Yini i-cGMP?
Umuthi wokuqala emhlabeni i-GMP wazalelwa e-United States ngo-1963. Ngemva kokubuyekezwa okuningana kanye nokunothiswa okuqhubekayo nokuthuthukiswa kwe-US FDA, i-cGMP (Imikhuba Yamanje Yokukhiqiza Okuhle) e-United States isibe ngomunye wabamele ubuchwepheshe obuthuthukisiwe ku-GMP. field, edlala indima ekhulayo ekusetshenzisweni kwezidakamizwa okuphephile nangempumelelo emhlabeni jikelele. I-China yaqala ukumemezela umuthi osemthethweni we-GMP ngo-1988, futhi isike yabuyekezwa kathathu kusukela ngo-1992, 1998, nango-2010, okusadinga ukuthuthukiswa okwengeziwe. Phakathi neminyaka engaphezu kwengu-20 yokuthuthukisa umsebenzi we-GMP yezidakamizwa e-China, kusukela ekwethulweni komqondo we-GMP kuya ekuthuthukiseni isitifiketi se-GMP, izimpumelelo ezifinyelelwe ngezigaba ziye zazuzwa. Kodwa-ke, ngenxa yokuphela kwesikhathi kwe-GMP e-China, kube nezigigaba eziningi zokusebenzisa i-GMP, futhi incazelo ye-GMP ayizange ihlanganiswe ngempela ekukhiqizweni nasekuphathweni kwekhwalithi.
Ukuthuthukiswa kwe-cGMP
Izidingo zamanje ze-GMP e-China zisese "sigabeni sokuqala" futhi ziyizidingo ezisemthethweni kuphela. Ukuze amabhizinisi aseShayina akwazi ukungena emakethe yamazwe ngamazwe nemikhiqizo yawo, kufanele aqondise ukuphathwa kwawo kokukhiqiza namazinga omhlaba ukuze athole ukuqashelwa kwemakethe. Nakuba uhulumeni waseShayina engakagunyazi izinkampani ezenza imithi ukuthi zenze i-cGMP, lokhu akusho ukuthi akukho ukuphuthuma kokuthi i-China isebenzise i-cGMP. Ngokuphambene nalokho, ukuphatha yonke inqubo yokukhiqiza ngokwezindinganiso ze-cGMP kuyisidingo esibalulekile sokudlulela ekuhwebeni kwamazwe ngamazwe. Ngenhlanhla, okwamanje e-China, izinkampani zemithi ezinamasu okuthuthukiswa okubheke phambili ziye zaqaphela ukubaluleka kwesikhathi eside kwalo mthetho futhi zawusebenzisa.
Umlando Wokuthuthukiswa kwe-cGMP: I-cGMP eyamukelwe emhlabeni wonke, kungakhathaliseki ukuthi ise-United States noma e-Europe, okwamanje ukuhlolwa kokuthobela i-cGMP ezindaweni zokukhiqiza kulandela ukucaciswa okuhlanganisiwe kwe-cGMP yezinto zokusetshenziswa ezakhiwe yi-International Conference on Harmonization (ICH), eyaziwa nangokuthi ICH Q7A. . Lokhu kucaciswa kwavela eNgqungqutheleni Yamazwe Ngamazwe Yokuvunyelaniswa Kwezinto Zokuluhlaza (ICH ye-API) e-Geneva, eSwitzerland ngoSepthemba 1997. NgoMashi 1998, eholwa yi-US FDA, "cGMP yezinto zokusetshenziswa" ezihlanganisiwe, ICH Q7A, yabhalwa. Ekwindla ka-1999, i-European Union kanye ne-United States bafinyelela isivumelwano sokuqashelwa kwe-cGMP ngezinto zokusetshenziswa. Ngemuva kokuthi isivumelwano siqale ukusebenza, zombili izinhlangothi zavumelana ukuqaphela imiphumela yesitifiketi se-cGMP somunye nomunye enqubweni yokuhweba yezinto ezingavuthiwe. Ezinkampanini ze-API, imithetho ye-cGMP empeleni ingukuqukethwe okuthile kwe-ICH Q7A.
Umehluko phakathi kwe-cGMP ne-GMP
I-CGMP indinganiso ye-GMP esetshenziswa amazwe afana ne-United States, i-Europe, ne-Japan, eyaziwa nangokuthi "izinga le-GMP lamazwe ngamazwe". Amazinga e-cGMP awalingani namazinga e-GMP asetshenziswa eChina.
Ukuqaliswa kwemithetho ye-GMP e-China isethi yemithetho ye-GMP esebenza emazweni asathuthuka eyakhiwe yi-WHO, egcizelela ngokukhethekile izidingo zehardware yokukhiqiza efana nemishini yokukhiqiza.
I-cGMP esetshenziswa emazweni afana ne-United States, i-Europe, ne-Japan igxile ekukhiqizweni kwesofthiwe, njengokulawula izenzo zama-opharetha nendlela yokusingatha izehlakalo ezingalindelekile kunqubo yokukhiqiza.
