ESE UZI ICYO cGMP ARI CYO?

cGMP ni iki?

GMP ya mbere ku isi ku biyobyabwenge yavukiye muri Leta Zunze Ubumwe za Amerika mu 1963. Nyuma y’ivugurura rikabije no gukomeza kunoza no kunoza FDA yo muri Amerika, cGMP (Ubucuruzi Bwiza Bugezweho) muri Leta Zunze Ubumwe za Amerika yabaye imwe mu zihagarariye ikoranabuhanga rigezweho mu rwego rwa GMP, igira uruhare runini mu ikoreshwa ry’imiti mu buryo bwizewe kandi bunoze ku isi. Ubushinwa bwatangaje bwa mbere GMP y’imiti yemewe n’amategeko mu 1988, kandi ahanini imaze kuvugururwa inshuro eshatu kuva mu 1992, 1998, na 2010, ibyo bikaba bigikeneye kunozwa kurushaho. Mu myaka irenga 20 yo guteza imbere akazi ka GMP y’imiti mu Bushinwa, kuva ku gutangiza igitekerezo cya GMP kugeza ku guteza imbere icyemezo cya GMP, hari ibyagezweho mu byiciro. Ariko, bitewe n’uko GMP yatangiye mu Bushinwa mu gihe gito, habayeho ibintu byinshi byo gukoresha GMP mu buryo bwa tekiniki, kandi icyo GMP isobanura nticyashyizwe mu buryo nyabwo mu musaruro nyakuri no mu micungire myiza.

 

Iterambere rya cGMP

Ibisabwa muri iki gihe bya GMP mu Bushinwa biracyari mu "gihe cya mbere" kandi ni ibisabwa gusa. Kugira ngo ibigo by'Abashinwa byinjire ku isoko mpuzamahanga n'ibicuruzwa byabyo, bigomba guhuza imicungire y'umusaruro wabyo n'amahame mpuzamahanga kugira ngo bimenyekane ku isoko. Nubwo guverinoma y'Ubushinwa itarategeka ibigo by'imiti gushyira mu bikorwa cGMP, ibi ntibivuze ko nta bwihutirwa ko Ubushinwa bushyira mu bikorwa cGMP. Ahubwo, gucunga inzira yose yo gukora hakurikijwe amahame ya cGMP ni ngombwa kugira ngo tugere ku rwego mpuzamahanga. Ku bw'amahirwe, ubu mu Bushinwa, ibigo by'imiti bifite ingamba zo guteza imbere ibintu bireba imbere byabonye akamaro k'igihe kirekire k'iri tegeko kandi birishyira mu bikorwa.

Amateka y’Iterambere rya cGMP: CGMP yemewe ku rwego mpuzamahanga, haba muri Leta Zunze Ubumwe za Amerika cyangwa i Burayi, ubu igenzura ry’iyubahirizwa rya cGMP ku bibanza byakorewemo rikurikiza amabwiriza ya cGMP ku bikoresho fatizo yateguwe n’Inama Mpuzamahanga ku Ihuzabikorwa (ICH), izwi kandi nka ICH Q7A. Ibi bisobanuro byaturutse ku Nama Mpuzamahanga ku Ihuzabikorwa ry’Ibikoresho fatizo (ICH for API) yabereye i Genève, mu Busuwisi muri Nzeri 1997. Muri Werurwe 1998, iyobowe na FDA yo muri Amerika, hashyizweho "cGMP ku bikoresho fatizo", ICH Q7A. Mu gihe cy’impeshyi ya 1999, Umuryango w’Ubumwe bw’u Burayi na Leta Zunze Ubumwe za Amerika byumvikanye ku masezerano yo kwemeza cGMP ku bikoresho fatizo. Nyuma y’uko amasezerano atangiye gukurikizwa, impande zombi zemeye kwemeza ibyavuye mu cyemezo cya cGMP cy’undi mu nzira y’ubucuruzi bw’ibikoresho fatizo. Ku bigo bya API, amabwiriza ya cGMP ni yo mu by’ukuri ari yo akubiye muri ICH Q7A.

 

Itandukaniro riri hagati ya cGMP na GMP

CGMP ni igipimo ngenderwaho cya GMP gishyirwa mu bikorwa n'ibihugu nka Leta Zunze Ubumwe za Amerika, Uburayi, n'Ubuyapani, bizwi kandi nka "igipimo ngenderwaho mpuzamahanga cya GMP". Ibipimo ngenderwaho bya cGMP ntabwo bingana n'ibipimo ngenderwaho bya GMP bishyirwa mu bikorwa mu Bushinwa.

Ishyirwa mu bikorwa ry’amabwiriza ya GMP mu Bushinwa ni urutonde rw’amabwiriza ya GMP akoreshwa mu bihugu biri mu nzira y’amajyambere yashyizweho na OMS, hibandwa cyane cyane ku bisabwa ku bikoresho byo mu nganda nk’ibikoresho byo mu nganda.

Gahunda ya cGMP ishyirwa mu bikorwa mu bihugu nka Leta Zunze Ubumwe za Amerika, Uburayi, n'Ubuyapani yibanda ku gukora porogaramu za mudasobwa, nko kugenzura ibikorwa by'abakora porogaramu n'uburyo bwo guhangana n'ibintu bitunguranye mu gikorwa cyo kuzikora.

