Uyazi ukuthi iyini i-CGMP?

Yini i-CGMP?

Izidakamizwa zakuqala emhlabeni zazalelwa e-United States ngo-1963. Ngemuva kokubuyekezwa okuningana kanye nokucebisa okuqhubekayo kanye nokwenza ngcono okwenziwa yi-US FDA, CGMP (imikhuba yamanje yokukhiqiza okuhle) e-United States sekube ngomunye wabamele ubuchwepheshe obuthuthukisiwe ku-GMP Inkambu, idlala indima ebaluleke kakhulu ekusebenziseni izidakamizwa eziphephile nangokuphumelelayo emhlabeni jikelele. I-China yaqala ukuklembukisa i-GMP yezidakamizwa esemthethweni ngo-1988, futhi ibisalokhu yathuthukiswa kathathu kusukela ngo-1992, 1998, no-2010, okusadinga ukuthuthuka okwengeziwe. Eminyakeni engaphezu kwengu-20 yokukhuthaza ukusebenza kwezidakamizwa kwe-GMP eChina, kusuka ekungeniseni umqondo we-GMP ukukhuthaza ukuqinisekiswa kwe-GMP, impumelelo ebekiwe itholiwe. Kodwa-ke, ngenxa yokuqalwa sekwedlule isikhathi kwe-GMP eChina, kube nezimo eziningi zokwenza izinto ze-GMP ngezisebenzi, futhi okushiwo i-GMP akukaze kuhlanganiswe ngempela ekukhiqizweni kwangempela kanye nokuphathwa kwekhwalithi.

 

Ukuthuthukiswa kwe-CGMP

Izidingo zamanje ze-GMP eChina zisesiteji sokuqala "futhi ziyizidingo ezihlelekile kuphela. Ukuze amabhizinisi aseChinese angene emakethe yamazwe omhlaba nemikhiqizo yawo, kufanele avumelane nabaphathi babo bokukhiqiza namazinga aphesheya ukuze athole ukuqashelwa kwemakethe. Yize uhulumeni waseChina engakabi namanje izinkampani ezenza imithi ukuze asebenzise i-CGMP, lokhu akusho ukuthi akunakuphuthuma kweChina ukuba kusebenze i-CGMP. Ngokuphambene nalokho, ukuphatha yonke inqubo yokukhiqiza ngokusho kwamazinga we-CGMP kuyinto yokuqala ebalulekile yokuqhubekela phambili ekuhambeni kwamazwe omhlaba. Ngenhlanhla, njengamanje eChina, izinkampani ezenza imithi ezinamasu okuthuthukisa abheke phambili selibonile ukubaluleka kwesikhathi eside kwalo mthethonqubo futhi kwasisebenzisa.

Umlando wokuthuthukiswa kwe-CGMP: I-CGMP eyamukelwa emhlabeni jikelele, kungaba e-United States noma eYurophu, njengamanje Ukuhlolwa kokutholwa kwe-CGMP ezindaweni zokukhiqiza kulandela ukucaciswa kwengqungquthela ye-CGMP okuhlangene (ich), eyaziwa nangokuthi i-Ich Q7A . Lokhu kucaciswa okuvela engqungqutheleni yamazwe omhlaba ngokuvumelanisa kwezinto zokwenziwa (ich for api) eGeneva, eSwitzerland ngoSepthemba 1997, i-CGMP ye-US FDA, i-ICH Q7A, yabhalwa. Ekwindla ka-1999, i-European Union kanye ne-United States yafika esivumelwaneni sokuqashelwa kwe-CGMP uqobo sezinto ezisetshenziswayo. Ngemuva kokuthi lesi sivumelwano siqale ukusebenza, zombili lezi zinhlaka zivumile ukubona ukuthi isitifiketi se-CGMP se-CGMP siphumela kwinqubo yokuhweba yezinto zokusetshenziswa. Izinkampani ze-API, imithetho ye-CGMP empeleni ngokuqukethwe okuthile kwe-Ich Q7A.

 

Umehluko phakathi kwe-CGMP ne-GMP

I-CGMP iyindlela ejwayelekile ye-GMP esetshenzisiwe yi-United States, eYurophu naseJapan, eyaziwa nangokuthi "International GMP Standard". Amazinga we-CGMP awafani namazinga we-GMP asetshenziswe eChina.

Ukuqaliswa kwemithetho ye-GMP ye-China kusethi yemithethonqubo ye-GMP esebenza emazweni asathuthuka akhiwe yi-WHO, ngokugcizelela okuthile kwizidingo zokukhiqiza.

I-CGMP iyenziwa emazweni afana ne-United States, i-Europe, neJapan igxile ekukhiqizweni kwesoftware, njengokulawula izenzo zabasebenza kanye nendlela yokuphatha imicimbi engalindelekile kwinqubo yokukhiqiza.

