Tsis yog-GLP kev tshawb fawb kws tshuaj ua lub luag haujlwm tseem ceeb hauv kev txhim kho tshuaj thaum ntxov los ntawm kev muab cov pov thawj ua ntej ntawm kev ua tau zoo thiab cov txheej txheem ntawm kev ua. Txawm hais tias cov kev tshawb fawb no tsis tau ua raws li kev ua raws li Kev Ua Haujlwm Zoo (GLP) tag nrho, lawv cov ntaub ntawv feem ntau suav nrog hauv cov ntawv tso cai. Yog li ntawd, qhov tseem ceeb yuav tsum tsis yog daim ntawv pov thawj, tab sis kev tshawb fawb kev ntseeg siab, cov ntaub ntawv ncaj ncees, thiab traceability.
Hauv kev xyaum, tsis yog -GLP cov kev tshawb fawb yuav tsum ua raws li Txoj Cai Zoo Kev Tshawb Fawb (GSP) kom ntseeg tau tias cov txiaj ntsig tau ntseeg tau, rov tsim dua, thiab lees txais rau cov cai tswj hwm.
Laboratory Requirements: Controlled, Not Unregulated
Tsis yog-GLP cov kev tshawb fawb tsis tas yuav tsum muaj GLP- cov chaw muaj ntawv pov thawj lossis Cov Chaw Pov Hwm Zoo (QAU). Txawm li cas los xij, qhov chaw sim yuav tsum tau tswj xyuas kom ntseeg tau cov ntaub ntawv.
Ib qho kev lees paub kev kuaj mob feem ntau suav nrog:
Tswj tej chaw thiab ib puag ncig
Cov chaw tsiaj yuav tsum ua haujlwm raws li daim ntawv tso cai tsim nyog (piv txwv li, SPF- qib vivariums), nrog rau ib puag ncig tsis xws li kub, av noo, lub voj voog lub teeb, thiab qhov sib txawv ntawm qhov ntsuas thiab kaw. Cov kev tswj no txo qis qhov sib txawv thiab tiv thaiv kev kawm ncaj ncees.
Cov cuab yeej Calibration thiab tu
Cov cuab yeej tseem ceeb-nrog rau qhov sib npaug, centrifuges, microplate nyeem ntawv, thiab kev siv tshuaj noj- yuav tsum tau ua raws li niaj hnub calibration thiab tu. Cov ntaub ntawv yuav tsum tau khaws cia kom pom qhov ntsuas qhov tseeb thiab kev ntseeg tau ntawm kev ua haujlwm.
Kev Tswj Xyuas Cov Cai
Lub cev muaj zog yuav tsum nyob rau hauv qhov chaw rau daim ntawv txais nyiaj, khaws cia, npaj, thiab siv cov khoom xeem (piv txwv li, me me molecules, biologics, PROTACs). Cov yam ntxwv tseem ceeb xws li batch naj npawb, purity, stability, thiab concentration yuav tsum yog tag nrho traceable kom paub meej dosing raug.
Cov Neeg Ua Haujlwm Tsim Nyog
Kev kawm ua tiav yuav tsum tau ua los ntawm cov neeg ua haujlwm cob qhia nrog cov keeb kwm kev tshawb fawb. Kev sib raug zoo hauv cov txheej txheem kev sim yog qhov tseem ceeb los txo qhov kev hloov pauv thiab ua kom muaj kev rov tsim dua tshiab.
Cov Ntaub Ntawv Teev Tseg: ALCOA + Txoj Cai
Kev lees txais ntawm cov ntaub ntawv tsis yog -GLP rau kev tswj hwm lub hom phiaj feem ntau nyob ntawm cov ntaub ntawv kev ncaj ncees, feem ntau txhais los ntawm ALCOA + lub moj khaum:
- Tsim nyog- Txhua qhov chaw cov ntaub ntawv yuav tsum tau traceable rau tus neeg uas tsim nws.
- Muaj cai- Cov ntaub ntawv yuav tsum meej, ruaj khov, thiab nyeem tau.
- Niaj hnub nimno- Cov ntaub ntawv yuav tsum tau sau tseg hauv lub sijhawm tiag tiag thaum lub sijhawm sim.
