Izinga Lemininingwane
E-USA, imigomo ye-GMP ifakwe engxenyeni 210 kanye nengxenye 211 yekhodi yemithetho yenhlangano.Ngenxa yokuthi le mithetho inzima ukuyichibiyela noma ukwengeza, 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, ayinazo iziqondiso ezicacisiwe kanye nezidingo ngokuhambisana nemigomo ye-GMP.Esithasiselweni sohlelo luka-1998 lwe-GMP, izinhlobo eziyisithupha zezidakamizwa zalethwa nemihlahlandlela emifushane.Kuze kube manje, kusengenalutho ku-GMP ehlinzeka ngezinkomba eziqondisayo zokusebenza.Ukufaneleka kwemishini kanye nokuqinisekiswa, ukuqinisekiswa kwenqubo, ukuqinisekiswa kwendlela, ukuqinisekiswa kokuvala inzalo kanye nezinye izindlela zokusebenza ezithile zenziwe ngaphandle kwamazinga anemininingwane, okubangela ukuphathwa emuva.
Thumela umlayezo wakho kithi:
Isikhathi sokuthumela: Nov-03-2017