Kuyini i-cGMP?
I-GMP yezidakamizwa yokuqala emhlabeni yazalelwa e-United States ngo-1963. Ngemva kokubuyekezwa okuningana kanye nokucebisa okuqhubekayo kanye nokuthuthukiswa yi-US FDA, i-cGMP (Current Good Manufacturing Practices) e-United States isibe ngomunye wabamele ubuchwepheshe obuthuthukisiwe emkhakheni we-GMP, idlala indima ebaluleke kakhulu ekusetshenzisweni okuphephile nokusebenzayo kwezidakamizwa emhlabeni jikelele. I-China yaqala ukumemezela i-GMP yezidakamizwa esemthethweni ngo-1988, futhi ikakhulukazi ibhekane nokubuyekezwa okuthathu kusukela ngo-1992, 1998, kanye no-2010, okusadinga ukuthuthukiswa okwengeziwe. Phakathi neminyaka engaphezu kwengu-20 yokukhuthaza umsebenzi we-GMP yezidakamizwa e-China, kusukela ekwethuleni umqondo we-GMP kuya ekukhuthazeni isitifiketi se-GMP, kufezwe impumelelo ngezigaba. Kodwa-ke, ngenxa yokuqala kwe-GMP sekwephuzile e-China, kube nezimpawu eziningi zokusebenzisa i-GMP ngomshini, futhi incazelo ye-GMP ayizange ihlanganiswe ngempela ekukhiqizweni kwangempela kanye nokuphathwa kwekhwalithi.
Ukuthuthukiswa kwe-cGMP
Izidingo zamanje ze-GMP eShayina zisese "esigabeni sokuqala" futhi ziyizidingo ezisemthethweni kuphela. Ukuze amabhizinisi aseShayina angene emakethe yamazwe ngamazwe ngemikhiqizo yawo, kumele avumelanise ukuphathwa kwawo kokukhiqiza nezindinganiso zamazwe ngamazwe ukuze athole ukuqashelwa emakethe. Nakuba uhulumeni waseShayina engakaqedi izinkampani zemithi ukuthi zisebenzise i-cGMP, lokhu akusho ukuthi akukho ukuphuthuma ngeShayina ukuthi isebenzise i-cGMP. Ngokuphambene nalokho, ukuphatha yonke inqubo yokukhiqiza ngokwezindinganiso ze-cGMP kuyimfuneko ebalulekile yokuqhubekela phambili ekuhlanganiseni amazwe ngamazwe. Ngenhlanhla, okwamanje eShayina, izinkampani zemithi ezinamasu okuthuthukisa abheke phambili ziye zaqaphela ukubaluleka kwesikhathi eside kwalomthethonqubo futhi zawusebenzisa.
Umlando Wokuthuthukiswa kwe-cGMP: I-cGMP eyamukelwa emhlabeni wonke, kungaba se-United States noma eYurophu, okwamanje ukuhlolwa kokuhambisana kwe-cGMP ezindaweni zokukhiqiza kulandela imininingwane ye-cGMP ehlanganisiwe yezinto zokusetshenziswa ezakhiwe yi-International Conference on Harmonization (ICH), eyaziwa nangokuthi i-ICH Q7A. Le ncazelo yavela kwi-International Conference on Harmonization of Raw Materials (ICH for API) eGeneva, eSwitzerland ngoSepthemba 1997. NgoMashi 1998, eholwa yi-US FDA, kwabhalwa "i-cGMP yezinto zokusetshenziswa ezihlanganisiwe", i-ICH Q7A. Ekwindla ka-1999, i-European Union kanye ne-United States bafinyelela esivumelwaneni sokuqashelwa kwe-cGMP kwezinto zokusetshenziswa ezihlanganisiwe. Ngemva kokuba isivumelwano siqale ukusebenza, zombili izinhlangothi zavumelana ngokuqaphela imiphumela yesitifiketi se-cGMP yomunye nomunye enqubweni yokuhweba ngezinto zokusetshenziswa ezihlanganisiwe. Ezinkampanini ze-API, imithethonqubo ye-cGMP empeleni iyizinto ezithile ze-ICH Q7A.
Umehluko phakathi kwe-cGMP ne-GMP
I-CGMP iyindinganiso ye-GMP esetshenziswa amazwe afana ne-United States, i-Europe, ne-Japan, eyaziwa nangokuthi "indinganiso ye-GMP yamazwe ngamazwe". Izindinganiso ze-cGMP azilingani nezindinganiso ze-GMP ezisetshenziswa eShayina.
Ukuqaliswa kwemithethonqubo ye-GMP eShayina kuyiqoqo lemithethonqubo ye-GMP esebenza emazweni asathuthuka aklanywe yi-WHO, kugxilwe kakhulu ezidingweni zehadiwe yokukhiqiza njengemishini yokukhiqiza.
I-cGMP esetshenziswa emazweni afana ne-United States, i-Europe, ne-Japan igxile ekukhiqizweni kwesofthiwe, njengokulawula izenzo zabaqhubi kanye nendlela yokusingatha izehlakalo ezingalindelekile enqubweni yokukhiqiza.
