Kodi cGMP ndi chiyani?
Mankhwala oyambirira padziko lonse GMP anabadwira ku United States mu 1963. Pambuyo pa kusinthidwa kangapo ndikulemeretsa kosalekeza ndi US FDA, cGMP (Current Good Manufacturing Practices) ku United States wakhala mmodzi mwa oimira luso lamakono mu GMP. field, yomwe ikugwira ntchito yofunika kwambiri pakugwiritsa ntchito bwino mankhwala osokoneza bongo padziko lonse lapansi.China idalengeza koyamba za GMP yovomerezeka mu 1988, ndipo idasinthidwa katatu kuyambira 1992, 1998, ndi 2010, zomwe zikufunikabe kuwongolera.Pazaka zopitilira 20 zolimbikitsa ntchito ya GMP ya mankhwala ku China, kuyambira poyambitsa lingaliro la GMP mpaka kupititsa patsogolo chiphaso cha GMP, zopambana zakwaniritsidwa.Komabe, chifukwa chakuchedwa kuyambika kwa GMP ku China, pakhala zochitika zambiri zogwiritsa ntchito GMP mwamakina, ndipo tanthauzo la GMP silinaphatikizidwe kwenikweni pakupanga ndi kasamalidwe kabwino.
Kukula kwa cGMP
Zofunikira pakalipano za GMP ku China zikadali mu "gawo loyambirira" ndipo ndizofunikira zokhazokha.Kuti mabizinesi aku China alowe mumsika wapadziko lonse ndi zinthu zawo, akuyenera kugwirizanitsa kasamalidwe kawo kakupanga ndi miyezo yapadziko lonse lapansi kuti azindikirike pamsika.Ngakhale kuti boma la China silinapatsebe mphamvu makampani opanga mankhwala kuti agwiritse ntchito cGMP, izi sizikutanthauza kuti palibe changu kuti China igwiritse ntchito cGMP.M'malo mwake, kuyang'anira ntchito yonse yopanga molingana ndi mfundo za cGMP ndikofunikira kuti mupite kumayiko ena.Mwamwayi, pakali pano ku China, makampani opanga mankhwala omwe ali ndi njira zachitukuko zamtsogolo azindikira kufunikira kwa nthawi yayitali kwa lamuloli ndikuligwiritsa ntchito.
Mbiri Yachitukuko cha cGMP: CGMP yovomerezeka padziko lonse lapansi, kaya ku United States kapena ku Europe, pakali pano kuwunika kwa cGMP kumatsata malo opangira zinthu kumatsatira mfundo zolumikizana za cGMP zazinthu zopangira zopangidwa ndi International Conference on Harmonization (ICH), yomwe imadziwikanso kuti ICH Q7A. .Izi zinachokera ku International Conference on Harmonization of Raw Materials (ICH for API) ku Geneva, Switzerland mu September 1997. Mu March 1998, motsogoleredwa ndi US FDA, "cGMP for raw materials" yogwirizana, ICH Q7A, inalembedwa.M'dzinja la 1999, European Union ndi United States adagwirizana mgwirizano wogwirizana wa cGMP pazinthu zopangira.Mgwirizanowu utayamba kugwira ntchito, onse awiri adagwirizana kuti azindikire zotsatira za certification ya cGMP pakupanga malonda azinthu zopangira.Kwa makampani a API, malamulo a cGMP ndizomwe zili mu ICH Q7A.
Kusiyana pakati pa cGMP ndi GMP
CGMP ndi mulingo wa GMP wokhazikitsidwa ndi mayiko monga United States, Europe, ndi Japan, womwe umadziwikanso kuti "international GMP standard".Miyezo ya cGMP siyofanana ndi miyezo ya GMP yomwe imakhazikitsidwa ku China.
Kukhazikitsa malamulo a GMP ku China ndi malamulo a GMP omwe amagwiritsidwa ntchito kumayiko omwe akutukuka kumene opangidwa ndi WHO, ndikugogomezera kwambiri zofunikira pakupanga zida monga zida zopangira.
CGMP yomwe idakhazikitsidwa m'maiko monga United States, Europe, ndi Japan imayang'ana kwambiri kupanga mapulogalamu, monga kuwongolera zochita za ogwiritsa ntchito komanso momwe angachitire ndi zochitika zosayembekezereka popanga.
(1) Kuyerekeza kwamakatalo a certification.Pazinthu zitatu zomwe zimagwiritsidwa ntchito popanga mankhwala - machitidwe a hardware, mapulogalamu a mapulogalamu, ndi ogwira ntchito - cGMP ku United States ndi yosavuta ndipo ili ndi mitu yochepa kusiyana ndi GMP ku China.Komabe, pali kusiyana kwakukulu muzofunikira zachibadwa za zinthu zitatuzi.GMP yaku China ili ndi zofunikira zambiri pa Hardware, pomwe cGMP yaku United States ili ndi zofunikira zambiri pamapulogalamu ndi antchito.Izi zili choncho chifukwa kapangidwe ka mankhwala kumadalira momwe wogwiritsira ntchito amagwirira ntchito, choncho udindo wa ogwira ntchito pa kayendetsedwe ka GMP ku United States ndi wofunika kwambiri kuposa zida za fakitale.
