Ibikorwa byiza byo gukora cyangwa GMP ni sisitemu igizwe nuburyo, inzira hamwe ninyandiko zituma ibicuruzwa bikora, nkibiryo, amavuta yo kwisiga, n’ibicuruzwa bikoreshwa mu bya farumasi, bihora bikorerwa kandi bikagenzurwa hakurikijwe ibipimo ngenderwaho byashyizweho. Gushyira mu bikorwa GMP birashobora kugabanya kugabanya igihombo n’imyanda, kwirinda kwibuka, gufatira, ihazabu nigihe cyo gufungwa. Muri rusange, irinda isosiyete n’abaguzi kwirinda ingaruka mbi z’umutekano w’ibiribwa.
GMPs isuzuma kandi ikubiyemo ibintu byose bigize inzira yo gukora kugirango birinde ingaruka zose zishobora guteza ingaruka ku bicuruzwa, nko kwanduzanya, gusambana, no kutibeshya. Ibice bimwe bishobora guhungabanya umutekano nubuziranenge bwibicuruzwa umurongo ngenderwaho wa GMP hamwe n’amabwiriza ni ibi bikurikira:
Gucunga ubuziranenge
· Isuku n’isuku
· Inyubako n'ibikoresho
· Ibikoresho
· Ibikoresho bito
· Abakozi
· Kwemeza no kuzuza ibisabwa
· Ibirego
· Inyandiko no kubika inyandiko
Kugenzura & ubugenzuzi bufite ireme
Ni irihe tandukaniro riri hagati ya GMP na cGMP?
Ibikorwa byiza byo gukora (GMP) hamwe nuburyo bwiza bwo gukora (cGMP), mubihe byinshi, birashobora guhinduka. GMP ni amabwiriza shingiro yatangajwe n’ikigo cy’Amerika gishinzwe ibiribwa n’ibiyobyabwenge (FDA) kiyobowe n’amategeko agenga ibiribwa, ibiyobyabwenge, n’amavuta yo kwisiga kugira ngo ababikora bafate ingamba zifatika zo kwemeza ko ibicuruzwa byabo bifite umutekano kandi neza. Ku rundi ruhande, cGMP, yashyizwe mu bikorwa na FDA kugira ngo habeho iterambere rihoraho mu buryo bw'abakora ibicuruzwa byiza. Bisobanura guhora twiyemeje kurwego rwo hejuru rushobora kuboneka hifashishijwe sisitemu na tekinoroji igezweho.
Nibihe bintu 5 byingenzi bigize imyitozo myiza yo gukora?
Nibyingenzi mubikorwa byinganda kugenzura GMP kumurimo kugirango habeho ubuziranenge numutekano byibicuruzwa. Kwibanda kuri 5 P ikurikira ya GMP bifasha kubahiriza amahame akomeye mubikorwa byose byakozwe.
5 P ya GMP
1. Abantu
Abakozi bose bategerejweho gukurikiza byimazeyo inzira n’amabwiriza. Amahugurwa ya GMP agezweho agomba gukorwa nabakozi bose kugirango basobanukirwe neza inshingano zabo ninshingano zabo. Gusuzuma imikorere yabo bifasha kuzamura umusaruro wabo, gukora neza, nubushobozi bwabo.
2. Ibicuruzwa
Ibicuruzwa byose bigomba kwipimisha buri gihe, kugereranya, hamwe nubwishingizi bwiza mbere yo kugabura abaguzi. Ababikora bagomba kwemeza ko ibikoresho byibanze birimo ibicuruzwa bibisi nibindi bikoresho bifite ibisobanuro bisobanutse kuri buri cyiciro cyumusaruro. Uburyo busanzwe bugomba kubahirizwa mugupakira, kugerageza, no gutanga ibicuruzwa byintangarugero.
3. Inzira
Inzira zigomba kuba zanditse neza, zisobanutse, zihamye, kandi zigabanywa abakozi bose. Isuzuma rihoraho rigomba gukorwa kugirango abakozi bose bubahirize inzira zigezweho kandi zujuje ubuziranenge bwumuryango.
4. Inzira
Inzira ni umurongo ngenderwaho wo gukora inzira ikomeye cyangwa igice cyibikorwa kugirango ugere kubisubizo bihamye. Igomba gushyirwa ku bakozi bose kandi igakurikizwa buri gihe. Gutandukana muburyo busanzwe bigomba kumenyeshwa ako kanya bigakorwaho iperereza.
5. Ibibanza
Ibibanza bigomba guteza imbere isuku igihe cyose kugirango birinde kwanduzanya, impanuka, cyangwa n’impfu. Ibikoresho byose bigomba gushyirwa cyangwa kubikwa neza kandi bigahinduka buri gihe kugirango byemeze ko bihuye hagamijwe gutanga ibisubizo bihamye kugirango birinde ingaruka ziterwa n’ibikoresho.
Ni ayahe mahame 10 ya GMP?
1. Shiraho uburyo bukoreshwa muburyo bukoreshwa (SOP)
2. Shimangira / Shyira mu bikorwa SOP n'amabwiriza y'akazi
3. Inzira ninyandiko
4. Kwemeza imikorere ya SOP
5. Shushanya kandi ukoreshe sisitemu y'akazi
6. Komeza sisitemu, ibikoresho, nibikoresho
7. Gutezimbere ubushobozi bwakazi bwabakozi
8. Irinde kwanduza binyuze mu isuku
9. Shyira imbere ubuziranenge no kwinjiza mubikorwa
10.Kora igenzura rya GMP buri gihe
Uburyo bwo kubahiriza G.Umudepite
Amabwiriza ya GMP akemura ibibazo bitandukanye bishobora guhungabanya umutekano nubwiza bwibicuruzwa. Kuzuza ibipimo bya GMP cyangwa cGMP bifasha ishyirahamwe kubahiriza amategeko ashyiraho amategeko, kongera ubwiza bwibicuruzwa byabo, kuzamura abakiriya, kongera ibicuruzwa, no kubona inyungu zishoramari.
Gukora igenzura rya GMP bigira uruhare runini mugusuzuma iyubahirizwa ryumuryango kubahiriza protocole nubuyobozi. Gukora igenzura risanzwe birashobora kugabanya ingaruka zo gusambana no gufata nabi. Igenzura rya GMP rifasha kunoza imikorere rusange ya sisitemu zitandukanye harimo n'ibi bikurikira:
· Inyubako n'ibikoresho
Gucunga ibikoresho
Sisitemu yo kugenzura ubuziranenge
Gukora
· Gupakira no kuranga ibiranga
Sisitemu yo gucunga neza
· Amahugurwa y'abakozi na GMP
Kugura
Serivise y'abakiriya
Igihe cyo kohereza: Werurwe-29-2023