UYAYAZI YINTONI i-cGMP?

Yintoni i-cGMP?

Iyeza lokuqala lehlabathi le-GMP lazalelwa eUnited States ngo-1963. Emva kohlaziyo oluninzi kunye nokutyebisa okuqhubekayo kunye nokuphuculwa yi-US FDA, i-cGMP (IiNdlela zokuSebenza eziLungileyo zangoku) eUnited States iye yaba ngomnye wabameli beteknoloji ephezulu kwi-GMP. ibala, idlala indima ebaluleke ngakumbi ekusetyenzisweni okukhuselekileyo nokuphumelela kwamachiza kwihlabathi liphela.I-China yaqala ukubhengeza ichiza elisemthethweni le-GMP ngo-1988, kwaye liye lahlaziywa ubukhulu becala kathathu ukususela ngo-1992, 1998, kunye no-2010, lisafuna ukuphuculwa okungakumbi.Ngethuba leminyaka engaphezulu kwe-20 yokukhuthaza umsebenzi we-GMP yechiza e-China, ukusuka ekwaziseni ingqikelelo ye-GMP ukuya ekukhuthazeni ukuqinisekiswa kwe-GMP, impumelelo ngezigaba iphunyeziwe.Nangona kunjalo, ngenxa yokuqaliswa kade kwe-GMP e-China, kuye kwakho izinto ezininzi zokusebenzisa i-GMP ngoomatshini, kwaye intsingiselo ye-GMP ayidityaniswanga ngokwenyani kwimveliso kunye nolawulo lomgangatho.

 

Uphuhliso lwe-cGMP

Iimfuno zangoku ze-GMP e-China zisekho "kwinqanaba lokuqala" kwaye ziimfuno ezisemthethweni kuphela.Ukuze amashishini aseTshayina angene kwimarike yamazwe ngamazwe kunye neemveliso zawo, kufuneka alungelelanise ulawulo lwawo lwemveliso kunye nemigangatho yamazwe ngamazwe ukuze afumane ukuqondwa kwemarike.Nangona urhulumente waseTshayina engekagunyazisi iinkampani ezixuba amayeza ukuba ziphumeze i-cGMP, oku akuthethi ukuba akukho ngxamiseko yokuba iTshayina iphumeze i-cGMP.Ngokuchaseneyo noko, ukulawula yonke inkqubo yemveliso ngokwemigangatho ye-cGMP yinto efunekayo ukuze uhambele phambili ekufikeleleni kumazwe ngamazwe.Ngethamsanqa, okwangoku e-China, iinkampani zonyango ezinezicwangciso zophuhliso ezijonge phambili ziye zaqonda ukubaluleka kwexesha elide lo mmiselo kwaye ziwusebenzisa.

Imbali yoPhuhliso lwe-cGMP: I-cGMP eyamkelwe kumazwe ngamazwe, nokuba ise-United States okanye eYurophu, ngoku ukuhlolwa kokuthotyelwa kwe-cGMP kwiindawo zemveliso ilandela iinkcukacha ezidityanisiweyo ze-cGMP zemathiriyeli ekrwada equlunqwe yiNkomfa yaMazwe ngaMazwe eHarmonization (ICH), nekwaziwa njenge-ICH Q7A. .Le ngcaciso yavela kwiNkomfa yaMazwe ngaMazwe ngeHarmonization of Raw Materials (ICH ye-API) eGeneva, eSwitzerland ngoSeptemba 1997. NgoMatshi ka-1998, ikhokelwa yi-US FDA, "i-cGMP yezinto eziluhlaza", i-ICH Q7A, yabhalwa.Ekwindla ka-1999, i-European Union kunye ne-United States zafikelela kwisivumelwano sokuqaphela okufanayo kwe-cGMP kwizinto eziluhlaza.Emva kokuba isivumelwano siqale ukusebenza, omabini amaqela avumile ukuqaphela iziphumo zesatifikethi se-cGMP zomnye kwinkqubo yorhwebo lwemathiriyeli ekrwada.Kwiinkampani ze-API, imigaqo ye-cGMP ngokwenene ingumxholo we-ICH Q7A.

 

Umahluko phakathi kwe-cGMP kunye ne-GMP

I-CGMP ngumgangatho we-GMP ophunyezwe ngamazwe afana ne-United States, iYurophu, kunye neJapan, eyaziwa ngokuba "ngumgangatho we-GMP wamazwe ngamazwe".Imigangatho ye-cGMP ayilingani nemigangatho ye-GMP ephunyezwe e-China.

Ukuphunyezwa kwemigaqo ye-GMP e-China yiseti yemigaqo ye-GMP esebenzayo kumazwe asakhulayo aqulunqwe yi-WHO, ngokugxininisa ngokukodwa kwiimfuno ze-hardware yokuvelisa ezifana nezixhobo zokuvelisa.

I-cGMP iphunyezwe kumazwe afana ne-United States, iYurophu, kunye neJapan igxile kwimveliso yesofthiwe, njengokulawula izenzo zabaqhubi kunye nendlela yokusingatha iziganeko ezingalindelekanga kwinkqubo yokuvelisa.

