Mu minsi ishize, ikigo gishinzwe imiti cyakoreweho iperereza kandi gikemurwa n’inzego zibishinzwe kubera ingaruka zishobora guteza umutekano muke mu buryo bwo gucunga ubuziranenge, bituma ikigo gishinzwe imiti gihagarika gukora ako kanya kugira ngo gikosorwe, ndetse n’icyemezo cy’umwimerere cya “drug GMP” cy’ikigo nacyo cyakuweho.

Ku bw'amahirwe, muri Nzeri 2020, Ikigo gishinzwe Ibiribwa n'Imiti muri Amerika (FDA) cyasohoye ibaruwa yo kwihanangiriza ikigo gishinzwe imiti irwanya udukoko mu Buhinde. Iyo baruwa yaburiye bikomeye ko ikigo kitashyize mu bikorwa neza uburyo bwo kugenzura isuku mu gihe cyo gukora umuti ugezweho, ahubwo cyibanze ku kurandura ku mugaragaro bagiteri, byatera ibyago byo kwandura izindi ngaruka zo gusukura no kutaboneka kw'ubuziranenge bw'imiti yakozwe. Biremewe. Kubwibyo, byemejwe ko Ikigo gishinzwe Imari n'Igenamigambi kitazemera ko uyu muti winjira ku isoko ry'abaguzi muri Leta Zunze Ubumwe za Amerika kugeza igihe byemejwe ko ikigo gishobora kunoza ibibazo bifitanye isano.

Urebye muri izi ngingo ebyiri zavuzwe haruguru, hari ikintu kimwe gihuriweho kigomba gukurura ibitekerezo by'inganda, ni ukuvuga ko ikibazo cyo kugenzura isuku kitakemutse neza, kandi nticyujuje ibisabwa byemewe n'amategeko. Mu yandi magambo: isuku ni ingenzi mu kumenya umutekano w'imiti, kandi inyura mu nzira yose ya farumasi.

Mu by’ukuri, hamwe n’ishyirwa mu bikorwa rya verisiyo nshya ya GMP (Uburyo bwiza bwo gukora), hashyizweho ibisabwa byinshi ku bigo bicuruza imiti mu bijyanye no kugenzura ubuziranenge bw’imiti, cyane cyane mu nzego zihariye z’ubushakashatsi n’iterambere, umusaruro, kugenzura ubuziranenge, no gutwara abantu.

Ku kigo gishinzwe imiti, GMP ni politiki yubahirizwa mu gihugu hose. Ibigo bidashobora gushyira mu bikorwa cyangwa ngo bikomeze GMP mu gihe cyagenwe bizahanwa mu buryo butandukanye, harimo no kwihanangirizwa no guhagarika gukora. Ni inzira igoye cyane kugira ngo ubuziranenge bw'imiti bugere ku gipimo cyemewe. Muri byo, isuku ni kimwe mu bimenyetso by'ingenzi bipima niba ibigo bikora imiti bifite ubushobozi bwo gukora buhamye. Ibigo byinshi bikora imiti ntibyemewe gukomeza gukora nyuma yo gusuzumwa n'amashami abishinzwe. Impamvu y'ingenzi ni isano nyamukuru - ibikoresho byo gusukura ntibisukuye. By'umwihariko, ibikoresho byo muri laboratwari bikozwe mu kirahure, pulasitiki, nibindi. Ntibishobora kwemeza ko ibisigazwa by'imiti bisukurwa neza.

Ni ngombwa gushimangira ko muri iki gihe, amasosiyete menshi acuruza imiti yibanda gusa ku gusukura no gukaraba, ariko akirengagiza ikindi gikorwa cy'ingenzi cyo kugenzura intambwe zo gusukura. Ibi biragaragara ko ari ukwibeshya. Nkuko mubizi, ibisobanuro by'ingenzi by'igenzura ry'isuku bigomba no kuba birimo gusukura no gukaraba no gusukura neza laboratwari y'isosiyete icuruza imiti. Mu buryo runaka, icya nyuma ni ingenzi kurusha icya mbere. Impamvu ni uko inzira yo kugenzura isuku ikunze kuba ikubiyemo icyiciro cyo guteza imbere uburyo, icyiciro cyo gutegura gahunda, icyiciro cyo gushyira mu bikorwa gahunda, n'icyiciro cyo kubungabunga uko ibintu bimeze. Ibi byiciro bine hafi ya byose bikorwa hakurikijwe ibikubiye muri GMP, ari byo "kugabanya umwanda no kwanduzanya mu gikorwa cyo gukora imiti". Kuri buri cyiciro cy'isano ry'igerageza ryo kugenzura, ntibitandukanywa n'amahame yo gukaraba ibikoresho by'ikirahure nk'igisabwa kugira ngo haboneke ibisubizo nyabyo, byiza kandi byizewe byo kubona no gusesengura.

