GMP Certification thiab GMP Management System

GMP yog dab tsi?

GMP-Kev tsim khoom zoo

Nws tseem tuaj yeem hu ua Current Good Manufacturing Practice (cGMP).

Kev Ua Zoo Zoo yog xa mus rau cov kev cai lij choj thiab cov kev cai ntawm kev tsim khoom thiab kev tswj xyuas zoo ntawm cov khoom noj, tshuaj thiab cov khoom siv kho mob.Nws xav kom cov tuam txhab ua kom tau raws li cov kev cai huv huv ntawm cov khoom siv raw, cov neeg ua haujlwm, cov chaw 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 thiab cov kev cai, tsim cov txheej txheem ntawm kev ua haujlwm tshwj xeeb los pab cov tuam txhab txhim kho kev huv huv ntawm cov tuam txhab, thiab nrhiav teeb meem hauv cov txheej txheem tsim khoom hauv lub sijhawm txhim kho.

Qhov sib txawv ntawm Tuam Tshoj thiab lwm lub teb chaws hauv ntiaj teb no yog tias tib neeg kev siv tshuaj thiab kev siv tshuaj kho tsiaj txawv hauv Suav teb, uas siv tib neeg cov tshuaj siv GMP thiab cov tshuaj tua tsiaj GMP.Txij li thaum siv tshuaj GMP ntawv pov thawj hauv Suav teb, nws tau raug kho dua. nyob rau hauv 2010 thiab officially siv lub tshiab version ntawm GMP nyob rau hauv 2011.Qhov tshiab version ntawm GMP ntawv pov thawj tso rau pem hauv ntej siab yuav tsum tau rau zus tau tej cov sterile npaj thiab APIs.

Yog li vim li cas ntau lub chaw tsim tshuaj yuav tsum dhau GMP daim ntawv pov thawj?

Cov neeg tsim khoom lossis cov chaw lag luam nrog GMP ntawv pov thawj tau txais kev saib xyuas nruj los ntawm cov tuam haujlwm hauv lub tebchaws hauv cov txheej txheem xws li kev tsim khoom thiab kev sim.Rau cov neeg siv khoom, nws yog ib qho teeb meem los tswj cov khoom zoo, thiab nws kuj yog kev tiv thaiv rau cov lag luam lawv tus kheej, kom lawv cov khoom muaj tus txheej txheem los tswj cov khoom zoo.

Cov lag luam nrog GMP daim ntawv pov thawj yuav tsum tsim kom muaj GMP kev tswj hwm kev ua haujlwm kom ntseeg tau tias kev ncaj ncees thiab kev ua tau zoo ntawm kev lag luam zoo, vim tias lub tuam txhab tseem tau txais GMP kev tshuaj xyuas los ntawm National Food and Drug Administration txhua tsib xyoos los xyuas tag nrho cov ntaub ntawv GMP thiab cov kev khiav hauj lwm cuam tshuam. cov ntaub ntawv keeb kwm ntawm kev lag luam hauv tsib xyoos dhau los.

Raws li lub Hoobkas GMP,Handeua raws li kev tswj hwm nruj raws li qhov yuav tsum tau ua ntawm cGMP thiab cov ntaub ntawv tswj xyuas zoo tam sim no.Lub Chaw Saib Xyuas Kev Nyab Xeeb Zoo saib xyuas kev ua haujlwm zoo hauv txhua lub tuam tsev, thiab txuas ntxiv txhim kho thiab ua tiav lub tuam txhab kev tswj hwm zoo los ntawm kev tshuaj xyuas tus kheej hauv GMP thiab sab nraud GMP audit (cov neeg siv khoom tshawb xyuas, kev txheeb xyuas thib peb thiab cov chaw tswj xyuas kev tswj xyuas).