(1) Ukuthelekiswa kweekhathalogu ezichaza iziqinisekiso.Kwizinto ezintathu kwinkqubo yokuveliswa kweziyobisi - iinkqubo ze-hardware, iinkqubo zesofthiwe, kunye nabasebenzi - i-cGMP e-United States ilula kwaye inezahluko ezimbalwa kune-GMP e-China.Nangona kunjalo, kukho umahluko omkhulu kwiimfuno zendalo kwezi zinto zintathu.I-GMP yaseTshayina ineemfuno ezininzi zehardware, ngelixa i-cGMP yase-United States ineemfuno ezingakumbi zesoftware kunye nabasebenzi.Oku kungenxa yokuba umgangatho wokuveliswa kwamachiza ngokusisiseko uxhomekeke ekusebenzeni komsebenzisi, ngoko ke indima yabasebenzi kulawulo lwe-GMP eUnited States ibaluleke ngakumbi kunaleyo yezixhobo zasefektri.

(2) Ukuthelekiswa kweziqinisekiso zomsebenzi.Kwi-GMP yaseTshayina, kukho imigaqo ecacileyo malunga neziqinisekiso (inqanaba lemfundo) labasebenzi, kodwa kukho imiqobo embalwa kwiimfanelo zabasebenzi;Kwinkqubo ye-cGMP e-United States, iziqinisekiso (inqanaba loqeqesho) lwabasebenzi zifutshane kwaye zicacile, ngelixa uxanduva lwabasebenzi luchazwe ngokungqongqo.Le nkqubo yoxanduva iqinisekisa ubukhulu becala umgangatho wemveliso yamachiza.

(3) Ukuthelekiswa kokuqokelela isampula kunye nokuhlolwa.I-GMP yaseTshayina ichaza kuphela iinkqubo eziyimfuneko zokuhlola, ngelixa i-cGMP e-United States ichaza onke amanyathelo okuhlola kunye neendlela ngokweenkcukacha ezinkulu, ukunciphisa ukudideka kunye nokungcoliswa kwamachiza kwizigaba ezahlukeneyo, ngakumbi kwinqanaba lezinto eziluhlaza, kunye nokubonelela ngesiqinisekiso sokuphucula umgangatho wamachiza ukusuka. umthombo.

 

Ubunzima bokuphumeza i-cGMP

Utshintsho lwe-GMP lwamashishini oxubo mayeza aseTshayina lube lula.Nangona kunjalo, kusekho imingeni ekuphumezeni i-cGMP, ebonakaliswa ikakhulu kukunyaniseka kweenkcukacha kunye neenkqubo.

Umzekelo, inkampani exuba amayeza eYurophu ifuna ukungena kwimakethi yase-US ngeyeza elithembisayo lezinto ezikrwada kwaye ingenise imveliso eqinisekisiweyo kwi-US FDA.Ngaphambili, ngexesha lenkqubo yokwenziwa kwezinto ekrwada, bekukho ukutenxa ngokuchanekileyo kwenye yeegeyiji ezimbini zobushushu betanki yokusabela.Nangona umqhubi wayeqhubekile kwaye wacela imiyalelo, abazange bayibhale ngokucacileyo kwiirekhodi zebhetshi zokuvelisa.Emva kokuveliswa kwemveliso, abahloli bekhwalithi bahlolwe kuphela ukungcola okwaziwayo ngexesha lokuhlalutya i-chromatographic, kwaye akukho zingxaki zifunyenwe.Ngoko ke, ingxelo yohlolo olufanelekileyo yakhutshwa.Ngethuba lokuhlolwa, amagosa e-FDA afumanisa ukuba ukuchaneka kwe-thermometer akuzange kuhlangabezane neemfuno, kodwa akukho zirekhodi ezihambelanayo ezifunyenwe kwiirekhodi zebhetshi zokuvelisa.Ngethuba lokuqinisekiswa kwengxelo yokuhlola umgangatho, kwafunyaniswa ukuba uhlalutyo lwe-chromatographic aluzange lwenziwe ngokwexesha elifunekayo.Konke oku kunyhashwa kwe-cGMP akunakubaleka kuphononongo lwe-censors, kwaye eli chiza ekugqibeleni lasilela ukungena kwimarike yase-US.

I-FDA inqume ukuba ukungaphumeleli kwayo ukuthobela imigaqo ye-cGMP kuya kwenzakalisa impilo yabathengi baseMelika.Ukuba kukho ukutenxa ngokuchanekileyo ngokweemfuno ze-cGMP, uphando olongezelelweyo kufuneka lulungiswe, kubandakanywa ukujonga iziphumo ezinokwenzeka zokuphambuka kweqondo lokushisa ukusuka ekuchanekeni, kunye nokurekhoda ukutenxa kwinkcazo yenkqubo.Konke ukuhlolwa kwamachiza kuphela kukungcola okwaziwayo kunye nezinto ezingalunganga ezaziwayo, kunye nezinto ezinobungozi ezingaziwayo okanye ezingahambelaniyo, azikwazi ukufunyanwa ngokubanzi ngeendlela ezikhoyo.

Xa sivavanya umgangatho wechiza, sihlala sisebenzisa iindlela zokuhlola umgangatho ukufumanisa ukuba ichiza lifanelekile na okanye lisekelwe kwimpumelelo kunye nenkangeleko yemveliso.Nangona kunjalo, kwi-cGMP, ingqikelelo yomgangatho sisiqhelo sokuziphatha esiqhuba kuyo yonke inkqubo yemveliso.Ichiza eliqeqeshwe ngokupheleleyo alinako ukuhlangabezana neemfuno ze-cGMP, njengoko kukho ithuba lokutenxa kwinkqubo yalo.Ukuba akukho mfuneko zingqongqo zolawulo lwenkqubo yonke, iingozi ezinokubakho azinakubonwa ngeengxelo zomgangatho.Kungenxa yoko le nto ukuphunyezwa kwe-cGMP kungekho lula njengaleyo.