- Keeb kwm- Cov ntaub ntawv qub (lossis cov ntawv pov thawj) yuav tsum khaws cia.
- Muaj tseeb- Cov ntaub ntawv yuav tsum cuam tshuam qhov kev soj ntsuam tiag tiag yam tsis muaj kev tswj hwm.
Qhov "+" txuas ntxiv rau cov kev xav tau ntxiv:
- Ua kom tiav- Txhua cov ntaub ntawv, suav nrog kev sib txawv thiab qhov tsis sib xws, yuav tsum tau khaws cia.
- Zoo ib yam- Cov ntaub ntawv yuav tsum ua raws li qhov kev xav tau thiab sijhawm ua ntu zus.
- Kev ruaj khov- Cov ntaub ntawv yuav tsum tau khaws cia rau hauv cov qauv ruaj khov.
- Muaj- Cov ntaub ntawv yuav tsum nkag mus tau yooj yim rau kev tshuaj xyuas thiab tshuaj xyuas.
Cov ntsiab cai no yog qhov tseem ceeb rau kev ua kom pom tias tsis yog -GLP cov ntaub ntawv muaj kev ntseeg siab thiab tsim nyog rau kev suav nrog hauv cov ntaub ntawv tswj hwm.
Cov Txheej Txheem Tswjhwm: Cov Txheej Txheem thiab Deviations
Tshaj li kev tsim kho vaj tse thiab kev sau cov ntaub ntawv, cov txheej txheem nruj yog qhov tseem ceeb sib npaug.
Kawm raws tu qauv
Txhua txoj kev tshawb fawb yuav tsum pib nrog kev pom zoo sau raws tu qauv qhia txog lub hom phiaj, kev kawm tsim, tsiaj qauv, kev siv tshuaj, cov ntsiab lus kawg, thiab cov txheej txheem txheeb cais. Cov ntaub ntawv no yog lub hauv paus rau txhua yam kev sim.
Deviation Management
Ib qho kev sib txawv ntawm cov txheej txheem- xws li kev siv tshuaj tsis raug lossis cov txiaj ntsig ntawm cov tsiaj tsis tau xav txog- yuav tsum tau sau tseg kom pom tseeb, suav nrog qhov ua rau thiab muaj feem cuam tshuam rau kev tshawb fawb. Kev pom kev pom tseeb yog qhov tseem ceeb rau kev lees paub.
Kev tsis sib haum xeeb -GLP Kev Kawm rau Kev Cai Xa Ntawv
Txhawm rau kom ntseeg tau tias tsis yog -GLP cov ntaub ntawv tshuaj kho mob tuaj yeem pab txhawb kev xa ntawv, cov kev tshawb fawb yuav tsum ua kom pom:
- Kev ua tiav hauv kev tswj hwm thiab zoo -cov ntaub ntawv hauv chav kuaj ib puag ncig
- Kev nruj nruj rau cov txheej txheem ua ntej
- Tiag - sijhawm, raug, thiab ua tiav cov ntaub ntawv kaw
- Tag nrho traceability ntawm tag nrho cov txheej txheem sim thiab cov ntaub ntawv
- Txhim kho cov ntaub ntawv raw, cov ntaub ntawv tawm, thiab cov ntaub ntawv txhawb nqa
Hauv qhov tseem ceeb, tsis yog -GLP tsis hais txog cov qauv qis dua- nws yuav tsum muaj cov txheej txheem sib txawv uas qhov kev tshawb fawb nruj hloov cov qauv kev ua raws cai.
Yuav ua li cas Prisys Biotech txhawb siab -Quality Non-GLP Pharmacology Studies
Prisys Biotech muab kev txhawb nqa ua ke los xyuas kom meej tias tsis yog -GLP kev tshawb fawb tshuaj raws li kev tswj hwm kev cia siab thaum tswj kev hloov pauv thaum ntxov- kev tshawb fawb theem.
