CGMP ni iki?
Ibiyobyabwenge bya mbere GMP yavukiye muri Amerika mu 1963. Nyuma yo gusubirwamo byinshi kandi bikanonosora (CGMP (Ibikorwa byiza byo gukora) muri Amerika byahindutse umwe mu bahagarariye ikoranabuhanga riharanira iterambere muri GMP Umurima, ukina uruhare rukomeye mugukoresha ibiyobyabwenge neza kandi neza kwisi yose. Ubushinwa bwabanje bwasodira GMP itemanywaho mu 1988, kandi bigatsinda cyane ku nyungu eshatu kuva mu 1992, 1998, na 2010, bukeneye kurushaho gutera imbere. Mugihe cyimyaka irenga 20 yo guteza imbere imirimo ya GMP mu Bushinwa, gutangiza igitekerezo cya GMP kuzamura icyiciro cya GMP, kugerwaho icyiciro cyagezweho. Ariko, kubera gutinda gutangira GMP mu Bushinwa, habaye ibintu byinshi byagaragaye neza gMP ikoresha imashini, kandi ubusobanuro bwa GMP ntabwo bwinjizwa mubyasaruro nyabyo nubuyobozi bwiza.
Iterambere rya CGMP
Ibisabwa muri GMP iri muri China biracyari muri "Stage yambere" kandi nibisabwa byemewe. Kugirango imishinga yubushinwa yinjire ku isoko mpuzamahanga n'ibicuruzwa byabo, bagomba guhuza imicungire yabo n'amahame mpuzamahanga kugira ngo bamenyekane isoko. Nubwo guverinoma y'Ubushinwa itarashyira mu bikorwa ibigo bya farumasi gushyira mu bikorwa CGMP, ibi ntibisobanura ko nta byihutirwa mu Bushinwa ashyira mu bikorwa CGMP. Ibinyuranye nibyo, gucunga inzira yose yumusaruro dukurikije amahame ya CGMP nicyo gisabwa cyingenzi cyo kwimuka hagati mpuzamahanga. Kubwamahirwe, kuri ubu mu Bushinwa, ibigo bya farumasi bifite ingamba zo guteza imbere iterambere ryiterambere ryibisobanuro birebire byiri tegeko no kuyishyira mubikorwa.
Amateka yiterambere rya CGMP: CGMP yemewe ku rwego mpuzamahanga, haba muri Amerika cyangwa muri Amerika cyangwa Uburayi, kuri ubu, ubugenzuzi bujyanye na CGMP bujyanye na CGMP ihuriweho n'ibikoresho mpuzamahanga ku guhuza (Ich), bizwi kandi nka Ich Q q7a . Iri jambo ryaturutse mu nama mpuzamahanga yerekeye guhuza ibikoresho fatizo (Ich kuri Api) i Geneve, mu Busuwisi muri Nzeri 1997, iyobowe na FDA. Muri Werurwe 1998, yateguwe. Mu gatasi ko mu 1999, Umuryango w'ubumwe bw'ibihugu by'Uburayi na Amerika bageze ku masezerano yo kumenyekana kwa CGMP. Amasezerano amaze gukurikizwa, impande zombi zemeye kumenya ibyavuye mu cyemezo cya CGMP muri gahunda y'ibihugu by'ibikoresho fatizo. Kubigo bya API, amabwiriza ya CGMP mubyukuri ni ibintu byihariye bya Ich Q7a.
Itandukaniro riri hagati ya cgmp na gmp
CGMP ni urwego rwa GMP rwashyizwe mu bikorwa n'ibihugu nka Amerika, Uburayi, n'Ubuyapani, bizwi kandi ku izina rya "Imico Mpuzamahanga". Amahame ya CGMP ntabwo ahwanye na GMP yashyizwe mubikorwa mubushinwa.
Ishyirwa mu bikorwa ry'amabwiriza ya GMP mu Bushinwa ni urutonde rw'amabwiriza ya GMP akoreshwa mu bihugu bikiri mu nzira y'amajyambere yateguwe nande, hamwe no gushimangira cyane ibisabwa mu ibyuma by'abasaruro nkibikoresho byumusaruro.
CGMP yagabanijwe mu bihugu nka Amerika, Uburayi, n'Ubuyapani byibanze ku musaruro wa software, nko kugenzura ibikorwa by'abakora nuburyo bwo gukemura ibintu bitunguranye mubikorwa.
