CGMP ni iki?
Ibiyobyabwenge bya mbere ku isi GMP yavukiye muri Amerika mu 1963. Nyuma yo gusubiramo byinshi no gukomeza gutunganywa no kunonosorwa na FDA yo muri Amerika, cGMP (Ibikorwa byiza byo gukora ubu) muri Amerika yabaye umwe mu bahagarariye ikoranabuhanga ryateye imbere muri GMP umurima, ugira uruhare runini mugukoresha neza kandi neza ibiyobyabwenge kwisi yose.Ubushinwa bwatangaje bwa mbere ibiyobyabwenge byemewe n'amategeko GMP mu 1988, kandi byahinduwe cyane kuva mu 1992, 1998, na 2010, bigikeneye kurushaho kunozwa.Mu myaka irenga 20 yo guteza imbere ibiyobyabwenge bya GMP mu Bushinwa, kuva mu kumenyekanisha igitekerezo cya GMP kugeza guteza imbere icyemezo cya GMP, ibyagezweho mu byiciro.Ariko, kubera gutangira gutinda kwa GMP mubushinwa, habaye ibintu byinshi byo gukoresha imashini ya GMP, kandi ibisobanuro bya GMP ntabwo byinjijwe mubyukuri mubikorwa no gucunga neza.
Iterambere rya cGMP
Ibisabwa muri GMP muri iki gihe biracyari mu "cyiciro cya mbere" kandi ni ibisabwa gusa.Kugira ngo inganda z’Abashinwa zinjire ku isoko mpuzamahanga n’ibicuruzwa byazo, bagomba guhuza imicungire y’umusaruro n’ibipimo mpuzamahanga kugira ngo bamenyekane ku isoko.Nubwo guverinoma y'Ubushinwa itarategeka ibigo by'imiti gushyira mu bikorwa cGMP, ntibisobanuye ko nta byihutirwa Ubushinwa bushyira mu bikorwa cGMP.Ibinyuranye, gucunga inzira zose zakozwe ukurikije amahame ya cGMP nicyo gisabwa cyingenzi kugirango tugere ku rwego mpuzamahanga.Ku bw'amahirwe, kuri ubu mu Bushinwa, uruganda rukora imiti rufite ingamba zo kwiteza imbere rumaze kubona akamaro k’igihe kirekire cy’aya mabwiriza kandi rushyira mu bikorwa.
Amateka yiterambere rya cGMP: cGMP yemewe ku rwego mpuzamahanga, haba muri Amerika cyangwa mu Burayi, kuri ubu igenzura ryubahirizwa rya cGMP ahakorerwa ibicuruzwa rikurikiza ibisobanuro bya cGMP bihujwe ku bikoresho fatizo byateguwe n’inama mpuzamahanga ku guhuza (ICH), bizwi kandi nka ICH Q7A .Ibi bisobanuro byaturutse mu nama mpuzamahanga yerekeye guhuza ibikoresho bito (ICH for API) yabereye i Geneve mu Busuwisi muri Nzeri 1997. Muri Werurwe 1998, iyobowe na Amerika FDA, "cGMP y’ibikoresho fatizo", ICH Q7A, yateguwe.Mu gatasi ka 1999, Umuryango w’ubumwe bw’ibihugu by’Uburayi na Amerika byageze ku masezerano yo kumenyekanisha cGMP ku bikoresho fatizo.Amasezerano amaze gukurikizwa, impande zombi zemeye kumenya ibisubizo bya cGMP bya buri wese mubikorwa byubucuruzi bwibikoresho fatizo.Ku masosiyete ya API, amabwiriza ya cGMP mubyukuri nibyo bikubiye muri ICH Q7A.
Itandukaniro hagati ya cGMP na GMP
CGMP ni igipimo cya GMP gishyirwa mu bikorwa n'ibihugu nka Amerika, Uburayi, n'Ubuyapani, bizwi kandi nka "mpuzamahanga GMP mpuzamahanga".cGMP ibipimo ntabwo bihwanye na GMP yashyizwe mubikorwa mubushinwa.
Ishyirwa mu bikorwa ry’amabwiriza ya GMP mu Bushinwa ni urutonde rw’amabwiriza ya GMP akurikizwa mu bihugu biri mu nzira y'amajyambere yashyizweho na OMS, hibandwa cyane cyane ku bisabwa ku bikoresho by’ibicuruzwa nkibikoresho by’umusaruro.
CGMP yashyizwe mu bikorwa mu bihugu nka Amerika, Uburayi, n'Ubuyapani yibanda ku gukora porogaramu, nko kugenzura ibikorwa by'abakora n'uburyo bwo gukemura ibibazo bitunguranye mu gihe cyo gukora.
