UYAZI NGABA YINTONI I-cGMP?

Yintoni i-cGMP?

I-GMP yokuqala yamayeza ehlabathini yazalwa eMelika ngo-1963. Emva kokuhlaziywa okuphindaphindiweyo kunye nokuphucuka okuqhubekayo yi-FDA yase-US, i-cGMP (Current Good Manufacturing Practices) eMelika iye yaba ngomnye wabameli betekhnoloji ephucukileyo kwicandelo le-GMP, idlala indima ebaluleke ngakumbi ekusetyenzisweni ngokukhuselekileyo nangokusebenzayo kwamayeza kwihlabathi liphela. I-China yaqala ukupapasha i-GMP yamayeza esemthethweni ngo-1988, kwaye ikakhulu iye yahlaziywa kathathu ukusukela ngo-1992, 1998, kunye no-2010, okusafuna ukuphuculwa ngakumbi. Kwiminyaka engaphezu kwama-20 yokukhuthaza umsebenzi we-GMP yamayeza eTshayina, ukususela ekuqaliseni ingcamango ye-GMP ukuya ekukhuthazeni isiqinisekiso se-GMP, kuye kwafezekiswa impumelelo ngezigaba. Nangona kunjalo, ngenxa yokuqala kade kwe-GMP eTshayina, kubekho izinto ezininzi zokusetyenziswa kwe-GMP ngoomatshini, kwaye intsingiselo ye-GMP ayifakwanga ngokwenene kwimveliso yokwenyani kunye nolawulo lomgangatho.

 

Uphuhliso lwe-cGMP

Iimfuneko ze-GMP zangoku eTshayina zisekwi "sigaba sokuqala" kwaye ziimfuno ezisemthethweni kuphela. Ukuze amashishini aseTshayina angene kwimarike yamazwe ngamazwe ngeemveliso zawo, kufuneka alungelelanise ulawulo lwawo lwemveliso nemigangatho yamazwe ngamazwe ukuze afumane ukuqatshelwa kwimarike. Nangona urhulumente waseTshayina engakagunyazisi iinkampani zamayeza ukuba zisebenzise i-cGMP, oku akuthethi ukuba akukho ngxamiseko yokuba iTshayina isebenzise i-cGMP. Ngokwahlukileyo koko, ukulawula yonke inkqubo yemveliso ngokwemigangatho ye-cGMP kuyimfuneko ebalulekileyo yokuqhubela phambili ukuya kwihlabathi liphela. Ngethamsanqa, okwangoku eTshayina, iinkampani zamayeza ezinezicwangciso zophuhliso ezijonge phambili ziye zaqonda ukubaluleka kwexesha elide kwalo mthetho kwaye zawusebenzisa.

Imbali yoPhuhliso lwe-cGMP: I-cGMP eyamkelweyo kwihlabathi liphela, nokuba iseMelika okanye eYurophu, okwangoku ukuhlolwa kokuthobela i-cGMP kwiindawo zemveliso kulandela iinkcukacha ze-cGMP ezihlanganisiweyo zezinto eziluhlaza ezenziwe yiNkomfa yeHlabathi yoKuvumelana (ICH), eyaziwa ngokuba yi-ICH Q7A. Le nkcazo ivela kwiNkomfa yeHlabathi yoKuvumelana kwezinto eziluhlaza (ICH for API) eGeneva, eSwitzerland ngoSeptemba 1997. NgoMatshi 1998, ikhokelwa yi-US FDA, kwabhalwa "i-cGMP yezinto eziluhlaza", i-ICH Q7A. Ekwindla ka-1999, i-European Union kunye ne-United States bafikelela kwisivumelwano sokuqatshelwa kwe-cGMP kwizinto eziluhlaza. Emva kokuba isivumelwano siqalile ukusebenza, omabini amaqela avumile ukwamkela iziphumo zesatifikethi se-cGMP somnye nomnye kwinkqubo yorhwebo lwezinto eziluhlaza. Kwiinkampani ze-API, imigaqo ye-cGMP ngokwenene ngumxholo othile we-ICH Q7A.

 

Umahluko phakathi kwe-cGMP kunye ne-GMP

I-CGMP ngumgangatho we-GMP osetyenziswa ngamazwe afana ne-United States, iYurophu, neJapan, akwabizwa ngokuba "ngumgangatho we-GMP wamazwe ngamazwe". Imigangatho ye-cGMP ayilingani nemigangatho ye-GMP esetyenziswa eTshayina.

Ukuphunyezwa kwemigaqo ye-GMP eTshayina yiseti yemigaqo ye-GMP esebenza kumazwe asaphuhlayo eyenziwe yi-WHO, igxininisa ngakumbi kwiimfuno zezixhobo zemveliso ezifana nezixhobo zemveliso.

I-cGMP esetyenziswa kumazwe afana ne-United States, iYurophu, neJapan igxile ekuvelisweni kwesoftware, njengokulawula izenzo zabaqhubi kunye nendlela yokusingatha iziganeko ezingalindelekanga kwinkqubo yemveliso.

