Imyitozo myiza cyangwa GMP ni sisitemu igizwe nibikorwa, inzira ninyandiko zemeza ibicuruzwa, nkibiryo, kwisiga, hamwe nibicuruzwa byimiti, bigengwa hakurikijwe ibipimo ngenderwaho. Gushyira mu bikorwa GMP birashobora gufasha guca igihombo n'imyanda, irinde kwibuka, gufata, amande n'ibicurane. Muri rusange, irinda isosiyete ndetse ninzi ko umuguzi mubintu bibi byibiribwa.
GMPS isuzuma kandi ikubiyemo ibintu byose bigize gahunda yo gukora irinda ingaruka zose zishobora kuba zizabicuruzwa, nko kwanduza, kugirira ubusambanyi, no kuvuga nabi. Ahantu tumwe gashobora guhindura umutekano nubwiza bwibicuruzwa ko admini ourganine na aderesi yamategeko ni izi zikurikira:
Ubuyobozi bwiza
· Isuku n'isuku
· Inyubako n'ibikoresho
· Ibikoresho
Ibikoresho bya Raw
· Abantu
· Kwemeza no gutangara
· Ibibazo
· Inyandiko no kubika inyandiko
· Ubugenzuzi & Ubugenzuzi Bwiza
Ni irihe tandukaniro riri hagati ya GMP na CGMP?
Imikorere myiza yo gukora (GMP) hamwe nuburyo bwiza bwo gukora (cgmp), mubihe byinshi, guhinduka. GMP ni amabwiriza y'ibanze asabwa n'ibiryo by'Amerika n'ibiyobyabwenge (FDA) mu biyobyabwenge, ibiyobyabwenge, no kwisiga kugira ngo abakora bafate ingamba zifatika zo kwemeza ibicuruzwa byabo kandi bigira akamaro. Ku rundi ruhande, CGMP, yashyizwe mu bikorwa na FDA kugirango iterambere rihoraho mu buryo bwo gukora ku bwiza bw'ibicuruzwa. Bisobanura guhora twiyemeje ibipimo byiza byinshi biboneka binyuze muburyo bugezweho na sisitemu nikoranabuhanga.
Nibihe 5 by'ingenzi bigize imyitozo myiza yo gukora?
Nibyinshi mubikorwa byo gukora kugirango ugenzure GMP kumurimo kugirango umenye neza ubuziranenge n'umutekano wibicuruzwa. Kwibanda kuri GMP 5 ikurikira ifasha kubahiriza amahame akomeye mumikorere yose.
5 p ya gmp
1. Abantu
Abakozi bose bategerejweho gukurikiza neza ibikorwa n'amabwiriza. Amahugurwa ya GMP yiki gihe agomba gukorwa nabakozi bose kugirango bumve neza inshingano zabo ninshingano zabo. Gusuzuma imikorere yabo bifasha kuzamura umusaruro wabo, gukora neza, nubushobozi.
2. Ibicuruzwa
Ibicuruzwa byose bigomba guhora bipimisha, ugereranije, nubwishingizi bwiza mbere yo gukwirakwiza abaguzi. Abakora bagomba kwemeza ko ibikoresho byingenzi birimo ibicuruzwa bibisi nibindi bigize bifite ibisobanuro bisobanutse kuri buri cyiciro cyumusaruro. Uburyo busanzwe bugomba kubahirizwa mugupakira, kwipimisha, no gutanga ibicuruzwa byicyitegererezo.
3. Inzira
Inzira zigomba kuba zanditse neza, zisobanutse, zihamye, kandi zigaburira abakozi bose. Isuzuma risanzwe rigomba gukorwa kugirango abakozi bose bakurikiza inzira zubu kandi bahurira ibipimo bisabwa byumuryango.
4. Inzira
Inzira ni urutonde rw'amabwiriza yo gukora inzira cyangwa igice cyinzira kugirango tugere ku bisubizo bihamye. Igomba gushyirwa kubakozi bose igakurikiraho. Gutandukana kwayo ku buryo busanzwe bugomba kumenyeshwa ako kanya kandi bigakora iperereza.
5. Ibibanza
Ibibanza bigomba guteza imbere isuku igihe cyose kugirango wirinde kwanduza, impanuka, ndetse no gupfa. Ibikoresho byose bigomba gushyirwaho cyangwa kubikwa neza kandi bikaba byahinduwe buri gihe kugirango bibe neza ko bigamije gutanga ibisubizo bihamye kugirango birinde ibyago byo kunanirwa kw'ibikoresho.
Ni ayahe mahame 10 ya GMP?
1. Kora uburyo busanzwe bwo gukora (SOP)
2. Gushyira mubikorwa / gushyira mubikorwa sops namabwiriza y'akazi
3. Uburyo bw'inyandiko n'imikorere
4. Kwemeza imikorere ya sops
5. Gushushanya no gukoresha sisitemu ikora
6. Komeza sisitemu, ibikoresho, nibikoresho
7. Gutezimbere ubushobozi bwakazi
8. Irinde kwanduza binyuze mu isuku
9. Shyira imbere ubuziranenge no kwinjiza mukazi
10.CMnda GMP igenzura buri gihe
Uburyo bwo kubahiriza G.Depite
Amabwiriza na GMP namabwiriza akemura ibibazo bitandukanye bishobora guhindura umutekano nubwiza bwibicuruzwa. Guhura na GMP cyangwa ibipimo bya CGMP bifasha umuryango kubahiriza amategeko, kongera ubwiza bwibicuruzwa byabo, komeza kunyurwa nabakiriya, ongeraho kunyurwa kwabakiriya, byongera kugurisha, kandi ubone inyungu zishoramari.
Kuyobora GMP bigira uruhare runini mugusuzuma kubahiriza umuryango kugirango ukoreshe protocole namabwiriza. Gukora cheque isanzwe birashobora kugabanya ibyago byo gusambana no kuvuza nabi. Ubugenzuzi bwa GMP bufasha kunoza imikorere rusange ya sisitemu zitandukanye harimo n'ibi bikurikira:
· Inyubako n'ibikoresho
Ubuyobozi bwibikoresho
Uburyo bwo kugenzura neza · kugenzura ubuziranenge
· Gukora
· Gupakira no Kumenyekanisha Ikirango
· Sisitemu yo gucunga ubuziranenge
· Abantuteri na GMP
· Kugura
· Serivisi zabakiriya
Igihe cya nyuma: Werurwe-29-2023