GMP (Imyitozo myiza yo gukora) ni umurongo ngenderwaho ugamije kugenzura no kugenzura ibikorwa byo gukora imiti kwisi yose.Ni uruhushya rukenewe kubakora imiti yinjira mubucuruzi mpuzamahanga.
GMP ikubiyemo: ibikoresho, abantu, urubuga, isuku, kwemeza, inyandiko, umusaruro, ubuziranenge, kugurisha, kongera gukoresha no kugenzura nibindi. indi miti, gutandukana no gutandukana kuvanga ibice bitandukanye, impanuka zo kubura intambwe zo kugenzura, imikorere idahwitse nibindi bikorwa bidakwiye.
Igitekerezo cya GMP cyazanywe mu myaka ya za 80 y'Ubushinwa kandi gitangazwa ku mugaragaro ko ari amabwiriza yuzuye kandi ateganijwe ku ya 1 Nyakangast, 1999. Muri Amerika, cGMP (ngufi kubikorwa byiza byo gukora muri iki gihe) yasohotse muri CFR igice cya 210 naho igice cya 211 muri 90.
Muri rusange, intego, ihame, ingingo nibisabwa bya GMP yo mu Bushinwa birasa nkibya cGMP y'Abanyamerika ariko mubyukuri hariho itandukaniro ryinshi nkibi bikurikira.
Inzira yo Kwemererwa
Icyemezo cya GMP y'Ubushinwa nicyemezo gusa cyo gukora uruhushya rwo gukora imiti, usibye kwandikisha ibicuruzwa.Nyuma yuwabikoze yemerewe ibicuruzwa bishya bifite numero yo kwiyandikisha, irashobora gukomeza gusaba ibyemezo bya GMP.Byongeye kandi, amakuru yibice bitatu byumusaruro hamwe namakuru yo gusuzuma ituze byibuze mumezi atandatu arasabwa kohereza ibicuruzwa cyangwa icyemezo cya GMP.
Icyemezo cya cGMP y'Abanyamerika kigizwe n'ibice bibiri: Gutezimbere ibicuruzwa no kugenzura imiti.Ibyo bivuze ko kwandikisha umusaruro no gukora uruhushya bigenda icyarimwe.Hariho ubwoko bubiri bwo kwandikisha ibicuruzwa muri Amerika: Gusaba Ibiyobyabwenge bishya (NDA) hamwe na Appbreviated New Drug Application (ANDA).NDA isaba amakuru yibice bitatu byumusaruro namakuru yo gusuzuma ituze mumezi atandatu.ANDA isaba amakuru yicyiciro cyumusaruro namakuru yo gusuzuma ituze mumezi atatu.Amakuru yo gukomeza gusuzuma no kwemeza azabikwa nuwabikoze kandi atangazwa muri raporo yumwaka kuri FDA.
Ohereza ubutumwa bwawe:
Igihe cyo kohereza: Ukwakira-27-2017