GMP vs GLP
GMP thiab GLP yog cov kev cai uas tau tsim los ntawm FDA rau cov khw muag khoom kho mob. Thaum GMP siv rau cov khoom lag luam uas tsim los rau tib neeg siv, GLP yog cov txheej txheem kev npaj rau kev saib xyuas kev ncaj ncees thiab zoo ntawm cov ntaub ntawv lab uas yog siv los ntawm cov tuam txhab tsim khoom los tiv thaiv cov lus thov uas lawv tsim txog lawv cov khoom. Thaum lub hom phiaj tseem ceeb ntawm ob qho tib si GMP thiab GLP yog los tiv thaiv kev noj qab haus huv ntawm cov neeg siv khoom kawg, ob qho tib si sib txawv thiab siv rau cov tshuab sib txawv.
Lub tswv yim ntawm GMP, uas sawv cev rau Kev Tsim Khoom Zoo, thiab GLP, uas sawv cev rau Kev Ntsuas Zoo, yog lub hlwb ntawm FDA uas tau teeb meem los ntawm kev tsis txaus siab nws tau txais tsis tu ncua txog cov tshuaj zoo thiab lwm yam khoom kho mob.. Nws tau thov qee cov lus qhia uas txhua lub tuam txhab lees txais GMP thiab GLP yuav tsum ua raws, kom tau txais ntawv pov thawj los ntawm FDA. GMP yog laus dua ntawm ob qho raws li nws tau los ua nyob rau hauv 1963 thaum GLP tau npaj rau xyoo 1976 thiab tuaj rau hauv xyoo 1978. Ua ke, ob qho tib si GMP thiab GLP kom ntseeg tau cov khoom zoo nrog rau lawv cov txheej txheem kuaj.
Hnub no, GMP thiab GLP tau dhau los ua qhov kev lees paub ntawm qhov zoo. Ib lub tuam txhab uas muaj cov ntawv pov thawj no ua rau muaj kev ntseeg siab ntawm cov neeg siv khoom tias nws cov khoom tswj hwm cov txheej txheem siab zoo thiab tseem tias tag nrho cov txheej txheem raug tau ua raws hauv lawv cov khoom.
Thaum GLP tsom mus rau kev kuaj sim, cov txheej txheem, cov cuab yeej siv, cov ntaub ntawv thiab cov ntaub ntawv khaws cia, cov chaw sim thiab kev tswj xyuas qhov zoo, GMP muaj kev txhawj xeeb ntau dua nrog kev tsim khoom thiab cov khoom kho mob raws li nws hais txog qhov chaw uas cov khoom raug tsim, tsim nyog ntawm cov neeg ua haujlwm, cog thiab tshuab, thiab cov txheej txheem ntim khoom siv.
Feem ntau, GLP raug suav tias yog tus nqi qis dua thiab nyuaj dua GMP. Txawm li cas los xij, cov tuam txhab tsim khoom siv zog kom tau txais ob daim ntawv pov thawj raws li lawv yog cov pov thawj ntawm qhov zoo thiab kev ncaj ncees ntawm lub tuam txhab. Txhua lub tuam txhab xav kom tau txais cov ntawv pov thawj no yuav tsum tau txais cov neeg ua haujlwm cob qhia raws li kev cai ntawm FDA.
In luv:
GMP vs GLP
• GMP thiab GLP yog cov cai tswj hwm los ntawm FDA rau cov tuam txhab cov khoom kho mob kom ntseeg tau cov khoom zoo thiab kev ncaj ncees
• Thaum GMP cuam tshuam rau cov khoom lag luam uas tsim los rau tib neeg siv, GLP yog hais txog kev kuaj sim
• GMP tau qhia ua ntej GLP
• GLP tsawg tus nqi thiab cumbersome dua GMP
• GMP cov kev cai cuam tshuam rau cov neeg ua haujlwm, cog thiab tshuab thiab kev tsim khoom thiab ntim cov txheej txheem thaum GLP cuam tshuam rau kev kuaj sim, kev khaws cov ntaub ntawv thiab cov ntaub ntawv, thiab kev tswj xyuas zoo thaum kuaj.