(1) Ukuqhathaniswa kwamakhathalogi okucaciswa kwesitifiketi. Ezicini ezintathu enqubweni yokukhiqiza izidakamizwa - izinhlelo zehadiwe, izinhlelo zesofthiwe, kanye nabasebenzi - i-cGMP e-United States ilula futhi inezahluko ezimbalwa kune-GMP e-China. Kodwa-ke, kunomehluko omkhulu ezidingweni ezingokwemvelo zalezi zinto ezintathu. I-GMP yase-China inezidingo eziningi zehadiwe, kuyilapho i-cGMP yase-United States inezidingo eziningi zesofthiwe nabasebenzi. Lokhu kungenxa yokuthi ikhwalithi yokukhiqiza yezidakamizwa incike kakhulu ekusebenzeni komqhubi, ngakho-ke indima yabasebenzi ekuphathweni kwe-GMP e-United States ibaluleke kakhulu kuneyemishini yasefektri.
(2) Ukuqhathaniswa kweziqu zomsebenzi. Ku-GMP yaseShayina, kunemithethonqubo eningiliziwe ngeziqu (izinga lemfundo) zabasebenzi, kodwa kunemingcele embalwa ngemithwalo yemfanelo yabasebenzi; Kuhlelo lwe-cGMP e-United States, iziqu (izinga lokuqeqeshwa) zabasebenzi zimfushane futhi zicacile, kanti imithwalo yemfanelo yabasebenzi inemininingwane eqinile. Lolu hlelo lomthwalo wemfanelo luqinisekisa kakhulu ikhwalithi yokukhiqizwa kwemithi.
(3) Ukuqhathaniswa kokuqoqwa kwamasampula nokuhlolwa. I-GMP yaseShayina ibeka kuphela izinqubo zokuhlola ezidingekayo, kuyilapho i-cGMP e-United States ibeka zonke izinyathelo zokuhlola nezindlela ngokuningiliziwe, inciphisa ukudideka nokungcoliswa kwemithi ezigabeni ezahlukene, ikakhulukazi esigabeni sezinto zokusetshenziswa, futhi inikeze isiqinisekiso sokuthuthukisa ikhwalithi yemithi evela emthonjeni.
Ubunzima ekusebenziseni i-cGMP
Ukuguqulwa kwe-GMP kwamabhizinisi emithi aseShayina kube lula kakhulu. Kodwa-ke, kusenezinselele ekusebenziseni i-cGMP, ikakhulukazi ezibonakala ngobuqiniso bemininingwane nezinqubo.
Isibonelo, inkampani yemithi eYurophu ifuna ukungena emakethe yase-US nomuthi wezinto zokusetshenziswa othembisayo futhi ithumele umkhiqizo oqinisekisiwe kwi-FDA yase-US. Ngaphambilini, ngesikhathi senqubo yokwenziwa kwezinto zokusetshenziswa, kwakukhona ukuphambuka kokunemba kwenye yezikali ezimbili zokushisa zethangi lokusabela. Nakuba umqhubi wayecubungule futhi wacela imiyalelo, abazange bayibhale ngokuningiliziwe kumarekhodi eqoqo lokukhiqiza. Ngemva kokuba umkhiqizo ukhiqizwe, abahloli bekhwalithi bahlole kuphela ukungcola okwaziwayo ngesikhathi sokuhlaziywa kwe-chromatographic, futhi akukho zinkinga ezitholakele. Ngakho-ke, kwakhishwa umbiko wokuhlola ofanelekile. Ngesikhathi sokuhlolwa, izikhulu ze-FDA zithole ukuthi ukunemba kwe-thermometer akuhlangabezani nezidingo, kodwa akukho marekhodi ahambisanayo atholakale kumarekhodi eqoqo lokukhiqiza. Ngesikhathi sokuqinisekiswa kombiko wokuhlolwa kwekhwalithi, kwatholakala ukuthi ukuhlaziywa kwe-chromatographic akwenziwanga ngokwesikhathi esidingekayo. Konke lokhu kwephulwa kwe-cGMP akunakuphunyuka ekuhlolweni kwabahloli, futhi lo muthi ekugcineni wehluleka ukungena emakethe yase-US.
I-FDA inqume ukuthi ukwehluleka kwayo ukuthobela imithetho ye-cGMP kuzolimaza impilo yabathengi baseMelika. Uma kukhona ukuphambuka ekunembeni ngokwezidingo ze-cGMP, kufanele kuhlelwe uphenyo olwengeziwe, okuhlanganisa nokuhlola imiphumela engaba khona yokuphambuka ekunembeni kwezinga lokushisa, nokurekhoda ukuphambuka encazelweni yenqubo. Konke ukuhlolwa kwemithi kwenzelwa ukungcola okwaziwayo kanye nezinto eziyingozi ezaziwayo, kanye nezingxenye ezingaziwa eziyingozi noma ezingahlobene, azikwazi ukutholwa ngokuphelele ngezindlela ezikhona.
Uma sihlola ikhwalithi yomuthi, sivame ukusebenzisa izindlela zokuhlola ikhwalithi ukuze sinqume ukuthi umuthi uyafaneleka yini noma ngokusekelwe ekusebenzeni kahle nasekubukekeni komkhiqizo. Kodwa-ke, ku-cGMP, umqondo wekhwalithi uyindlela yokuziphatha eqhubeka kuyo yonke inqubo yokukhiqiza. Umuthi ofaneleka ngokugcwele ungase ungahlangabezani nezidingo ze-cGMP, njengoba kungenzeka ukuthi kukhona ukuphambuka enkambisweni yawo. Uma kungekho zidingo eziqinile zomthetho zenqubo yonke, izingozi ezingaba khona azikwazi ukutholakala ngemibiko yekhwalithi. Yingakho ukwenziwa kwe-cGMP kungelula kanjalo.
Isikhathi sokuthunyelwe: Julayi-26-2023