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Impamyabumenyi
Ibisabwa: Menya ibya ngombwa.
Ijambo impamyabumenyi imaze kugira ibisobanuro byasobanuwe mwizina ryayo: Kurinda no kwemeza ireme ryibikorwa. Muri GMP yujuje ibya farumasi n’ibiribwa, ibyangombwa cyangwa ibikoresho ni ngombwa. Turagushyigikiye mugukora ibizamini byose bikenewe byibikoresho bya radobio kimwe ninyandiko.
Hamwe nubushobozi bwibikoresho, werekana ko igikoresho cyawe cyashyizweho (IQ) kandi gikora neza (OQ) ukurikije amabwiriza ya GMP. Ikintu kidasanzwe ni Impamyabushobozi (PQ). Iyi mpamyabushobozi yimikorere ni igice cyo kwemeza ibikorwa byose byakozwe mugihe runaka no kubicuruzwa runaka. Ibihe byihariye byabakiriya nibikorwa birasuzumwa kandi byanditse.
Urashobora gusoma serivise kugiti cya radobio itanga nkigice cya IQ / OQ / PQ muburyo burambuye mugice cyikoranabuhanga.
Ni ukubera iki impamyabumenyi ya radobio yawe ari ngombwa?
Ubwiza buhoraho bwibicuruzwa dukora - tutibagiwe no kubyara uburyo bwo gukora ibizamini - ni ingenzi kuri laboratoire n'ibikoresho bikora bikurikiza ibisabwa na GMP cyangwa GLP. Inshingano yavuyemo yo gutanga ibimenyetso bifatika isaba umubare munini wibizamini bigomba gukorwa kandi bikandikwa neza. RADOBIO irashobora kugufasha kugabanya cyane akazi kajyanye no kuzuza no kwemeza ibice.
IQ, OQ na PQ bisobanura iki?
IQ - Impamyabumenyi yo kwishyiriraho
IQ, isobanura ibyangombwa byo kwishyiriraho, yemeza ko igice cyashyizweho neza ukurikije ibyo abakiriya bakeneye harimo ibyangombwa. Umutekinisiye agenzura ko igice cyashyizweho neza, nkuko bigaragara mububiko bwujuje ibyangombwa. Impapuro zujuje ibyangombwa zishobora gutumizwa kumurongo wihariye.
OQ - Impamyabumenyi ikora
OQ, cyangwa Impamyabushobozi ikora, igenzura kandi ikemeza ko igice gikora neza muburyo butapakuruwe. Ibizamini bisabwa birahari mububiko bwubushobozi.
PQ - Impamyabumenyi
PQ, igereranya ibyangombwa bisabwa, igenzura ninyandiko imikorere yikintu muri leta iremerewe mubisabwa byihariye byabakiriya. Ibizamini bisabwa bisobanurwa nubwumvikane ukurikije ibisobanuro byabakiriya.
Ni izihe nyungu uzabona muri kalibrasi?
RADOBIO irashobora kugufasha kugabanya cyane akazi kajyanye no kuzuza no kwemeza ibice.
Amakuru yororoka
Ibisobanuro byororoka kubice bya radobio - bihuye nibikorwa byawe nibipimo
Ubuhanga bwa RADOBIO
Gukoresha ubuhanga bwa RADOBIO mugihe cyo kwemeza no kuzuza ibisabwa
inzobere zibishoboye kandi zifite uburambe
Gushyira mubikorwa ninzobere zibishoboye kandi zifite uburambe
Twishimiye kugutera inkunga hamwe nubushobozi bwawe bwa IQ / OQ no mugushiraho gahunda yikizamini kuri PQ yawe.
Twandikire gusa.