(1) Ukuqhathaniswa kwamakhathalogi ezicaciso zesitifiketi. Ezicini ezintathu zenqubo yokukhiqiza izidakamizwa - izinhlelo zehadiwe, izinhlelo zesofthiwe, nabasebenzi - i-cGMP e-United States ilula futhi inezahluko ezimbalwa kune-GMP e-China. Nokho, kunomehluko omkhulu ezidingweni ezingokwemvelo zalezi zici ezintathu. I-GMP yaseChina inezidingo ezengeziwe zehadiwe, kuyilapho i-cGMP yase-United States inezidingo ezengeziwe zesofthiwe nabasebenzi. Lokhu kungenxa yokuthi ikhwalithi yokukhiqiza yezidakamizwa ngokuyisisekelo incike ekusebenzeni komsebenzisi, ngakho indima yabasebenzi ekuphathweni kwe-GMP e-United States ibaluleke kakhulu kunaleyo yezisetshenziswa zasefekthri.
(2) Ukuqhathaniswa kweziqu zemisebenzi. Ku-GMP yaseShayina, kunemithethonqubo enemininingwane mayelana neziqu (izinga lezemfundo) zabasebenzi, kodwa kunezingqinamba ezimbalwa emisebenzini yabasebenzi; Ohlelweni lwe-cGMP e-United States, iziqu (izinga lokuqeqeshwa) zabasebenzi zifushane futhi zicacile, kuyilapho izibopho zabasebenzi zinemininingwane eqinile. Lolu hlelo lwesibopho luqinisekisa kakhulu izinga lokukhiqizwa kwezidakamizwa.
(3) Ukuqhathaniswa kokuqoqwa kwesampula nokuhlolwa. I-GMP yaseChina ibeka kuphela izinqubo zokuhlola ezidingekayo, kuyilapho i-cGMP e-United States icacisa zonke izinyathelo nezindlela zokuhlola ngokuningiliziwe, ukunciphisa ukudideka nokungcoliswa kwezidakamizwa ngezigaba ezihlukahlukene, ikakhulukazi esigabeni sezinto ezingavuthiwe, futhi inikeza isiqinisekiso sokuthuthukisa ikhwalithi yezidakamizwa umthombo.
Ubunzima bokusebenzisa i-cGMP
Ukuguqulwa kwe-GMP kwamabhizinisi aseShayina emithi kube lula uma kuqhathaniswa. Kodwa-ke, kusenezinselelo ekusebenziseni i-cGMP, ebonakala kakhulu ebufakazini bemininingwane nezinqubo.
Isibonelo, inkampani eyenza imithi e-Europe ifuna ukungena emakethe yase-US ngomuthi wezinto ezingavuthiwe othembisayo futhi ithumele umkhiqizo oqinisekisiwe ku-US FDA. Ngaphambilini, phakathi nenqubo yokuhlanganiswa kwezinto ezingavuthiwe, kube nokuchezuka kokunemba kwelinye lamageji amabili okushisa ethangi lokusabela. Nakuba u-opharetha wayecubungule futhi wacela imiyalelo, abazange bayirekhode ngokuningiliziwe kumarekhodi eqoqo lokukhiqiza. Ngemuva kokukhiqizwa komkhiqizo, abahloli bekhwalithi bahlole kuphela ukungcola okwaziwayo ngesikhathi sokuhlaziywa kwe-chromatographic, futhi azikho izinkinga ezitholakele. Ngakho-ke, kwakhishwa umbiko wokuhlola ofanelekayo. Ngesikhathi sokuhlolwa, izikhulu ze-FDA zathola ukuthi ukunemba kwe-thermometer akuhlangabezani nezidingo, kodwa awekho amarekhodi ahambisanayo atholakele kumarekhodi eqoqo lokukhiqiza. Ngesikhathi sokuqinisekiswa kombiko wokuhlolwa kwekhwalithi, kutholwe ukuthi ukuhlaziywa kwe-chromatographic akwenziwanga ngokuya kwesikhathi esidingekayo. Konke lokhu kwephulwa kwe-cGMP akukwazi ukubalekela ukucutshungulwa kwe-censors, futhi lesi sidakamizwa ekugcineni sehlulekile ukungena emakethe yase-US.
I-FDA inqume ukuthi ukwehluleka kwayo ukuthobela imithetho ye-cGMP kuzolimaza impilo yabathengi baseMelika. Uma kukhona ukuchezuka ekunembeni ngokwezidingo ze-cGMP, uphenyo olwengeziwe kufanele luhlelwe, okuhlanganisa nokuhlola imiphumela engaba khona yokuchezuka kwezinga lokushisa ekunembeni, nokurekhoda ukuchezuka encazelweni yenqubo. Konke ukuhlolwa kwezidakamizwa okokungcola okwaziwayo nezinto ezimbi ezaziwayo kuphela, futhi ezingxenyeni ezingaziwa eziyingozi noma ezingahlobene, azikwazi ukutholwa ngokuphelele ngezindlela ezikhona.
Uma sihlola ikhwalithi yomuthi, sivamise ukusebenzisa indlela yokuhlola ikhwalithi ukuze sinqume ukuthi umuthi ufanelekile yini noma usekelwe ekusebenzeni kahle nokubukeka komkhiqizo. Nokho, ku-cGMP, umqondo wekhwalithi iyinkambiso yokuziphatha esebenza kuyo yonke inqubo yokukhiqiza. Umuthi ofaneleke ngokugcwele ungase ungahlangabezani nezidingo ze-cGMP, njengoba kunethuba lokuchezuka ohlelweni lwawo. Uma zingekho izimfuneko eziqinile zokulawula zenqubo yonke, izingozi ezingaba khona azikwazi ukutholwa ngemibiko yekhwalithi. Yingakho ukubulawa kwe-cGMP kungelula njengalokho.
Isikhathi sokuthumela: Jul-26-2023