Mu gihe cyo gushushanya icyumba gisukuye cya GMP, inzira abantu n'ibikoresho bigomba gutandukanywa, ku buryo nubwo haba hari umwanda ku mubiri, utazakwirakwira mu gicuruzwa, kandi ni nako bimeze ku gicuruzwa.
Amahame yo kwitondera
1. Abakoresha ibikoresho n'ibikoresho byinjira ahantu hasukuye ntibashobora gusangira umuryango umwe. Imiyoboro y'ibikoresho n'ibikoresho byinjiramo igomba gutangwa ukwayo. Niba ibikoresho fatizo n'ibikoresho by'inyongera n'ibikoresho byo gupfunyika bihuye n'ibiribwa bipfunyitse neza, ntibizatera umwanda ku bindi, kandi inzira y'ibikorwa ikaba ikwiye, muri rusange, hashobora gukoreshwa umuryango umwe. Ku bikoresho n'imyanda ishobora kwanduza ibidukikije, nka karubone ikora n'ibisigazwa byakoreshejwe cyangwa byakozwe mu gihe cyo gukora, hagomba gushyirwaho inzira zihariye zo kwinjira n'aho gusohokera kugira ngo hirindwe kwanduza ibikoresho fatizo, ibikoresho by'inyongera cyangwa ibikoresho byo gupfunyika imbere. Ni byiza gushyiraho inzira zitandukanye zo kwinjira n'aho gusohokera ibikoresho byinjira ahantu hasukuye n'ibicuruzwa byarangiye byoherejwe ahantu hasukuye.
2. Abakoresha ibikoresho n'ibikoresho byinjira mu gace gasukuye bagomba gushyiraho ibyumba byabo byo gusukura cyangwa bagafata ingamba zo kubisukura. Urugero, abakoresha bashobora kwinjira mu gace gasukuye banyuze mu gifunga cy'umwuka nyuma yo kwiyuhagira, bambaye imyenda isuku y'akazi (harimo ingofero zo gukora, inkweto zo gukora, uturindantoki, udupfukamunwa, nibindi), kwiyuhagira mu mwuka, gukaraba intoki, no kwisukura intoki. Ibikoresho bishobora kwinjira mu gace gasukuye binyuze mu gifunga cy'umwuka cyangwa agasanduku k'impapuro nyuma yo gukuramo ipaki yo hanze, kwiyuhagira mu mwuka, gusukura ubuso, no kwisukura.
3. Kugira ngo hirindwe kwanduzwa kw'ibiribwa n'ibintu biturutse hanze, mu gihe cyo gushushanya imiterere y'ibikoresho bikoreshwa mu gutunganya, ibikoresho bifitanye isano n'umusaruro, ibikoresho n'ibyumba byo kubikamo ibikoresho bigomba gushyirwa mu gice gisukuye cy'umusaruro. Ibikoresho bya leta nk'ibyuma bikonjesha, silindiri, imashini zikoresha umwuka uvamo umwuka, ibikoresho byo gukuraho ivumbi, ibikoresho byo gukuraho ubushuhe, n'ibikoresho bisohora umwuka uvamo umwuka bigomba gushyirwa mu gice gisanzwe cy'umusaruro igihe cyose ibisabwa mu gutunganya ibintu bibisaba. Kugira ngo hirindwe kwanduzwa kw'ibiribwa, ibiryo bitandukanye n'ubwoko butandukanye ntibishobora gukorwa mu cyumba kimwe gisukuye icyarimwe. Kubera iyo mpamvu, ibikoresho bikoreshwa mu gutunganya ibintu bigomba gushyirwa mu cyumba gisukuye cyihariye.
4. Mu gihe ushushanya inzira inyura ahantu hasukuye, menya neza ko inzira inyuramo igera ahantu hose hakorerwa, mu bubiko bw'ibikoresho byo hagati cyangwa mu bubiko bw'ibikoresho bipfunyitse. Ibyumba byo gukoreramo cyangwa ibyumba byo kubikamo ibikoresho byo mu zindi nkingi ntibishobora gukoreshwa nk'inzira ibikoresho n'abakoresha binjiramo, kandi ibikoresho bimeze nk'ifuru ntibishobora gukoreshwa nk'inzira abakozi bakoresha. Ibi bishobora gukumira kwanduza ubwoko butandukanye bw'ibiribwa bitewe no gutwara ibikoresho no kugenda kw'abakoresha.
