Ngaba uyazi ukuba yintoni i-CGMP?

Yintoni i-CGMP?

I-GWIT ye-GEMBilitsha yeHlabathi yazalelwa eUnited States ngo-1963. Emva kohlaziyo oluninzi kunye nokuphuculwa kwe-US FA, i-CGMP (i-CGMP (i-CGMP (i-CGMP (i-CGMP (i-United States iye yaba ngomnye wabameli kwi-GMP Intsimi, idlale indima ebaluleke kakhulu kwiZiyobisi ezikhuselekileyo neziKhuselekileyo zeHlabathi. I-China iqale yaphinda yafaka i-GMP eyoyileyo ye-GEMP ngo-1988, kwaye ixhaphake ikakhulu ukusasazwa ezintathu ukusukela ngo-1992, ngo-1998, ngo-2010, kunye no-2010, kunye no-2010, kunye no-2010, kunye no-2010, kunye no-2010, kusafuneka uphuculo. Ngexesha elingaphezulu kweminyaka engama-20 yokukhuthaza umsebenzi we-GPE weziyobisi eTshayina, ekusayinisweni kwento ye-GMP ekukhuthazeni isiqinisekiso se-GMP, impumelelo efunyenweyo ifezekisiwe. Nangona kunjalo, ngenxa yokuqalisa kade kwe-GPM e China, kuye kwakho izinto ezininzi zokufaka i-GMP, kwaye intsingiselo ye-GMP ayizange idityaniswe ngokwenyani kwimveliso kunye nolawulo lomgangatho.

 

Uphuhliso lwe-CGMP

Iimfuneko ze-GMP ezikhoyo e-China zise "Inqanaba lokuqala" kwaye ziyimfuneko ngokusesikweni kuphela. Ukwenzela ukuba amashishini aseTshayina angene kwimakethi yamanye amazwe kwiimveliso zawo, kufuneka balungelelanise ulawulo lwabo lwemveliso kunye nemigangatho yamazwe ngamazwe ukwenzela ukufumana ingqalelo yentengiso. Nangona urhulumente waseTshayina engekayigunyaziswa iinkampani zamayeza ukuba zisebenzise i-CGMP, oku akuthethi ukuba akukho kungxamiseko e China yokuphumeza i-CGMP. Ngokwahlukileyo koko, ukulawula yonke inkqubo yemveliso ngokwemigangatho ye-CGMP yimfuneko ebalulekileyo yokufudukela kwizakhiwo kwilizwe lonke. Ngethamsanqa, okwangoku e-China, iinkampani zamayeza ezineendlela zokuphuhliswa kokujonga phambili ziye zakuqonda ukubaluleka kwexesha elide lo mmiselo kwaye uzisebenzise.

Imbali yoPhuculo lwe-CGMP: I-CGMP eyamkelwe kwilizwe lonke, nokuba i-United States okanye eYurophu, okwangoku i-CGMP yokuhlolwa kwe-CGMP ilandela inkomfa ye-CGMP elandela inkomfa ye-CGMP ehambelana ne-ich q7a . Esi sichazi-magama sivela kwiNkomfa yeHlabathi yokuHanjiswa kwezinto eziluhlaza (ich kwi-geneva, eSwitzerland ngo-Septemba ". Ngo-Matshi ka-1998, i-Ich Q7a, yalelwa. Ekwindla yonyaka ka-1999, i-European Union kunye ne-United States zafikelela kwiSivumelwano sokuqonda isiqinisekiso se-CPMPIUL SIPOST. Emva kokuba isivumelwano saqala ukusebenza, omabini la maqela avumile ukuba aqaphele iziphumo zeCGMP's CGMP kwinkqubo yorhwebo yezixhobo eziluhlaza. Kwiinkampani ze-API, imigaqo ye-CGMmp ngowona mxholo othile we-Ich Q7A.

 

Umahluko phakathi kwe-CGMP kunye ne-GMP

I-CGMP ngumgangatho we-GPMS ophunyezwa ngamazwe anjenge-United States, iYurophu, neJapan, ekwabizwa ngokuba yi "mgangatho we-GEMPING". Imigangatho ye-CGMP ayifanelanga nemigangatho ye-GPE ephunyezwe eChina.

Ukuphunyezwa kweMigaqo ye-GPM e-China yiseti yemimiselo ye-GPM esebenzayo kumazwe asaphuhlayo aphunyiwe ngu-WHO, ngokugxininiswa okuthile kwiimfuno zokuvelisa ezifana nezixhobo zemveliso.

I-CGMP iphunyeziselwe kumazwe anjenge-United States, iYurophu, kwaye iJapan igxile ekuvelisweni kwesoftware, njengokulawula izazisi zabaqhubi kunye nendlela yokuphatha iziganeko ezingalindelekanga kwinkqubo yemveliso.