(2) Kuyerekezera ziyeneretso za ntchito.Mu GMP ya ku China, pali malamulo atsatanetsatane okhudza ziyeneretso (maphunziro a maphunziro) a ogwira ntchito, koma pali zopinga zochepa pa maudindo a ogwira ntchito;Mu dongosolo la cGMP ku United States, ziyeneretso (zophunzitsidwa) za ogwira ntchito ndizofupikitsa komanso zomveka bwino, pamene udindo wa ogwira ntchito ndi wofotokozedwa mwatsatanetsatane.Dongosolo laudindoli limatsimikizira kupangidwa kwa mankhwala.
(3) Kuyerekeza kusonkhanitsa zitsanzo ndi kuyendera.GMP ya ku China imangonena njira zoyenera zoyendera, pomwe cGMP ku United States imafotokoza njira zonse zowunikira mwatsatanetsatane, kuchepetsa chisokonezo ndi kuipitsidwa kwa mankhwala pazigawo zosiyanasiyana, makamaka pazida zopangira, komanso kupereka chitsimikizo pakuwongolera mankhwalawo gwero.
Zovuta pakukhazikitsa cGMP
Kusintha kwa GMP kwa mabizinesi aku China aku China kwakhala kosavuta.Komabe, pali zovuta pakugwiritsa ntchito cGMP, zomwe zikuwonetsedwa makamaka pakutsimikizika kwatsatanetsatane ndi njira.
Mwachitsanzo, kampani yopanga mankhwala ku Europe ikufuna kulowa mumsika waku US ndi mankhwala odalirika ndikutumiza mankhwala ovomerezeka ku US FDA.Poyamba, pa zopangira kaphatikizidwe ndondomeko, panali zolondola kupatuka mmodzi wa awiri kutentha gauges anachita thanki.Ngakhale kuti wogwiritsa ntchitoyo adakonza ndikupempha malangizo, sanalembe mwatsatanetsatane pamabuku opangira.Zogulitsazo zitapangidwa, oyang'anira apamwamba amangoyang'ana zonyansa zodziwika pakuwunika kwa chromatographic, ndipo palibe zovuta zomwe zidapezeka.Choncho, lipoti loyendera loyenerera linaperekedwa.Pakuwunika, akuluakulu a FDA adapeza kuti kulondola kwa thermometer sikunakwaniritse zofunikira, koma palibe zolemba zofananira zomwe zidapezeka m'mabuku opangira.Pakutsimikizira lipoti loyendera bwino, zidapezeka kuti kusanthula kwa chromatographic sikunachitike molingana ndi nthawi yofunikira.Kuphwanya konseku kwa cGMP sikungathe kuthawa kuwunika kwa ma censors, ndipo mankhwalawa adalephera kulowa mumsika waku US.
A FDA atsimikiza kuti kulephera kwake kutsatira malamulo a cGMP kungawononge thanzi la ogula aku America.Ngati pali kupatuka kolondola molingana ndi zofunikira za cGMP, kufufuza kwina kuyenera kukonzedwa, kuphatikizapo kuyang'ana zotsatira zomwe zingatheke za kutentha kwa kutentha kuchokera ku kulondola, ndi kujambula kupatuka kwa ndondomeko ya ndondomeko.Kuwunika konse kwa mankhwala kumangotengera zonyansa zodziwika bwino ndi zinthu zoyipa zomwe zimadziwika bwino, komanso pazinthu zovulaza kapena zosagwirizana nazo, sizingadziwike momveka bwino kudzera munjira zomwe zilipo.
Poyesa ubwino wa mankhwala, nthawi zambiri timagwiritsa ntchito njira zowunikira kuti tiwone ngati mankhwalawa ali oyenerera kapena kutengera mphamvu ndi maonekedwe a mankhwalawo.Komabe, mu cGMP, lingaliro laubwino ndi chikhalidwe chomwe chimayendera nthawi yonse yopanga.Mankhwala oyenerera bwino sangakwaniritse zofunikira za cGMP, chifukwa pali mwayi wopatuka munjira yake.Ngati palibe malamulo okhwima pa ndondomeko yonseyi, zoopsa zomwe zingakhalepo sizingadziwike ndi malipoti abwino.Ichi ndichifukwa chake kuphedwa kwa cGMP sikuli kophweka monga choncho.
Nthawi yotumiza: Jul-26-2023