Uburyo bwiza bwo gukora cyangwa GMP ni uburyo bugizwe n'inzira, amabwiriza n'inyandiko zigaragaza ko ibicuruzwa bikorerwa mu nganda, nk'ibiribwa, amavuta yo kwisiga, n'ibicuruzwa by'imiti, bihora bikorwa kandi bigacungwa hakurikijwe amahame y'ubuziranenge. Gushyira mu bikorwa GMP bishobora gufasha kugabanya igihombo n'imyanda, kwirinda kwimurirwa mu rugo, gufatirwa, amande n'igifungo. Muri rusange, birinda ikigo n'abaguzi ingaruka mbi ku mutekano w'ibiribwa.
GMPs zisuzuma kandi zigakurikirana buri gice cy’imikorere kugira ngo hirindwe ingaruka zishobora guteza akaga ku bicuruzwa, nko kwanduzwa, guhindurwa, no gushyirwaho ibirango bitari byo. Hari ahantu hashobora kugira ingaruka ku mutekano n’ubwiza bw’ibicuruzwa amabwiriza n’amabwiriza ya GMP avugaho ni ibi bikurikira:
·Imicungire myiza
·Isuku n'isukura
·Inyubako n'ibikoresho
·Ibikoresho
·Ibikoresho fatizo
· Abakozi
· Kwemeza no kwemeza impamyabushobozi
·Ibirego
· Kwandika no kubika inyandiko
·Igenzura n'igenzura ry'ubuziranenge
Ni irihe tandukaniro riri hagati ya GMP na cGMP?
Uburyo bwiza bwo gukora (GMP) n'uburyo bwiza bwo gukora (cGMP) buriho ubu, akenshi birahindagurika. GMP ni itegeko ry'ibanze ryashyizweho n'Ikigo gishinzwe ibiribwa n'imiti muri Amerika (FDA) hakurikijwe ububasha bw'Itegeko rya Leta Zunze Ubumwe za Amerika rigenga ibiribwa, imiti n'ubwiza kugira ngo abakora bafate ingamba zo kwemeza ko ibicuruzwa byabo bifite umutekano kandi bifite akamaro. Ku rundi ruhande, cGMP yashyizwe mu bikorwa na FDA kugira ngo ikomeze kunoza uburyo abakora bagenzura ireme ry'ibicuruzwa. Bisobanura ko bagomba gukomeza kwiyemeza ku mahame meza aboneka binyuze mu gukoresha sisitemu n'ikoranabuhanga bigezweho.
Ni ibihe bice 5 by'ingenzi bigize imikorere myiza yo gukora?
Ni ngombwa cyane ko inganda zikora zigenzura GMP mu kazi kugira ngo zirebe ko ibicuruzwa bifite ubuziranenge n'umutekano bihoraho. Kwibanda kuri P 5 zikurikira za GMP bifasha kubahiriza amahame agenga mu gihe cyose cyo gukora.
Ama-P 5 ya GMP
1. Abantu
Abakozi bose basabwa gukurikiza amabwiriza n'amabwiriza agenga inganda. Abakozi bose bagomba guhugurwa muri iki gihe kugira ngo basobanukirwe neza inshingano zabo n'inshingano zabo. Gusuzuma imikorere yabo bifasha kongera umusaruro wabo, imikorere yabo n'ubushobozi bwabo.
2. Ibicuruzwa
Ibicuruzwa byose bigomba gupimwa buri gihe, kugereranya, no kugenzura ubuziranenge mbere yo kubikwirakwiza ku baguzi. Abakora bagomba kugenzura ko ibikoresho by'ibanze birimo ibikomoka ku bimera n'ibindi bigize ibi bicuruzwa bifite ibisobanuro bisobanutse neza muri buri cyiciro cy'umusaruro. Uburyo busanzwe bugomba kubahirizwa mu gupakira, gupima no gutanga ibicuruzwa by'icyitegererezo.
3. Inzira
Inzira zigomba kwandikwa neza, zisobanutse, zihamye, kandi zigakwirakwizwa ku bakozi bose. Hagomba gukorwa isuzumabumenyi rihoraho kugira ngo abakozi bose bubahiriza inzira zigezweho kandi bujuje ibisabwa n'ikigo.
4. Inzira zo gukora
Uburyo ni umurongo ngenderwaho wo gukora inzira y'ingenzi cyangwa igice cy'inzira kugira ngo haboneke umusaruro uhoraho. Igomba kumenyeshwa abakozi bose kandi igakurikizwa buri gihe. Gutandukira inzira isanzwe bigomba guhita bitangazwa kandi bigasuzumwa.
5. Ahantu hakorerwa imirimo
Ahantu hagomba gukorerwa isuku igihe cyose kugira ngo hirindwe kwanduzwa, impanuka, cyangwa ndetse n'urupfu. Ibikoresho byose bigomba gushyirwa cyangwa kubikwa neza kandi bigashyirwa mu byiciro buri gihe kugira ngo bibe bikwiye kugira ngo bitange umusaruro uhoraho kugira ngo hirindwe ibyago byo kwangirika kw'ibikoresho.
Amahame 10 ya GMP ni ayahe?
1. Gushyiraho Uburyo Busanzwe bwo Gukora (SOPs)
2. Gushyira mu bikorwa/gushyira mu bikorwa amabwiriza y'akazi n'amabwiriza y'akazi
3. Inyandiko z'amabwiriza n'inzira
4. Kugenzura imikorere ya SOPs
5. Gushushanya no gukoresha sisitemu z'imikorere
6. Kubungabunga sisitemu, ibikoresho, n'ibikoresho
7. Guteza imbere ubushobozi bw'abakozi mu kazi
8. Kurinda kwanduzanya binyuze mu isuku
9. Shyira imbere ubuziranenge no kubushyira mu bikorwa
10. Gukora igenzura rya GMP buri gihe
Uburyo bwo kubahiriza GIbipimo ngenderwaho bya MP
Amabwiriza n'amabwiriza ya GMP avuga ku bibazo bitandukanye bishobora kugira ingaruka ku mutekano n'ubwiza bw'ibicuruzwa. Kuba byujuje amahame ya GMP cyangwa cGMP bifasha ikigo kubahiriza amabwiriza y'amategeko, kongera ubwiza bw'ibicuruzwa byacyo, kunoza kunyurwa kw'abakiriya, kongera kugurisha, no kubona inyungu mu ishoramari.
Gukora igenzura rya GMP bigira uruhare runini mu gusuzuma niba ikigo cyubahiriza amabwiriza n'amabwiriza agenga inganda. Gukora igenzura rihoraho bishobora kugabanya ibyago byo kwangirika no kurenga ku izina. Igenzura rya GMP rifasha kunoza imikorere rusange ya sisitemu zitandukanye harimo izi zikurikira:
·Inyubako n'ibikoresho
·Imicungire y'ibikoresho
·Sisitemu zo kugenzura ubuziranenge
·Gukora
·Gupakira no kwandika ibirango by'indangamuntu
·Sisitemu zo gucunga neza
·Amahugurwa ku bakozi n'abashinzwe ikoranabuhanga rya GMP
·Kugura
·Serivise ku bakiriya
Igihe cyo kohereza: Werurwe-29-2023