(1) Uthelekiso lweekhathalogu zeenkcukacha zesatifikethi. Kwiinto ezintathu kwinkqubo yokuvelisa amayeza - iinkqubo zehardware, iinkqubo zesoftware, kunye nabasebenzi - i-cGMP eMelika ilula kwaye inezahluko ezimbalwa kune-GMP eTshayina. Nangona kunjalo, kukho umahluko omkhulu kwiimfuno ezisisiseko zezi zinto zintathu. I-GMP yaseTshayina ineemfuno ezingaphezulu zehardware, ngelixa i-cGMP yase-United States ineemfuno ezingaphezulu zesoftware nabasebenzi. Oku kungenxa yokuba umgangatho wemveliso yamayeza uxhomekeke ngokusisiseko ekusebenzeni komqhubi, ngoko ke indima yabasebenzi kulawulo lwe-GMP eMelika ibaluleke ngakumbi kunezixhobo zasefektri.

(2) Uthelekiso lweziqinisekiso zomsebenzi. Kwi-GMP yaseTshayina, kukho imigaqo eneenkcukacha ngeziqinisekiso (inqanaba lemfundo) zabasebenzi, kodwa kukho imida embalwa kwiimbopheleleko zabasebenzi; Kwinkqubo ye-cGMP eMelika, iziqinisekiso (inqanaba loqeqesho) zabasebenzi zicacile kwaye zicacile, ngelixa uxanduva lwabasebenzi luchazwe ngokungqongqo. Le nkqubo yoxanduva iqinisekisa kakhulu umgangatho wemveliso yamayeza.

(3) Uthelekiso lokuqokelelwa kunye nokuhlolwa kweesampuli. I-GMP yaseTshayina ichaza kuphela iinkqubo zokuhlola ezifunekayo, ngelixa i-cGMP eMelika ichaza onke amanyathelo okuhlola kunye neendlela ngokweenkcukacha, inciphisa ukudideka kunye nongcoliseko lwamayeza kumanqanaba ahlukeneyo, ingakumbi kwinqanaba lezinto eziluhlaza, kwaye inika isiqinisekiso sokuphucula umgangatho wamayeza avela kumthombo.

 

Ubunzima ekuphunyezweni kwe-cGMP

Utshintsho lwe-GMP kwiinkampani zamayeza zaseTshayina lube lula. Nangona kunjalo, kusekho imingeni ekuphunyezweni kwe-cGMP, ebonakala kakhulu ekunyanisekeni kweenkcukacha kunye neenkqubo.

Umzekelo, inkampani yamayeza eYurophu ifuna ukungena kwimarike yase-US ineyeza lezinto eziluhlaza elithembisayo kwaye ingenise imveliso eqinisekisiweyo kwi-FDA yase-US. Ngaphambili, ngexesha lenkqubo yokwenziwa kwezinto eziluhlaza, bekukho ukuphambuka kokuchaneka kwenye yeegeyiji ezimbini zobushushu zetanki yokusabela. Nangona umqhubi wayecubungule waza wacela imiyalelo, abazange bayibhale ngokweenkcukacha kwiirekhodi zebhetshi yemveliso. Emva kokuba imveliso ivelisiwe, abahloli bomgangatho bajonga kuphela ukungcola okwaziwayo ngexesha lohlalutyo lwe-chromatographic, kwaye akukho ngxaki zifunyenweyo. Ke ngoko, kwakhutshwa ingxelo yokuhlola efanelekileyo. Ngexesha lokuhlolwa, amagosa e-FDA afumanise ukuba ukuchaneka kwe-thermometer akuhlangabezani neemfuno, kodwa akukho rekhodi zihambelanayo ezifunyenweyo kwiirekhodi zebhetshi yemveliso. Ngexesha lokuqinisekiswa kwengxelo yokuhlolwa komgangatho, kwafunyaniswa ukuba uhlalutyo lwe-chromatographic aluzange lwenziwe ngokwexesha elifunekayo. Zonke ezi zaphuli-mthetho ze-cGMP azinakubaleka ukujongwa ngabahloli, kwaye ekugqibeleni eli yeza alizange lingene kwimarike yase-US.

I-FDA igqibe kwelokuba ukungaphumeleli kwayo ukuthobela imithetho ye-cGMP kuya kuyonakalisa impilo yabathengi baseMelika. Ukuba kukho ukuphambuka kokuchaneka ngokweemfuno ze-cGMP, kufuneka kulungiselelwe uphando olongezelelekileyo, kuquka ukujonga iziphumo ezinokubakho zokuphambuka kokuchaneka kobushushu, kunye nokurekhoda ukuphambuka kwinkcazo yenkqubo. Lonke uhlolo lwamayeza lwenzelwe kuphela ukungcola okwaziwayo kunye nezinto ezingalunganga ezaziwayo, kwaye kwizinto ezingaziwayo ezinobungozi okanye ezingadibaniyo, azinakubonwa ngokupheleleyo ngeendlela ezikhoyo.

Xa sivavanya umgangatho weyeza, sihlala sisebenzisa iikhrayitheriya zokuhlola umgangatho ukuze siqinisekise ukuba iyeza liyafaneleka na okanye lisekelwe ekusebenzeni nasekubonakaleni kwemveliso. Nangona kunjalo, kwi-cGMP, ingcamango yomgangatho yindlela yokuziphatha esebenza kuyo yonke inkqubo yemveliso. Iyeza elifanelekileyo ngokupheleleyo lisenokungahlangabezani neemfuno ze-cGMP, njengoko kukho ithuba lokuphambuka kwinkqubo yalo. Ukuba akukho mfuneko ingqongqo yokulawula yonke inkqubo, iingozi ezinokubakho azinakubonwa ngeengxelo zomgangatho. Yingakho ukuphunyezwa kwe-cGMP kungelula kangako.