Kodi cGMP ndi chiyani?
Mankhwala oyamba padziko lonse a GMP adabadwa ku United States mu 1963. Pambuyo pa kusintha kangapo ndi kupititsa patsogolo ndi kusintha kosalekeza kwa FDA ku US, cGMP (Current Good Manufacturing Practices) ku United States yakhala imodzi mwa oimira ukadaulo wapamwamba mu gawo la GMP, ikuchita gawo lofunika kwambiri pakugwiritsa ntchito mankhwala motetezeka komanso moyenera padziko lonse lapansi. China idalengeza koyamba za mankhwala a GMP mu 1988, ndipo yasinthidwa katatu kuyambira 1992, 1998, ndi 2010, zomwe zikufunikabe kukonzedwanso. Pazaka zoposa 20 zolimbikitsa ntchito ya mankhwala a GMP ku China, kuyambira kuyambitsa lingaliro la GMP mpaka kulimbikitsa satifiketi ya GMP, zinthu zachitika pang'onopang'ono. Komabe, chifukwa cha kuyamba mochedwa kwa GMP ku China, pakhala zochitika zambiri zogwiritsa ntchito GMP mwaukadaulo, ndipo tanthauzo la GMP silinaphatikizidwe kwenikweni mu kupanga kwenikweni ndi kasamalidwe kabwino.
Kukula kwa cGMP
Zofunikira za GMP zomwe zilipo ku China zidakali "gawo loyamba" ndipo ndi zofunikira zovomerezeka zokha. Kuti mabizinesi aku China alowe mumsika wapadziko lonse lapansi ndi zinthu zawo, ayenera kugwirizanitsa kayendetsedwe kawo kopanga ndi miyezo yapadziko lonse lapansi kuti apeze kudziwika pamsika. Ngakhale boma la China silinalamulire makampani opanga mankhwala kuti agwiritse ntchito cGMP, izi sizikutanthauza kuti palibe kufunikira kwa China kukhazikitsa cGMP. M'malo mwake, kuyang'anira njira yonse yopangira malinga ndi miyezo ya cGMP ndikofunikira kwambiri kuti apite kudziko lonse lapansi. Mwamwayi, pakadali pano ku China, makampani opanga mankhwala omwe ali ndi njira zotsogola zopititsira patsogolo azindikira kufunika kwa nthawi yayitali kwa lamuloli ndikuligwiritsa ntchito.
Mbiri ya Kukula kwa cGMP: CGMP yovomerezeka padziko lonse lapansi, kaya ku United States kapena ku Europe, pakadali pano kuwunika kotsatira malamulo a cGMP pamalo opangira kumatsatira zomwe cGMP yogwirizana ya zinthu 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 Seputembala 1997. Mu Marichi 1998, motsogozedwa ndi US FDA, "cGMP yogwirizana ya zinthu zopangira," ICH Q7A, idalembedwa. M'dzinja la 1999, European Union ndi United States adafika pa mgwirizano wovomerezana wa cGMP wa zinthu zopangira. Mgwirizanowu utayamba kugwira ntchito, magulu onse awiri adagwirizana kuti azindikire zotsatira za cGMP za wina ndi mnzake mu njira yogulitsira zinthu zopangira. Kwa makampani a API, malamulo a cGMP kwenikweni ndi omwe ali mu ICH Q7A.
Kusiyana pakati pa cGMP ndi GMP
CGMP ndi muyezo wa GMP womwe umayendetsedwa ndi mayiko monga United States, Europe, ndi Japan, omwe amadziwikanso kuti "muyezo wapadziko lonse wa GMP". Miyezo ya cGMP si yofanana ndi miyezo ya GMP yomwe imayendetsedwa ku China.
Kukhazikitsidwa kwa malamulo a GMP ku China ndi mndandanda wa malamulo a GMP omwe amagwiritsidwa ntchito kumayiko osatukuka omwe adapangidwa ndi WHO, makamaka pazofunikira pa zida zopangira monga zida zopangira.
CGMP yomwe ikugwiritsidwa ntchito m'maiko monga United States, Europe, ndi Japan imayang'ana kwambiri pakupanga mapulogalamu, monga kuwongolera zochita za ogwiritsa ntchito komanso momwe angachitire ndi zochitika zosayembekezereka pakupanga.
(1) Kuyerekeza makatalogu a satifiketi. Pazinthu zitatu zomwe zimapanga mankhwala - makina a hardware, mapulogalamu, ndi antchito - cGMP ku United States ndi yosavuta ndipo ili ndi mitu yochepa kuposa GMP ku China. Komabe, pali kusiyana kwakukulu pa zofunikira za zinthu zitatuzi. GMP yaku China ili ndi zofunikira zambiri pa hardware, pomwe cGMP yaku United States ili ndi zofunikira zambiri pa mapulogalamu ndi antchito. Izi zili choncho chifukwa mtundu wa mankhwala opangidwa umadalira kwambiri momwe wogwiritsa ntchito amagwirira ntchito, kotero udindo wa ogwira ntchito pa kasamalidwe ka GMP ku United States ndi wofunika kwambiri kuposa wa zida zamafakitale.