(1) Ukuqhathaniswa kwezinhlu zokucaciswa kwesitifiketi. Kulezi zinto ezintathu kwinqubo yokukhiqiza izidakamizwa - amasistimu we-Hardware, amasistimu wesoftware, kanye nabasebenzi - I-CGMP e-United States ilula futhi inezihluko ezimbalwa kune-GMP eChina. Kodwa-ke, kunomehluko obalulekile kwizidingo ezingokwemvelo zalezi zinto ezintathu. I-GMP yaseChina inezidingo eziningi ze-Hardware, ngenkathi i-United States 'CGMP inezidingo eziningi zesoftware kanye nabasebenzi. Lokhu kungenxa yokuthi ikhwalithi yokukhiqiza yezidakamizwa ngokuyisisekelo incike ekusebenzeni komhlinzeki, ngakho-ke indima yabasebenzi ekuphathweni kwe-GMP e-United States ibaluleke kakhulu kunaleyo mishini yefektri.

(2) Ukuqhathaniswa kweziqu zomsebenzi. E-GMP yaseChina, kunemithetho enemininingwane yeziqu (izinga lemfundo) labasebenzi, kepha zimbalwa izingqinamba kwizibopho zabasebenzi; Ohlelweni lwe-CGMP e-United States, izimfanelo (izinga lokuqeqeshwa) lwabasebenzi lifushane futhi licacile, kanti izibopho zabasebenzi zinemininingwane enemininingwane. Lolu hlelo lokuzibophezela luqinisekisa ikhwalithi yokukhiqiza yezidakamizwa.

(3) Ukuqhathanisa iqoqo lesampula nokuhlola. I-GMP yaseChina ibeka kuphela izinqubo zokuhlola ezidingekayo, kanti i-CGMP e-United States icacisa zonke izinyathelo zokuhlola nezindlela ngemininingwane ebonakalayo, ikakhulukazi ekungcolisweni kwezidakamizwa ezibonakalayo, ikakhulukazi ekuqinisekiseni ikhwalithi yezidakamizwa kusuka umthombo.

 

Ubunzima ekusebenziseni i-CGMP

Ukuguqulwa kwe-GMP yamabhizinisi amakhambi amaShayina bekubushelelezi. Kodwa-ke, kusenezinselelo ekusebenziseni i-CGMP, ikakhulukazi eboniswa ubuqiniso bemininingwane nezinqubo.

Isibonelo, inkampani yezemithi eYurophu ifuna ukungena emakethe yase-US ngethembisa izidakamizwa ezibonakalayo ezibonakalayo futhi ihambisa umkhiqizo oqinisekisiwe e-US FDA. Phambilini, ngesikhathi senqubo yokuhlanganiswa impahla eluhlaza, kwaba nokuphambuka kokunemba kokunye kokushisa okukodwa kwamazinga okushisa ethangi lokuphendula. Yize opharetha esetshenzwe futhi wacela imiyalo, azange ayiqophe ngokuningiliziwe kumarekhodi ama-batch akhiqizayo. Ngemuva kokuthi umkhiqizo ukhiqizwe, abahloli bekhwalithi bahlolwe kuphela ukungcola okwaziwayo ngesikhathi sokuhlaziywa kwe-chromatographic, futhi azikho izinkinga ezitholakele. Ngakho-ke, kukhishwe umbiko wokuhlola ofanelekayo. Ngesikhathi sokuhlola, izikhulu ze-FDA zithole ukuthi ukunemba kwe-thermometer akuzange kuhlangabezane nezidingo, kepha awekho amarekhodi ahambisanayo atholakala kumarekhodi okukhiqiza ama-batch. Ngesikhathi sokuqinisekiswa kombiko wokuhlola wekhwalithi, kwatholakala ukuthi ukuhlaziywa kwe-chromatographic bekungenziwanga ngokuya ngesikhathi esidingekayo. Konke lokhu ukwephulwa kwe-CGMP ngeke kuphunyule ekuhlolweni kwabacwasi, futhi lo muthi wehlulekile ukungena emakethe yase-US.

I-FDA inqume ukuthi ukwehluleka kwayo ukuhambisana nemithetho ye-CGMP kuzolimaza impilo yabathengi baseMelika. Uma kunokuphambuka ngokunemba ngokuya ngezidingo ze-CGMP, kufanele kuhlelwe ezinye izidingo, kufaka phakathi ukubheka imiphumela yokushisa yokushisa ngokunemba, nokuqopha ukuphambuka encazelweni yenqubo. Konke ukuhlolwa kwezidakamizwa kumane kungcoliswa okwaziwayo kanye nezinto ezimbi ezaziwayo, kanye nezakhi eziyingozi ezingaziwa noma ezingahlobene, azikwazi ukutholwa ngokuphelele ngezindlela ezikhona.

Lapho sihlola ikhwalithi yesidakamizwa, sivame ukusebenzisa izindlela zokuhlola ezisezingeni elifanele ukuthola ukuthi umuthi ufanelekile noma ususelwa ekusebenzeni kahle nasekubukekeni komkhiqizo. Kodwa-ke, ku-CGMP, umqondo wekhwalithi ejwayelekile yokuziphatha egijima kuyo yonke inqubo yokukhiqiza. Umuthi ofaneleka ngokuphelele kungenzeka angahlangabezani nezidingo ze-CGMP, ngoba kungenzeka ukuthi kungenzeka ukuphambuka kwinqubo yawo. Uma kungekho zidingo eziqinile zokulawula zenqubo yonke, izingozi ezingaba khona azikwazi ukutholwa ngemibiko yekhwalithi. Lokhu yingakho ukwenziwa kwe-CGMP kungelula njengalokho.