5. Bitagize ingaruka ku migendekere y'ibikorwa, imikorere y'ibikorwa, n'imiterere y'ibikoresho, niba ibipimo bya sisitemu yo gukonjesha mu byumba byo gukoreramo byegeranye ari bimwe, inzugi zishobora gufungurwa ku nkuta zo kugabanyamo ibice, udusanduku tw'inzira dushobora gufungurwa, cyangwa imikandara yo koherezamo ibikoresho ishobora gushyirwaho kugira ngo yohereze ibikoresho. Gerageza gukoresha inzira nke cyangwa ntayo ihuriweho hanze y'icyumba cyo gukoreramo gisukuye.
6. Niba ahantu ho gusya, gukinga, gupima, kuzuza, gukamisha API n'ahandi hantu hatanga ivumbi rinini bidashobora gupfundikirwa neza, hiyongereyeho ibikoresho bikenewe byo gufata ivumbi no gukuraho ivumbi, icyumba cyo gukoreramo imbere nacyo kigomba gutegurwa. Kugira ngo hirindwe kwanduza ibyumba byegeranye cyangwa inzira zihuriweho. Byongeye kandi, ku myanya ifite ubushyuhe bwinshi n'amazi asesagura, nko gutegura ibintu bikomeye no gutegura inshinge, uretse gushushanya igikoresho cyo gukuraho ubushuhe, icyumba cyo imbere gishobora kandi gutegurwa kugira ngo kitagira ingaruka ku mikorere y'icyumba gisukuye cyegeranye bitewe n'amazi menshi asesagura ubushuhe n'amazi asesagura ubushyuhe n'ibipimo by'umwuka ushyushye.
7. Ni byiza gutandukanya ascenseur zo gutwara ibikoresho na ascenseur mu nganda zifite ibyumba byinshi. Bishobora koroshya imiterere y'inzira y'abakozi n'iy'ibikoresho. Kubera ko ascenseur n'imirongo ari isoko ikomeye y'umwanda, kandi umwuka uri muri ascenseur n'imirongo biragoye gusukura. Kubwibyo, ntabwo bikwiye gushyira ascenseur ahantu hasukuye. Niba bitewe n'ibisabwa byihariye by'inzira cyangwa imbogamizi z'inyubako y'uruganda, ibikoresho byo gutunganya bigomba gutegurwa mu buryo butatu, kandi ibikoresho bigomba gutwarwa kuva hejuru kugera hasi cyangwa hasi kugera hejuru ahantu hasukuye hakoreshejwe ascenseur, hagomba gushyirwaho icyuma gifunga umwuka hagati ya ascenseur n'ahantu hasukuye ho gukorera. Cyangwa hagashyirwaho izindi ngamba zo kwemeza ko umwuka usukuye mu gace gakorerwamo.
8. Nyuma y'uko abantu binjiriye mu iduka banyuze mu cyumba cya mbere cyo guhinduranya ibikoresho n'icyumba cya kabiri cyo guhinduranya ibikoresho, n'ibintu byinjira mu iduka binyuze mu nzira y'ibikoresho n'inzira y'abakozi mu cyumba gisukuye cya GMP ntibitandukana. Ibikoresho byose bitunganywa n'abantu. Imirimo ntabwo igoye cyane iyo bigeze.
9. Inzira y'abakozi igomba kandi gutegurwa hashingiwe ku buso bwose n'ikoreshwa ry'ibicuruzwa. Ibyumba bimwe na bimwe byo kwimura imyenda by'abakozi b'ikigo, ibyumba byo kwimura imyenda, nibindi byagenewe metero kare nke gusa, kandi umwanya nyawo wo kwimura imyenda ni muto.
10. Ni ngombwa kwirinda neza aho abakozi bahurira, aho ibikoresho binyura, aho ibikoresho binyura, n'aho imyanda inyura. Ntibishoboka kwemeza ko ibintu byose bihuye neza mu buryo nyabwo bwo gushushanya. Hazabaho ubwoko bwinshi bw'amahugurwa yo gukora ibikoresho bya collinear, n'uburyo butandukanye bwo gukora ibikoresho.
11. Ni nako bimeze ku bijyanye n'ibikoresho. Hazabaho ingaruka zitandukanye. Uburyo bwo guhindura ibintu ntabwo busanzwe, uburyo bwo kubona ibikoresho ntabwo busanzwe, kandi zimwe zishobora kuba zifite inzira zo guhungiramo zakozwe nabi. Iyo habayeho ibiza nk'imitingito n'inkongi, iyo uri ahantu ho gufungira cyangwa ahantu hafi aho ugomba guhindura imyenda inshuro nyinshi, mu by'ukuri ni akaga cyane kuko ahantu hakozwe na GMP clean room ni hato kandi nta dirishya ryihariye ryo guhungiramo cyangwa igice gishobora kuvunika.
Igihe cyo kohereza ubutumwa: 26 Nzeri 2023