(2) Kuyerekeza ziyeneretso za ntchito. Mu GMP ya ku China, pali malamulo atsatanetsatane okhudza ziyeneretso (mlingo wamaphunziro) wa ogwira ntchito, koma pali zoletsa zochepa pa maudindo a ogwira ntchito; Mu dongosolo la cGMP ku United States, ziyeneretso (mlingo wa maphunziro) za ogwira ntchito ndi zazifupi komanso zomveka bwino, pomwe maudindo a ogwira ntchito ndi ofotokozedwa mwatsatanetsatane. Dongosolo la udindo limeneli limatsimikizira kwambiri kuti mankhwala apangidwa bwino.
(3) Kuyerekeza kusonkhanitsa ndi kuyang'anira zitsanzo. GMP ya ku China imangofotokoza njira zofunikira zowunikira, pomwe cGMP ku United States imafotokoza njira zonse zowunikira mwatsatanetsatane, kuchepetsa chisokonezo ndi kuipitsidwa kwa mankhwala pazigawo zosiyanasiyana, makamaka pagawo la zopangira, ndikupereka chitsimikizo cha kusintha kwa khalidwe la mankhwala kuchokera ku gwero.
Mavuto pakukhazikitsa cGMP
Kusintha kwa GMP kwa makampani opanga mankhwala aku China kwakhala kosalala. Komabe, pali zovuta pakukhazikitsa cGMP, makamaka zomwe zimawonekera pakutsimikizika kwa tsatanetsatane ndi njira.
Mwachitsanzo, kampani ina ya mankhwala ku Europe ikufuna kulowa mumsika wa US ndi mankhwala odalirika a zinthu zopangira ndipo ipereka mankhwala ovomerezeka ku US FDA. Kale, panthawi yopanga zinthu zopangira, panali kupotoka kolondola mu imodzi mwa njira ziwiri zoyezera kutentha kwa thanki yoyankhira. Ngakhale kuti wogwiritsa ntchitoyo adakonza ndikupempha malangizo, sanawalembe mwatsatanetsatane pa zolemba za gulu lopanga. Pambuyo poti chinthucho chapangidwa, oyang'anira khalidwe ankangoyang'ana zinyalala zodziwika panthawi yosanthula chromatographic, ndipo palibe vuto lomwe linapezeka. Chifukwa chake, lipoti loyenerera lowunikira linaperekedwa. Pakuwunika, akuluakulu a FDA adapeza kuti kulondola kwa thermometer sikunakwaniritse zofunikira, koma palibe zolemba zofanana zomwe zinapezeka mu zolemba za gulu lopanga. Pakutsimikizira lipoti lowunikira khalidwe, zidapezeka kuti kusanthula kwa chromatographic sikunachitike malinga ndi nthawi yofunikira. Kuphwanya konseku kwa cGMP sikungathe kuthawa kuyang'aniridwa ndi owunikira, ndipo mankhwalawa pamapeto pake adalephera kulowa mumsika wa US.
FDA yatsimikiza kuti kulephera kwake kutsatira malamulo a cGMP kungawononge thanzi la ogula aku America. Ngati pali kupotoka kolondola malinga ndi zofunikira za cGMP, kafukufuku wina ayenera kukonzedwa, kuphatikizapo kuwona zotsatira zomwe zingatheke chifukwa cha kupotoka kolondola kwa kutentha, ndikulemba kupotoka kuchokera ku kufotokozera kwa njira. Kuwunika konse kwa mankhwala ndi kokha kwa zinyalala zodziwika ndi zinthu zoyipa zodziwika, ndipo pazinthu zosadziwika zowopsa kapena zosagwirizana, sizingadziwike mokwanira kudzera m'njira zomwe zilipo.
Poyesa ubwino wa mankhwala, nthawi zambiri timagwiritsa ntchito njira zowunikira ubwino kuti tidziwe ngati mankhwalawo ndi oyenerera kapena kutengera momwe mankhwalawo alili komanso momwe akuonekera. Komabe, mu cGMP, lingaliro la ubwino ndi khalidwe lomwe limagwira ntchito nthawi yonse yopanga. Mankhwala oyenerera mokwanira sangakwaniritse zofunikira za cGMP, chifukwa pali kuthekera kosintha njira yake. Ngati palibe zofunikira zokhwima pa malamulo a ndondomeko yonse, zoopsa zomwe zingachitike sizingadziwike ndi malipoti abwino. Ichi ndichifukwa chake kugwiritsa ntchito cGMP sikophweka choncho.
Nthawi yotumizira: Julayi-26-2023