(1) Ukuthelekisa kwekhathalogu yokucacisa. Kwizinto ezintathu kwinkqubo yemveliso yeziyobisi - iinkqubo ze-Hardware, iinkqubo zesoftware, kunye nabasebenzi - i-CGMP kwi-United States ilula kwaye inee-v Nangona kunjalo, kukho umahluko obonakalayo kwiimfuno ezisisiseko kwezi zinto zintathu. I-GMP kaChina ineemfuno ezininzi kwizixhobo ze-Hardware, ngelixa i-CGUMP yaseMelika ineemfuno ezininzi kwisoftware nabasebenzi. Oku kungenxa yokuba umgangatho wokuvelisa weziyobisi ngokusisiseko uxhomekeka ekusebenzeni komsebenzi, ke yona indima yabasebenzi kulawulo lwe-GPP e-United States ibaluleke ngakumbi kuneso sixhobo somzi-mveliso.

(2) Uthelekiswa neziqinisekiso zomsebenzi. Kwi-frican ye-china, kukho imigaqo eneenkcukacha kumabanga emfundo (inqanaba lemfundo) labasebenzi, kodwa zimbalwa iingxaki zabasebenzi; Kwinkqubo ye-CGMP kwi-United States, amabanga emfundo (inqanaba loqeqesho) lwabasebenzi lichanekile kwaye licacile, ngelixa uxanduva lwabasebenzi lucacisiwe. Inkqubo enoxanduva kakhulu iqinisekisa umgangatho wokuvelisa amachiza.

(3) Ukuthelekisa ingqokelela kunye novavanyo. I-GEMP yaseTshayina icacisa kuphela iinkqubo zokuhlola ezifanelekileyo, ngelixa i-CGMP eUnited States ichaza onke amanyathelo ahlonitshwayo, ukunciphisa ukudideka kwezixhobo, ngakumbi kwinqanaba lokuphucula umgangatho weziyobisi ukusuka umthombo.

 

Ubunzima ekuphumezeni i-CGMP

Inguqu ye-GMP yamashishini aseTshayina athambekele. Nangona kunjalo, kusekho imiceli mngeni ekuphumezeni i-CGMP, ikakhulu ibonakaliswe kubunyani beenkcukacha kunye neenkqubo.

Umzekelo, inkampani yamayeza e-Europe efuna ukungena kwimakethi yase-US ngesiyobisi esikhuselweyo kwaye singenisa imveliso eqinisekisiweyo kwi-US FDA. Ngaphambili, ngexesha lenkqubo ye-Synthesi ye-Synthesi, kukho ukuphambuka ngokuchanekileyo kwelinye le gegus ezimbini zetanki lokuphendula. Nangona umqhubi egqibile kwaye wacela imiyalelo, abayibhalisanga ngokweenkcukacha kwiirekhodi zemveliso yemveliso. Emva kokuba kuveliswe imveliso, abahloli abasemgangathweni bahlole kuphela ukungcola okwaziwayo ngexesha lohlalutyo lweChromatographic, kwaye akukho ngxaki. Ke ngoko, kwakhutshwa ingxelo yovavanyo ofanelekileyo. Ngexesha lokuhlolwa, amagosa e-FDA afumanisa ukuba ukuchaneka kwethemometer kungafezekisi iimfuno, kodwa akukho zirekhodi zihambelana nazo kwiirekhodi ze-batch zemveliso. Ngexesha lokuqinisekiswa kwengxelo yovavanyo esemgangathweni, kwafunyaniswa ukuba uhlalutyo lwe-chromatographic aluzange lwenziwe ngokwexesha elifunekayo. Zonke ezi zinto zophulo ze-CGMM azinakubaleka ukuqatshelwa kwabaqeshwa, kwaye eli chiza liphumelele ukungena kwimarike yaseMelika.

I-FDA igqibe ekubeni ukusilela kwayo ukuthobela imigaqo-nkqubo ye-CGMP kuya kwenzakalisa impilo yabathengi baseMelika. Ukuba kukho ukuphambuka ngokuchaneka ngokweemfuno ze-CGMP, kuqhubekiswa ngakumbi, kubandakanya ukukhangela iziphumo zokuphambuka kobushushu bokuchama, kwaye ukurekhoda ukuphambuka kwinkcazo yenkqubo. Lonke uhlolo lwamachiza kuphela lokungcola kwaziwa kuphela kunye nezinto ezaziwayo, kunye nezinto ezinobungozi okanye ezingaziwayo, azinakho ukufunyanwa ngokuqiniswa ngeendlela ezikhoyo.

Xa kuvavanywa umgangatho wechiza, sisoloko sisebenzisa iikhrayitheriya zokuhlolwa komgangatho ukufumanisa ukuba ichiza liqeqeshiwe okanye lisekwe kwimpumelelo kunye nembonakalo yemveliso. Nangona kunjalo, kwi-CGMP, umxholo womgangatho ngumgangatho wokuziphatha oqhuba yonke inkqubo yemveliso. Isiyobisi esifanelekileyo esifanelekileyo asinakuzifikelela kwiimfuno ze-CGMP, njengoko kukho ithuba lokuphambuka kwinkqubo yalo. Ukuba azikho iimfuno ezingqongqo ezingqongqo kuyo yonke inkqubo, iingozi ezinokubakho azinakufunyanwa ngeengxelo zomgangatho. Kungenxa yoko le nto i-CGMP ayilula njengaleyo.