Umehluko Phakathi kwe-American CGMP kanye ne-Old Chinese GMP (Ingxenye II)

Izinga Lemininingwane

E-USA, imigomo ye-GMP ifakwe engxenyeni 210 kanye nengxenye 211 yekhodi yemithetho yenhlangano.Ngenxa yokuthi le mithethonqubo kunzima ukuyichibiyela noma ukungeza, i-FDA ikhiphe imibhalo ehlukene yemithetho ye-GMP kanye neziqondiso zokusebenza kwezemithi, njenge.Isiqondiso Sezimboni.Lawa mafayela achibiyelwa njalo nangezwe abizwa ngokuthi imihlahlandlela ye-CGMP.Eminye yale mihlahlandlela ihlobene nocwaningo nokubhaliswa kwezidakamizwa ezintsha, njenge-ICH (Q1-Q10).Ukwenziwa kanjani ukuqinisekiswa kwendlela, ukuqinisekiswa kwenqubo nokunye okuqukethwe nge-GMP nakho kufakiwe kula madokhumenti, okungamazinga athotshelwayo ekuhlolweni kwe-GMP endaweni.Ngaphezu kwalokho, eminye imihlahlandlela ikhishelwa abahloli be-GMP njengezinkomba, njengeUmhlahlandlela Wokuhlolwa Kwefomu Lomthamo Wabakhiqizi Bezidakamizwa, Umhlahlandlela Wokuhlolwa Kwezinhlelo Zekhwalithi, Ukuqinisekiswa Kwezinqubo Zokuhlanzanjll. Akuphoqelekile ukusebenzisa le mihlahlandlela.Ngenxa yokuthi abahloli be-FDA kuphela abagunyazwe ukunquma ukuthi inqubo yokusebenza komkhiqizi iyahlangabezana yini naleli zinga "lamanje", abakhiqizi bezidakamizwa kufanele balandele i-cGMP yakamuva kanye neminye imihlahlandlela futhi bazihlole bona ukuthi izindinganiso zenziwe.Uma kungenjalo, bazobhekwa “njengabangagunyaziwe” futhi bajeziswe ngakho.

 I-Chinese GMP (uhlelo lwango-1998) ilula kakhulu futhi ayicacile, ayinayo imihlahlandlela ecacisiwe kanye nezidingo ngokuhambisana nemigomo ye-GMP.Esithasiselweni sohlelo lwe-GMP lwango-1998, izinhlobo eziyisithupha zezidakamizwa zalethwa nemihlahlandlela emifushane.Kuze kube manje, kusengenalutho ku-GMP ehlinzeka ngezinkomba eziqondisayo zokusebenza.Ukufaneleka kwemishini nokuqinisekiswa, ukuqinisekiswa kwenqubo, ukuqinisekiswa kwendlela, ukuqinisekiswa kokuvala inzalo kanye nezinye izindlela zokusebenza ezithile zenziwe ngaphandle kwamazinga anemininingwane, okubangela ukuphathwa emuva.

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