(1) Kugereranya kataloge z’ibipimo by’impamyabumenyi. Ku bintu bitatu biri mu ikorwa ry’imiti - sisitemu z’ibikoresho, sisitemu za porogaramu, n’abakozi - cGMP muri Leta Zunze Ubumwe za Amerika yoroshye kandi ifite ibice bike ugereranyije na GMP mu Bushinwa. Ariko, hari itandukaniro rinini mu bisabwa kuri ibi bintu bitatu. GMP yo mu Bushinwa ifite ibisabwa byinshi ku bikoresho, mu gihe cGMP yo muri Leta Zunze Ubumwe za Amerika ifite ibisabwa byinshi ku bikoresho bya porogaramu n’abakozi. Ibi biterwa nuko ubwiza bw’imiti buterwa ahanini n’imikorere y’umukoresha, bityo uruhare rw’abakozi mu micungire ya GMP muri Leta Zunze Ubumwe za Amerika ni ingenzi kurusha urw’ibikoresho by’uruganda.

(2) Kugereranya impamyabushobozi z'akazi. Muri GMP y'Ubushinwa, hari amabwiriza arambuye ku mpamyabushobozi (urwego rw'uburezi) z'abakozi, ariko hari imbogamizi nke ku nshingano z'abakozi; Muri sisitemu ya cGMP muri Leta Zunze Ubumwe za Amerika, impamyabushobozi (urwego rw'amahugurwa) z'abakozi zirasobanutse neza kandi zisobanutse, mu gihe inshingano z'abakozi zisobanurwa neza. Iyi sisitemu y'inshingano ahanini igenzura ireme ry'umusaruro w'imiti.

(3) Kugereranya icyegeranyo n'igenzura ry'ibipimo. GMP yo mu Bushinwa igena gusa inzira zikenewe zo kugenzura, mu gihe cGMP yo muri Leta Zunze Ubumwe za Amerika igena intambwe zose zo kugenzura n'uburyo bwo kubigenzura mu buryo burambuye, ikagabanya urujijo n'ubwandu bw'imiti mu byiciro bitandukanye, cyane cyane mu cyiciro cy'ibikoresho fatizo, kandi igatanga icyizere cyo kunoza ubuziranenge bw'imiti ituruka aho ikomoka.

 

Ingorane mu gushyira mu bikorwa cGMP

Impinduka za GMP mu bigo by’imiti byo mu Bushinwa zagenze neza. Ariko, haracyari imbogamizi mu gushyira mu bikorwa cGMP, ahanini bigaragarira mu kuri kw'ibisobanuro birambuye n'imikorere.

Urugero, ikigo cy’imiti mu Burayi kirashaka kwinjira ku isoko rya Amerika gifite umuti w’ibikoresho fatizo utanga icyizere, maze gitanga umusaruro wemewe na FDA yo muri Amerika. Mbere yaho, mu gihe cyo gukora isesengura ry’ibikoresho fatizo, habayeho ihinduka ry’ubuziranenge muri kimwe mu bipimo bibiri by’ubushyuhe by’ikigega cy’ingufu. Nubwo umukozi yari yarakoze akanasaba amabwiriza, ntibayanditse mu buryo burambuye ku nyandiko z’umusaruro. Nyuma y’uko ibicuruzwa bikozwe, abagenzuzi b’ubuziranenge bagenzuraga gusa umwanda uzwi mu gihe cyo gusesengura chromatografiya, kandi nta kibazo cyabonetse. Kubwibyo, raporo y’igenzura ryemewe yatanzwe. Mu igenzura, abayobozi ba FDA basanze ubuziranenge bwa thermometer budahuye n’ibyasabwaga, ariko nta nyandiko zijyanye na yo zabonetse mu nyandiko z’umusaruro. Mu gihe cyo kugenzura raporo y’igenzura ry’ubuziranenge, byagaragaye ko isesengura rya chromatografiya ritakozwe hakurikijwe igihe cyagenwe. Ibi byose binyuranyije na cGMP ntibishobora guhunga isuzuma ry’abagenzuzi, kandi uyu muti amaherezo wananiwe kwinjira ku isoko rya Amerika.

FDA yemeje ko kutubahiriza amabwiriza ya cGMP byagira ingaruka mbi ku buzima bw'abaguzi b'Abanyamerika. Iyo habayeho kunyuranya mu kuri hakurikijwe ibisabwa na cGMP, hakwiye gutegurwa iperereza ryinshi, harimo no kugenzura ibisubizo bishoboka byo kunyuranya mu kuri kw'ubushyuhe, no kwandika kunyuranya mu buryo busobanuwe. Igenzura ryose ry'imiti rikorerwa gusa ku mwanda uzwi n'ibintu bibi bizwi, kandi ku bice bitazwi byangiza cyangwa bidafite aho bihuriye, ntibishobora kumenyekana neza binyuze mu buryo busanzwe.

Mu gusuzuma ubwiza bw'umuti, akenshi dukoresha ibipimo ngenderwaho byo kugenzura ubwiza kugira ngo tumenye niba umuti wujuje ibisabwa cyangwa hashingiwe ku bushobozi n'isura y'umuti. Ariko, muri cGMP, igitekerezo cy'ubwiza ni ihame ry'imyitwarire rikorwa mu gikorwa cyose. Umuti wujuje ibisabwa ushobora kuba utujuje ibisabwa na cGMP, kuko hari amahirwe yo kunyura mu nzira yawo. Iyo nta mategeko akomeye agenga imikorere, ibyago bishobora kubaho ntibishobora kumenyekana hakoreshejwe raporo z'ubwiza. Niyo mpamvu ishyirwa mu bikorwa rya cGMP ritaroroshye nkabyo.