(1) Kugereranya na katalific yo kwerekana. Kubintu bitatu mubikorwa byo gutanga ibiyobyabwenge - sisitemu ya disiki, sisitemu ya software, nabakozi - CGMP muri Amerika ni Byoroheje kandi bifite ibice bike kuruta GMP mubushinwa. Ariko, hari itandukaniro ryingenzi mubisabwa byihutirwa kuri ibi bintu bitatu. GMP y'Ubushinwa ifite ibisabwa byinshi mu ibyuma, mu gihe CGMP ya Amerika ifite ibisabwa kuri software n'abakozi. Ni ukubera ko uburyo bwiza bwo kubyaza umusaruro biterwa n'iki gikorwa cy'Umukoresha, bityo uruhare rw'abakozi mu micungire ya GMP muri Amerika ni ngombwa kuruta ibyo ibikoresho byo mu ruganda.
(2) Kugereranya impamyabumenyi y'akazi. Mu rugendo rw'Ubushinwa, hari amabwiriza arambuye ku mpamyabumenyi (urwego rw'uburezi) rw'abakozi, ariko hari inzitizi nke ku nshingano z'abakozi; Muri sisitemu ya CGMP muri Amerika, impamyabumenyi (urwego rw'amahugurwa) y'abakozi baragufi kandi basobanutse, mu gihe inshingano z'abakozi barambuye. Iyi nshingano ahanini yemeza ko ibiyobyabwenge bitanga umusaruro.
(3) Kugereranya gukusanya icyitegererezo no kugenzura. GMP y'Ubushinwa iteganya gusa uburyo bukenewe bwo kugenzura, mu gihe CGMP muri Amerika igaragaza intambwe zose zigenzurwa, kugabanya urujijo no kwanduza ibiyobyabwenge mu byiciro bitandukanye, cyane cyane mu cyiciro kibisi, no gutanga icyizere cyo kunoza ubwiza bw'ibiyobyabwenge Inkomoko.
Ingorane zo gushyira mubikorwa cgmp
Guhindura GMP byimibare ya farumasi y'Ubushinwa yaroroshye. Ariko, haracyari ibibazo mugushyira mubikorwa CGMP, bigaragarira cyane cyane muburyo burambuye kandi butunganijwe.
Kurugero, isosiyete yimiti i Burayi irashaka kwinjira mu isoko rya Amerika ifite ibiyobyabwenge biteye ubwoba kandi bigatanga ibicuruzwa byemejwe na FDA. Mbere, mugihe cya synthesis yibikoresho, habaye gutandukana kwukuri muri bumwe mubushyuhe bubiri bwibikoresho byo kwigarurira. Nubwo umukoresha yari afite gutunganywa anasaba amabwiriza, ntibabyanditseho birambuye ku nyandiko. Ibicuruzwa bimaze gukorwa, abagenzuzi bafite ireme bagenzuye gusa umwanda uzwi mugihe cya Chromatographic Isesengura, kandi ntakibazo cyabonetse. Kubwibyo, hasohotse raporo y'ubugenzuzi bushoboye. Mu bugenzuzi, abayobozi ba FDA basanze ko termometero ari ukuri k'ukuri utujuje ibisabwa, ariko nta nyandiko zihuye zabonetse mu nyandiko. Mu gihe cyo kugenzura raporo y'ubugenzuzi bwiza, wasangaga isesengura rya chromatografi bitakozwe hakurikijwe igihe gikenewe gikenewe. Izi mbogamizi zose za CGMP ntizishobora guhunga igenzura, kandi uyu muti wananiwe kwinjira ku isoko rya Amerika.
FDA yemeje ko kunanirwa kubahiriza amabwiriza ya CGMP byangiza ubuzima bwabaguzi b'Abanyamerika. Niba hari gutandukana mubyukuri ukurikije ibisabwa na CGMP, hagomba gutegurwa iperereza, harimo kugenzura ibisubizo bishobora gutuma ubuturo buturuka ku bushyuhe buturuka ku bupfumu, no gufata amajwi gutandukana mubisobanuro. Ubugenzuzi bwibiyobyabwenge byose ni ukumenyekana gusa kandi bizwi ibintu bibi, kandi kubice bitazwi cyangwa bidafitanye isano, ntibishobora kumvikana binyuze muburyo buringaniye.
Mugihe dusuzuma ireme ryibiyobyabwenge, dukunze gukoresha ibipimo ngenderwaho bifite ireme kugirango tumenye niba ibiyobyabwenge byujuje ibisabwa cyangwa bishingiye ku mikorere no kugaragara kubicuruzwa. Ariko, muri CGMP, igitekerezo cyubwiza ni imyitwarire ihinduka muri byose umusaruro. Ibiyobyabwenge byujuje ibyangombwa ntibishobora byanze bikunze byujuje ibisabwa na CGMP, kuko haribishoboka byo gutandukana mubikorwa byayo. Niba nta bisabwa kugenzura neza kubikorwa byose, ingaruka zishobora kugaragara zidashobora kumenyekana na raporo nziza. Niyo mpamvu ishyirwa mu bikorwa rya CGMP ntabwo ryoroshye nkiryo.
Igihe cya nyuma: Jul-26-2023