Icyemezo cya GMP na Sisitemu yo gucunga GMP

GMP ni iki?

GMP-Imyitozo myiza yo gukora

Irashobora kandi kwitwa imyitozo ngororamubiri nziza (cGMP).

Ibikorwa byiza byo gukora byerekeza ku mategeko n'amabwiriza yerekeye umusaruro no gucunga neza ibiribwa, ibiyobyabwenge n’ibicuruzwa by’ubuvuzi.Bisaba inganda kuzuza ibisabwa by’ubuziranenge bw’isuku mu bijyanye n’ibikoresho fatizo, abakozi, ibikoresho n’ibikoresho, uburyo bwo kubyaza umusaruro, gupakira no gutwara abantu , kugenzura ubuziranenge, nibindi hakurikijwe amategeko n'amabwiriza bijyanye n’igihugu, gushyiraho urutonde rwibikorwa bikora bifasha ibigo guteza imbere isuku y’ibigo, no kubona ibibazo mubikorwa by’umusaruro mugihe cyo kunoza.

Itandukaniro riri hagati y’Ubushinwa n’ibindi bihugu byinshi ku isi ni uko ikoreshwa ry’ibiyobyabwenge n’abantu bakoresha imiti y’amatungo bitandukanye mu Bushinwa, ryemera gukoresha ibiyobyabwenge by’abantu GMP n’ibiyobyabwenge by’amatungo GMP. Kuva aho hashyizwe mu bikorwa icyemezo cy’ibiyobyabwenge GMP mu Bushinwa, cyaravuguruwe muri 2010 kandi ashyira mubikorwa kumugaragaro verisiyo nshya ya GMP muri 2011. verisiyo nshya yicyemezo cya GMP itanga ibisabwa cyane kugirango habeho imyiteguro idasanzwe na APIs.

None se kuki inganda nyinshi zimiti zikeneye gutsinda icyemezo cya GMP?

Abakora inganda cyangwa ibigo bifite ibyemezo bya GMP bahabwa ubugenzuzi bukomeye n’inzego z’igihugu zibishinzwe mu buryo butandukanye nko gukora ibicuruzwa no gupima. Ku baguzi, ni inzitizi yo kugenzura ubuziranenge bw’ibicuruzwa, kandi ni n'uburinzi ku bigo ubwabyo, ku buryo ibyabo ibicuruzwa bifite urwego rwo kugenzura neza ubuziranenge bwibicuruzwa.

Ibigo bifite icyemezo cya GMP bigomba gushyiraho uburyo bwo gucunga neza ubuziranenge bwa GMP kugirango harebwe ubusugire n’ikurikiranwa ry’ubuziranenge bw’ikigo, kubera ko uruganda kandi rwakira buri gihe igenzura rya GMP mu kigo cy’igihugu gishinzwe ibiribwa n’ibiyobyabwenge buri myaka itanu kugira ngo risuzume inyandiko zose za GMP n’ibikorwa bijyanye amateka yamateka yikigo mumyaka itanu ishize.

Nkuruganda rwa GMP,Handeishyira mu bikorwa imicungire y’ubuziranenge hubahirijwe cyane ibisabwa na cGMP hamwe n’inyandiko zicunga ubuziranenge muri iki gihe. Ishami rishinzwe ubuziranenge rigenzura ishyirwa mu bikorwa ry’imirimo myiza mu mashami yose, kandi rikomeza kunoza no kunoza imikorere y’imicungire y’isosiyete binyuze mu igenzura ry’imbere rya GMP no hanze ya GMP. ubugenzuzi (ubugenzuzi bwabakiriya, ubugenzuzi bwabandi-ubugenzuzi bwikigo).