm kev txo qhov kev pheej hmoo hauv kev tsim cov tshuaj tag nrho.
Cov cai GMP yog qhov yuav tsum muaj rau txhua tus neeg tsim tshuaj. Rau cov khoom siv GMP, cov txheej txheem muaj cov hom phiaj tshwj xeeb ntxiv:
Muaj ntau hom kev ntxuav: ntxuav tes, ntxuav hauv qhov chaw (CIP) thiab cov khoom siv tshwj xeeb. Tsab xov xwm no piv kev ntxuav tes rau kev ntxuav nrog cov khoom siv GMP.
Txawm hais tias kev ntxuav tes muaj qhov zoo ntawm kev ua tau ntau yam, muaj ntau yam tsis yooj yim xws li lub sijhawm ntxuav ntev, cov nqi kho siab, thiab qhov nyuaj hauv kev rov kuaj dua.
Lub tshuab ntxhua khaub ncaws GMP xav tau kev nqis peev thawj zaug, tab sis qhov zoo ntawm cov khoom siv yog tias nws yooj yim rau kev sim thiab yog cov txheej txheem rov ua dua thiab tsim nyog rau txhua yam cuab yeej, pob khoom thiab cov khoom. Cov yam ntxwv no tso cai rau koj kom ua kom huv si, txuag lub sijhawm thiab nyiaj txiag.
Cov tshuab ntxuav tsis siv neeg siv rau hauv kev tshawb fawb thiab cov chaw tsim tshuaj los ntxuav ntau yam khoom. Cov tshuab ntxhua khaub ncaws siv dej, tshuaj ntxuav tes thiab kev siv tshuab los ntxuav cov chaw ntawm cov khib nyiab hauv chaw kuaj mob thiab cov khoom lag luam.
Muaj ntau lub tshuab ntxhua khaub ncaws rau ntau yam kev siv hauv khw, ntau lo lus nug tshwm sim: Lub tshuab ntxhua khaub ncaws GMP yog dab tsi? Thaum twg kuv xav tau kev ntxuav tes thiab thaum twg kuv xav tau kev ntxuav GMP? Qhov txawv ntawm GMP thiab GLP gaskets yog dab tsi?
Lub Npe 21, Ntu 211 thiab 212 ntawm Cov Cai ntawm Tsoom Fwv Teb Chaws Asmeskas (CFR) ntawm US Food and Drug Administration txhais cov qauv kev cai lij choj uas siv rau kev ua raws li GMP rau cov tshuaj. Ntu D ntawm Ntu 211 suav nrog tsib ntu ntawm cov khoom siv thiab tshuab, suav nrog cov gaskets.
21 CFR Ntu 11 kuj yuav tsum tau txiav txim siab raws li nws cuam tshuam txog kev siv cov thev naus laus zis hluav taws xob. Nws muab faib ua ob ntu tseem ceeb: kev sau npe hluav taws xob thiab kos npe hluav taws xob.
Cov cai ntawm FDA rau kev tsim thiab tsim cov khoom siv yuav tsum ua raws li cov lus qhia hauv qab no:
Qhov sib txawv ntawm GMP thiab GLP tshuab ntxhua khaub ncaws tuaj yeem muab faib ua ntau yam, tab sis qhov tseem ceeb tshaj plaws yog lawv cov qauv tsim kho tshuab, cov ntaub ntawv sau tseg, nrog rau software, automation thiab kev tswj cov txheej txheem. saib lub rooj.
Rau kev siv kom raug, cov tshuab ntxhua khaub ncaws GMP yuav tsum tau teev tseg kom raug, zam kev xav tau siab dua lossis cov uas tsis ua raws li cov qauv kev cai. Yog li ntawd, nws yog ib qho tseem ceeb kom muab cov Lus Qhia Txog Kev Xav Tau Tus Neeg Siv (URS) rau txhua qhov project.
Cov lus qhia tshwj xeeb yuav tsum piav qhia txog cov qauv uas yuav tsum tau ua tiav, kev tsim kho tshuab, kev tswj cov txheej txheem, software thiab cov txheej txheem tswj, thiab cov ntaub ntawv xav tau. Cov lus qhia GMP yuav tsum tau kom cov tuam txhab ua qhov kev ntsuam xyuas kev pheej hmoo los pab txheeb xyuas cov tshuab ntxhua khaub ncaws uas tsim nyog uas ua tau raws li cov kev cai uas tau teev tseg lawm.
GMP Gaskets: Txhua qhov clamp fitting yog FDA pom zoo thiab txhua lub kav dej yog AISI 316L thiab tuaj yeem ntws tawm. Muab daim duab qhia txog kev txuas hluav taws xob thiab cov qauv tiav raws li GAMP5. Lub trolleys lossis racks sab hauv ntawm GMP washer yog tsim rau txhua hom khoom siv, piv txwv li cov khoom siv, cov tank, cov thawv, cov khoom siv hauv kab fwj, iav, thiab lwm yam.
GPL Gaskets: Tsim los ntawm kev sib xyaw ua ke ntawm cov khoom txheem uas tau pom zoo ib nrab, cov yeeb nkab khov kho thiab yoog tau, cov xov thiab ntau hom gaskets. Tsis yog txhua cov yeeb nkab tuaj yeem ntws tawm thiab lawv cov qauv tsim tsis ua raws li GAMP 5. Lub tshuab ntxhua khaub ncaws GLP sab hauv yog tsim los rau txhua hom khoom siv hauv chaw kuaj mob.
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