Nrog rau kev tsom ntsoov rautsis yog-neeg primate (NHP) txhais cov qauv, Prisys muaj lub platform tshwj xeeb uas txhim kho tus nqi kwv yees ntawm cov ntaub ntawv tshuaj:
Prisys ua haujlwm AAALAC-cov chaw raug lees paub thiab tswj hwm thaj chaw vivarium, kom ntseeg tau cov qauv siab ntawm kev noj qab haus huv tsiaj thiab kev sim sib xws. Nws infrastructure suav nrogadvanced imaging systems(MRI, CT, PET-CT), kev phais suites, thiab biosafety lub chaw soj nstuam, ua rau muaj kev nyuaj hauv vivo cov kev tshawb fawb tshuaj raws li kev kho mob.
Lub tuam txhab cov kws tshaj lij nthuav dav ntau thaj chaw kho mob- suav nrog CNS, ua pa, tiv thaiv kab mob, thiab hematology- txhawb nqa los ntawm zoo- qauv kab mob NHP. Cov qauv no tso cai rau kev tshuaj ntsuam xyuas kev ua tau zoo dua qub piv rau cov kab ke ib txwm muaj.
Hauv tsis yog -GLP teeb tsa, Prisys hais txog:
- Cov txheej txheem nruj tsim raws li kev tswj hwm kev cia siab
- Tag nrho traceability ntawm cov ntawv xeem thiab cov ntaub ntawv sim
- Kev koom ua ke ntawm cov duab, PK / PD, thiab biomarker kawg
- Kev paub txog kev tshawb fawb pab pawg kom ntseeg tau tias kev ua tiav
Los ntawm kev sib koom ua ke kev tshawb fawb nruj nrog kev txhais lus, Prisys pab txuas cov kev tshawb fawb tshuaj thaum ntxov rau IND-ua kom muaj tswv yim thiab kev txiav txim siab kho mob- ua.
Xaus
Tsis yog-GLP kev tshawb fawb kws tshuaj yog lub hauv paus ntawm kev txhim kho tshuaj thaum ntxov. Thaum lawv ua haujlwm sab nraud GLP cov txheej txheem, lawv cov nqi yog nyob ntawm kev ua raws li Kev Ua Haujlwm Zoo, cov ntaub ntawv muaj kev ncaj ncees, thiab cov ntaub ntawv pob tshab.
Thaum ua tau zoo, tsis yog -GLP cov kev tshawb fawb tuaj yeem tsim tau siab -zoo, kev tswj hwm- cov ntaub ntawv lees paub uas de- kev pheej hmoo loj hlob thiab txhawb kev txiav txim siab tseem ceeb- ua.
FAQ
Q: Puas tuaj yeem tsis yog -GLP kev tshawb fawb tshuaj kho mob tuaj yeem siv rau hauv cov ntawv tso cai?
A: Yog. Cov koom haum tswj hwm lees txais cov ntaub ntawv uas tsis yog -GLP cov ntaub ntawv tshuaj yog tias cov kev tshawb fawb pom tau tias muaj kev tshawb fawb muaj txiaj ntsig zoo, tsim qauv zoo, thiab ua raws li cov ntaub ntawv kev ncaj ncees xws li ALCOA+.
Q: Dab tsi yog qhov txawv ntawm GLP thiab tsis yog -GLP kev tshawb fawb?
A: Kev tshawb fawb GLP yuav tsum tau ua raws li kev cai lij choj, suav nrog QA kev saib xyuas thiab cov txheej txheem txheem. Tsis yog-GLP cov kev tshawb fawb tau hloov pauv tau yooj yim dua tab sis yuav tsum tseem muaj kev tshawb fawb nruj, kev taug qab, thiab cov ntaub ntawv ntseeg tau.
Q: Vim li cas NHP cov qauv tseem ceeb hauv cov kev tshawb fawb tsis yog {{0}GLP pharmacology?
A: Tsis yog- tib neeg primates muab siab physiological thiab caj ces zoo sib xws rau tib neeg, txhim kho kev txhais lus muaj feem xyuam. Qhov no tso cai rau tsis yog-GLP cov ntaub ntawv ua tau zoo rau kev kwv yees cov txiaj ntsig kho mob zoo dua thiab txhawb kev txiav txim siab- ua.