Ntibishoboka ko laboratwari z'ibigo bireba zishaka kunoza ikibazo cyo gusukura ibikoresho no kunoza uburyo bwo gusukura - birahagije kuvugurura no gusimbuza uburyo bwa mbere bwo gusukura intoki n'uburyo bwo gusukura bwikora. Urugero, gutangiza no gukoresha uburyo bwo gusukuraimashini imesa ibikoresho by'ikirahure yikorani kimwe mu bisubizo byiza.

Itsindaimashini imesa ibikoresho by'ikirahure yikoraikoresha uburyo bwo gusukura imashini itera amazi. Ibisigazwa biri ku buso bw'ibikoresho bishobora gukurwaho n'amazi ashyushye n'amavuta yo kwisiga kugira ngo binywe ibisigaye, bityo ibikoresho bishobore kongera kuba bisukuye kandi bibe bishyushye. Ikoresheje amazi afite umuvuduko mwinshi ava ku kuboko kwa spray n'agasanduku k'igikapu,Umuyoboro woza muri laboratwariishobora kunyuza amazi mu buryo butaziguye mu gice cyo kumesamo amazi binyuze mu ipompo yo kumesa izenguruka kugeza ku mfuruka iyo ari yo yose y'aho amazi yo kumesa. Iyo amazi anyuze mu gishyushya kugira ngo akore ubushyuhe bwinshi kandi agakoreshwa nk'inkingi y'amazi, ashobora gukaraba neza ibisigazwa bitandukanye by'imyanda bifatanye n'igice cyo hejuru cy'icyuma gikuraho amazi, bityo bikagera ku ntego yo gusukura no kumisha. Si ibyo gusa, ahubwo no gukoresha uburyo bwo kumesa bwikora kuriUmuyoboro wo koza muri laboratwariifite ubushobozi bwo gusukura neza cyane (imashini imesa ibikoresho by'ikirahure yikoraImirimo yo gukora mu matsinda, gusukura inshuro nyinshi), umuvuduko muto wo gusenya amacupa (guhindura umuvuduko w'amazi, ubushyuhe bw'imbere, nibindi), hamwe n'uburyo bwinshi bwo gukora (Ishobora kwakira imiyoboro yo gupima, amasahani ya petri, amacupa y'ubunini, amacupa y'inyuma, silindiri zo gupima, nibindi by'ingano n'imiterere bitandukanye, kandi igikorwa cyose gikorwa neza, gitekanye kandi cyizewe (umuyoboro w'amazi winjiriramo udashobora guturika, umuvuduko n'ubushyuhe, ntabwo byoroshye kuwupfundikaho umwanda, hamwe na valve igenzura irinda gusohoka, igikoresho kizahita gifunga iyo valve ya solenoid inaniwe). Byongeye kandi,imashini yoza ibikoresho by'ikirahure muri laboratwariishobora guhita yerekana amakuru y'ingenzi nko kuyobora amazi, TOC, ubwinshi bw'amavuta yo koza, nibindi, byorohereza abakozi babishinzwe gukurikirana no kumenya neza aho isuku igeze no guhuza sisitemu kugira ngo icapishe kandi ibike ni ingirakamaro cyane, bitanga uburyo bworoshye bwo gukurikirana nyuma.

Imashini imesa muri laboratwariIfasha ibigo bicuruza imiti kugabanya kwanduzanya kw'imiti, ifasha kunoza buri sano ry'igenzura ry'isuku ry'ikigo gicuruza imiti, kandi ifasha ibigo bicuruza imiti kunoza urwego rw'ibikoresho muri rusange. Ikurikiza amabwiriza yashyizweho na GMP mu bihugu bitandukanye. Ikwiye kwitabwaho no gukoreshwa n'ibigo byinshi bicuruza imiti.