I-Genobio Ithola Isitifiketi Se-MDSAP——Izinga Eliphezulu Lokulawula Embonini Yokukhiqiza Idivayisi Yezokwelapha

Tianjin, eChina - Mashi 18, 2022 - I-Genobio Pharmaceutical Co., Ltd, inkampani ephethwe ngokuphelele ye-Era Biology Group, ehola phambili futhi iphayona emkhakheni wokuxilongwa kwezifo ezikhunta kusukela ngo-1997, iyajabula ukumemezela ukuthi iGenobio isivuselele isitifiketi. ukuze kuphothulwe ngempumelelo ukuhlolwa kwe-Quality Management System ngaphansi kwe-Medical Device Single Audit Programme (MDSAP).

I-MDSAP iyinqubo yokucwaninga eqinile evumela inhlangano ecwaningayo eyaziwayo ukuthi yenze ukuhlola okukodwa kokulawula komkhiqizi wedivaysi yezokwelapha, ngaphezu kwe-ISO13485:2016, enelisa izidingo ezifanele zeziphathimandla ezilawulayo ezibamba iqhaza ohlelweni, okuhlanganisa nalezo ezikuhlelo. Canada, United States kanye Brazil.

MDSAP

Amayelana ne-Era Biology Group

Ukuvulwa Okukhulu "kwe-National Marine Economic Innomic and Development (Beihai) Industrial Park kanye ne-Beihai Sinlon Chinese Horseshoe Crabs Marine Medicine Industrial Park"

Era Biology Group eyasungulwa ngo-1997. Ingumholi nengqalabutho yomkhakha wokuxilonga izifo ezikhuntayo.Indlunkulu itholakala eTianjin, eChina.Kuze kube ngu-2022, izinkampani ezingaphansi eziyisishiyagalombili eziphethwe ngokuphelele zisungulwa e-Beijing, e-Tianjin, e-Suzhou, e-Guangzhou, e-Beihai, e-Shanghai nase-Canada.E-China, i-Era Biology iyibhizinisi elihamba phambili emkhakheni wokuxilongwa kwe-in vitro fungus.I-Era Biology iklonyeliswe nge-Marine Economic Innovation Development Demonstration Project yi-National Oceanic Administration kanye noMnyango Wezezimali.Ngo-2017, i-Era Biology yabhala izinga lezimboni zasekhaya le-"Fungus (1-3)-β-D-Glucan Test" kanye ne-National Center for Clinical Laboratories. Emhlabeni jikelele, i-Era Biology iphumelele ukuqinisekiswa kwe-CMD ISO 9001, ISO 13485, I-Korea GMP ne-MDSAP, futhi imikhiqizo inezitifiketi ze-CE, NMPA kanye ne-FSC. Inamathela esiqubulweni esithi “Ukuqanjwa Okusha Kwempilo Engcono”, i-Era Biology igcizelela ekulawuleni izinga eliphezulu nokulawula okuqinile kuyilapho iqhubeka nocwaningo nentuthuko olwengeziwe.


Isikhathi sokuthumela: Mar-29-2022