Vuba aha, uruganda rukora imiti rwakorewe iperereza kandi rukemurwa n’inzego zibishinzwe kubera ingaruka zishobora guhungabanya umutekano muri gahunda y’imicungire y’ubuziranenge maze rusaba uruganda rukora imiti guhita ruhagarika umusaruro kugira ngo rukosorwe, kandi icyemezo cy’umwimerere cy’ibiyobyabwenge “GMP” nacyo cyavanyweho.

Ku bw'amahirwe, muri Nzeri 2020, FDA (Ikigo gishinzwe ibiryo n'ibiyobyabwenge muri Amerika) yasohoye ibaruwa yo kuburira isosiyete ikora imiti igabanya ubukana bwa antibacterial mu Buhinde. Iyi baruwa yihanangirije cyane ko iyi sosiyete itashyize mu bikorwa ingamba zisanzwe zo kugenzura isuku mu gihe ikora ibiyobyabwenge biheruka, ariko yibanze ku kurandura burundu bagiteri, byatera ibyago byo kwanduza izindi ngaruka zogusukura no kutaboneka kwubwiza bwimiti yakozwe.Bijejwe.Kubera iyo mpamvu, hemejwe ko FDA itazemera ko ibiyobyabwenge byinjira ku isoko ry’abaguzi muri Amerika kugeza byemejwe ko iyi sosiyete ishobora guteza imbere ibibazo bifitanye isano.

Urebye imanza ebyiri zavuzwe haruguru, hari ikintu kimwe gihuriweho kigomba gukurura ibitekerezo byinganda, ni ukuvuga ko ikibazo cyumuhuza wo kugenzura isuku kitakemuwe neza, kandi nticyujuje ibyangombwa byemewe.Muyandi magambo: isuku nurufunguzo rwo kumenya umutekano wibiyobyabwenge, kandi ikora inzira yose ya farumasi.

Mubyukuri, hamwe nogushyira mubikorwa verisiyo nshya ya GMP (Imyitozo ngororamubiri myiza), hashyizweho ibisabwa byinshi kumasosiyete yimiti mubijyanye no kugenzura ubuziranenge bwimiti, cyane cyane mubice byihariye bya R&D, umusaruro, kugenzura ubuziranenge, no gutwara abantu.

Ku ruganda rukora imiti, GMP ni politiki yubahirizwa mu gihugu.Isosiyete idashoboye gupima cyangwa kubungabunga GMP mu gihe cyagenwe izahanishwa ibihano bitandukanye, harimo kuburira no guhagarika umusaruro.Ninzira igoye cyane kugirango ireme ryimiti ryujuje ubuziranenge.Muri byo, isuku ni kimwe mu bipimo by'ingenzi bipima niba ibigo bikorerwamo ibya farumasi bifite umusaruro uhamye. Ibigo byinshi bikorerwamo ibya farumasi ntibyemewe gukomeza umusaruro nyuma yo kugenzurwa n’inzego zibishinzwe.Impamvu yibanze nukuri ihuza nyamukuru-ibikoresho byogusukura ntabwo bisukuye.By'umwihariko, ibikoresho bya laboratoire bikozwe mu kirahure, plastiki, n'ibindi. Ntibishobora kwemeza neza ko byanduye neza.

Birakwiye gushimangira ko kuri ubu, ibigo byinshi bikorerwamo ibya farumasi byibanda gusa ku kwanduza no kuboneza urubyaro, ariko birengagiza irindi genzura ryingenzi ryo gusukura intambwe.Ibi biragaragara ko ari imyumvire itari yo.Nkuko mubizi ko amakuru yingenzi yo kugenzura isuku agomba no kubamo kwanduza no kuboneza urubyaro no gusukura neza laboratoire yimiti yimiti.Duhereye ku kintu runaka, icya nyuma ni ingenzi kuruta icyambere.Impamvu nuko gahunda yo kugenzura isuku isanzwe ikubiyemo uburyo bwiterambere ryicyiciro, icyiciro cyo gutegura gahunda, icyiciro cyo gushyira mubikorwa gahunda, nicyiciro cyo kugenzura imiterere.Izi ntambwe enye hafi ya zose zikorwa hafi yibyingenzi bigize GMP, nuburyo bwo "kugabanya umwanda no kwanduzanya kwanduye mugikorwa cyo gukora ibiyobyabwenge".Kuri buri cyiciro cyo guhuza igeragezwa, ntigishobora kandi gutandukana kurwego rwo koza ibirahuri nkibisabwa kugirango ubone ibisubizo nyabyo, bifatika kandi byizewe byo gutahura no gusesengura.