(1) Kugereranya urutonde rwimpamyabumenyi.Kubintu bitatu mubikorwa byo gukora ibiyobyabwenge - sisitemu yibikoresho, sisitemu ya software, n'abakozi - cGMP muri Amerika iroroshye kandi ifite ibice bike ugereranije na GMP mubushinwa.Ariko, hariho itandukaniro rikomeye mubisabwa byihariye kuri ibi bintu bitatu.GMP y'Ubushinwa ifite byinshi isabwa ku byuma, mu gihe cGMP yo muri Amerika ifite ibisabwa byinshi kuri software n'abakozi.Ni ukubera ko ubwiza bw’ibiyobyabwenge biterwa ahanini n’imikorere yabakoresha, bityo uruhare rwabakozi mu micungire ya GMP muri Amerika ni ingenzi cyane kuruta ibikoresho by’uruganda.
(2) Kugereranya impamyabumenyi y'akazi.Muri GMP y'Ubushinwa, hari amabwiriza arambuye ku bijyanye n'ubushobozi (urwego rw'uburezi) rw'abakozi, ariko hari imbogamizi nke ku nshingano z'abakozi;Muri sisitemu ya cGMP muri Amerika, impamyabumenyi (urwego rwamahugurwa) y abakozi irasobanutse kandi irasobanutse, mugihe inshingano zabakozi zirasobanutse neza.Ubu buryo bwo gutanga inshingano ahanini butanga umusaruro w’ibiyobyabwenge.
(3) Kugereranya icyegeranyo cyo gukusanya no kugenzura.GMP yo mu Bushinwa iteganya gusa uburyo bukenewe bwo kugenzura, mu gihe cGMP yo muri Amerika igaragaza inzira zose n’ubugenzuzi ku buryo burambuye, bigabanya urujijo no kwanduza ibiyobyabwenge mu byiciro bitandukanye, cyane cyane mu bikoresho fatizo, kandi bitanga icyizere cyo kuzamura ireme ry’ibiyobyabwenge kuva isoko.
Ingorane zo gushyira mubikorwa cGMP
Guhindura GMP inganda zimiti yubushinwa byagenze neza.Nubwo bimeze bityo ariko, haracyari imbogamizi mugushira mubikorwa cGMP, cyane cyane bigaragarira mubyukuri kwamakuru arambuye.
Kurugero, uruganda rukora imiti i Burayi rurashaka kwinjira ku isoko ry’Amerika hamwe n’ibiyobyabwenge byizewe kandi bigatanga ibicuruzwa byemewe muri FDA yo muri Amerika.Mbere, mugihe cyo gutunganya ibikoresho fatizo, habaho gutandukana kwukuri muri kimwe mu bipimo bibiri by'ubushyuhe bwa tank.Nubwo uyikoresha yatunganije agasaba amabwiriza, ntabwo bayanditse muburyo burambuye kubyakozwe.Ibicuruzwa bimaze gukorwa, abagenzuzi b'ubuziranenge basuzumye gusa umwanda uzwi mugihe cyo gusesengura chromatografique, kandi ntakibazo cyabonetse.Kubera iyo mpamvu, raporo yubugenzuzi yujuje ibyangombwa yatanzwe.Mu gihe cy’igenzura, abayobozi ba FDA basanze ubunyangamugayo bwa termometero butujuje ibyangombwa, ariko nta nyandiko ihuye yabonetse mu gitabo cy’ibicuruzwa.Mu gihe cyo kugenzura raporo y’ubugenzuzi bw’ubuziranenge, byagaragaye ko isesengura rya chromatografique ridakozwe hakurikijwe igihe gikenewe.Iri hohoterwa ryose rya cGMP ntirishobora guhunga ubugenzuzi, kandi uyu muti wananiwe kwinjira ku isoko ry’Amerika.
FDA yemeje ko kutubahiriza amabwiriza ya cGMP byangiza ubuzima bw'abaguzi b'Abanyamerika.Niba hari gutandukana mubyukuri ukurikije ibisabwa bya cGMP, hagomba gutegurwa irindi perereza, harimo kugenzura ibisubizo bishoboka ko ubushyuhe bwatandukanijwe nukuri, no kwandika gutandukana kubisobanuro byakozwe.Igenzura ryose ryibiyobyabwenge rigenewe gusa umwanda uzwi nibintu bizwi bizwi, kandi kubintu bitazwi byangiza cyangwa bidafitanye isano, ntibishobora kumenyekana byimazeyo hakoreshejwe uburyo buriho.
Iyo dusuzumye ubuziranenge bwibiyobyabwenge, dukoresha kenshi ibipimo ngenderwaho byo kugenzura ubuziranenge kugirango tumenye niba imiti yujuje ibisabwa cyangwa ishingiye ku mikorere n’imiterere y’ibicuruzwa.Ariko, muri cGMP, igitekerezo cyubwiza ni ihame ryimyitwarire ikora mubikorwa byose.Ibiyobyabwenge byujuje ibyangombwa ntibishobora byanze bikunze byujuje ibisabwa na cGMP, kuko haribishoboka gutandukana mubikorwa byayo.Niba nta tegeko rikomeye risabwa kubikorwa byose, ingaruka zishobora kutamenyekana na raporo nziza.Niyo mpamvu gukora cGMP bitoroshye nkibyo.
Igihe cyoherejwe: Nyakanga-26-2023