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

I-GMP (Good Manufacturing Practice) iwumhlahlandlela okuhloswe ngawo ukulawula nokwengamela imisebenzi yokukhiqiza imithi emhlabeni wonke.Kuyimvume edingekayo futhi kubakhiqizi bemithi ukuthi bangene emkhakheni wohwebo lwamazwe ngamazwe.

I-GMP ihlanganisa: indawo, abantu, indawo, inhlanzeko, ukuqinisekiswa, idokhumenti, ukukhiqizwa, ikhwalithi, ukudayiswa, ukusetshenziswa kabusha nokuhlola njll. Inemithetho eqinile yobuchwepheshe, isistimu yokuphatha kanye nokulawulwa kokuqinisekisa ukuvimbela: ukudideka phakathi kwezithako, ukutheleleka kanye nokungcola okuvela eminye imithi, ukuhluka kanye nokuchezuka ekuxubeni kwezingxenye ezihlukene, izingozi zezinyathelo ezingekho zokuhlola, ukuhlinzwa okunephutha kanye nenye inqubo engafanele.

Umqondo we-GMP wakhuliswa ngawo-80s waseChina futhi wamenyezelwa ngokusemthethweni njengomthethonqubo ophelele futhi oyisibopho ngoJulayi 1.^st, 1999. E-USA, i-cGMP (ifushane Yemikhuba Yamanje Yokukhiqiza Okuhle) yakhululwa ku-CFR ingxenye 210 kanye nengxenye 211 ngeminyaka yama-90s.

Sekukonke, inhloso, umgomo, isihloko kanye nemfuneko ye-Chinese GMP icishe ifane neye-American cGMP kodwa ngempela kukhona umehluko omningi kanje.

Inqubo Yokuvunyelwa

Isitifiketi se-GMP yase-Chinese siyisitifiketi kuphela semvume yokukhiqiza imithi, ngaphandle kokubhaliswa komkhiqizo.Ngemva kokuba umenzi egunyazwe umkhiqizo omusha ngenombolo yokubhalisa, uyakwazi ukuqhubeka nokufaka isicelo sesitifiketi se-GMP.Ngaphezu kwalokho, idatha yamaqoqwana amathathu okukhiqiza kanye nedatha yokuhlolwa kokuzinza okungenani ezinyangeni eziyisithupha iyadingeka ukuthunyelwa kokubhaliswa komkhiqizo noma isitifiketi se-GMP.

Ukuqinisekiswa kwe-cGMP yaseMelika kuqukethe izingxenye ezimbili: Ukuthuthukiswa Komkhiqizo kanye Nokulawula Ukukhiqiza Amakhemikhali.Lokho kusho ukuthi ukubhaliswa kokukhiqiza kanye nemvume yokukhiqiza kuyaqhubeka ngesikhathi esifanayo.Kunezinhlobo ezimbili zokubhaliswa komkhiqizo e-USA: Isicelo Esisha Sezidakamizwa (i-NDA) kanye Nesicelo Sesidakamizwa Esisha Esifushanisiwe (i-ANDA).I-NDA idinga idatha yamaqoqo amathathu okukhiqiza kanye nedatha yokuhlola ukuzinza ezinyangeni eziyisithupha.I-ANDA idinga idatha yeqoqo lokukhiqiza kanye nedatha yokuhlola ukuzinza ezinyangeni ezintathu.Idatha yokuhlola okuqhubekayo nokuqinisekiswa izogcinwa umkhiqizi futhi imenyezelwe embikweni wonyaka oya ku-FDA.

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