Itandukaniro hagati ya CGMP y'Abanyamerika na GMP ya kera y'Ubushinwa (Igice cya II)

Urwego Rurambuye

Muri Amerika, amahame ya GMP yavuzwe mu gice cya 210 no mu gice cya 211 cy'amategeko ngengamikorere.Kubera ko aya mabwiriza bigoye guhindura cyangwa kongeramo, FDA yasohoye inyandiko zitandukanye zamabwiriza ya GMP nubuyobozi bukora kumiti, nkaUbuyobozi bw'inganda.Izi dosiye zihora zihindurwa kandi zongeweho zitwa amabwiriza ya CGMP.Amwe murayo mabwiriza ajyanye nubushakashatsi bushya bwibiyobyabwenge no kwiyandikisha, nka ICH (Q1-Q10).Uburyo bwo gukora uburyo bwo kwemeza, kwemeza inzira nibindi bijyanye na GMP nabyo byashyizwe muri izi nyandiko, arizo ngenderwaho zubahirizwa muri GMP ku igenzura.Mubyongeyeho, amabwiriza amwe arekurwa kubagenzuzi ba GMP nkibisobanuro, nkaAmabwiriza yo Kugenzura Ifishi Yimiti Abakora ibiyobyabwenge, Imfashanyigisho yo kugenzura sisitemu nziza, Kwemeza inzira zogusukuran'ibindi Ntabwo ari itegeko gukoresha aya mabwiriza.Kuberako abagenzuzi ba FDA aribo bonyine bemerewe guhitamo niba imikorere yimikorere yuwayikoze yujuje ubuziranenge "bugezweho", abakora ibiyobyabwenge bagomba gukurikiza cGMP nandi mabwiriza agezweho kandi bakisuzuma ubwabo kugirango barebe niba ibipimo byakozwe.Bitabaye ibyo, byafatwa nk '"bitemewe" bagahanwa.

 Igishinwa GMP (1998 cyasohotse) kiroroshye cyane kandi kidasobanutse, kidafite ubuyobozi bwihariye nibisabwa ukurikije amahame ya GMP.Ku mugereka wa GMP yo mu 1998, ubwoko butandatu bwibiyobyabwenge bwazanwe nubuyobozi bugufi.Kugeza ubu, haracyari ubusa muri GMP itanga umurongo ngenderwaho.Impamyabushobozi y'ibikoresho no kwemeza, kwemeza inzira, kwemeza uburyo, kwemeza sterilisation hamwe n'ubundi buryo bwihariye bwo gukora bwakozwe nta bipimo birambuye, bitera ubuyobozi busubira inyuma.

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