Ntabwo bishoboka ko laboratoire yibigo bireba ishaka kunoza ikibazo cyogusukura ibikoresho no kongera ingaruka zogusukura-birahagije kuzamura no gusimbuza uburyo bwambere bwo gukora intoki hamwe na sisitemu yo gukora isuku byikora.Kurugero, intangiriro no gukoresha aibikoresho byogukoresha ibirahurini kimwe mu bisubizo byiza.

Uwitekaibikoresho byogukoresha ibirahuriikoresha uburyo bwo gusukura spray.Ibisigara hejuru yububiko birashobora gukurwaho namazi ashyushye hamwe namavuta yo kwisiga kugirango ushire ibintu bisigaye, kugirango ibikoresho bishobore kongera kugira isuku kandi bimurika.Gukoresha umuvuduko mwinshi wamazi avuye mukuboko kwa spray hamwe nigitebo ,.Gukaraba LaboratwariIrashobora kunyura mumazi mu gice cyo gukaraba imbere binyuze mumashanyarazi azenguruka kugeza kumpande iyo ari yo yose yo gukaraba.Iyo amazi anyuze mumashanyarazi kugirango akore ubushyuhe bwinshi kandi akoreshwe muburyo bwinkingi yamazi, irashobora kwoza neza ibisigazwa byumwanda bitandukanye bifatanye hejuru yubwato bwakuweho, bityo bikagera kumugambi wo gusukura no gukama.Ntabwo aribyo gusa, ikoreshwa rya sisitemu yo gukaraba byikora kuriGukaraba muri Laboratoireifite isuku ryinshi (ibikoresho byogukoresha ibirahuriimirimo yo mucyiciro, uburyo bwo gukora isuku inshuro nyinshi), igipimo gito cyo kumena amacupa (guhuza n'imihindagurikire y'ikirere n'umuvuduko w'amazi, ubushyuhe bwimbere, nibindi), hamwe nuburyo bwinshi (Irashobora kwakira imiyoboro yipimisha, ibyokurya bya petri, flasque ya volumetric, flasque, gupima silinderi, nibindi . yubunini nuburyo butandukanye, kandi inzira yose irakorwa mubwenge, umutekano kandi wizewe (byashyizweho mbere yo gutumiza mu mahanga ibicuruzwa biturika bitarinze guturika, umuyoboro hamwe nubushyuhe, ntabwo byoroshye gupfundika Umwanda, hamwe na valve ikurikirana anti-leak, the igikoresho kizahita gifunga mugihe solenoid valve yananiwe). Byongeye, ilaboratoireirashobora guhita itanga amakuru yingenzi nkumuyoboro, TOC, amavuta yo kwisiga, nibindi, byoroheye abakozi bireba gukurikirana no kumenya iterambere ryogusukura no guhuza sisitemu yo gucapa no kuzigama nibyiza cyane, bitanga uburyo bworoshye bwo gukurikiranwa nyuma.

Imashini imesaifasha ibigo bikorerwamo ibya farumasi kugabanya kubyara kwanduzanya kwanduye, bifasha mugutezimbere buri sano ryikigo cy’imiti igenzura isuku, kandi ifasha n’amasosiyete yimiti kuzamura urwego rusange rwibikoresho bikoreshwa.Irimo kubahiriza byimazeyo ibisabwa byashyizweho na GMP mubihugu bitandukanye.Birakwiye kwerekanwa no gukoreshwa nabenshi mubigo bikorerwamo ibya farumasi.