Ogosto 19-keedii, Beijing Innovita Biological Technology Co., Ltd. ("INNOVITA") waxay heshay shahaadada MDSAP, oo ay ku jiraan Mareykanka, Japan, Brazil, Canada, iyo Australia, taas oo ka caawin doonta INNOVITA inay sii furto suuqa caalamiga ah.
Magaca buuxa ee MDSAP waa Aaladda Caafimaadka Hal Audit Program, kaas oo ah hal barnaamij oo hanti dhawr ah oo loogu talagalay aaladaha caafimaadka.Waa mashruuc ay si wada jir ah u bilaabeen xubnaha Ururka Caalamiga ah ee Nidaaminta Aaladaha Caafimaadka (IMDRF).Ujeeddadu waa in hay'adda hanti-dhawrka qolo saddexaad oo u qalma ay samayn karto xisaab hubinta soo-saareyaasha qalabka caafimaadka si ay u buuxiyaan shuruudaha QMS/GMP ee kala duwan ee waddamada ka qaybgalaya.
Mashruuca waxaa ansixiyay shan hay'adood oo sharciyeysan, Maamulka Cuntada iyo Dawooyinka ee Maraykanka, Wakaaladda Caafimaadka Kanada, Maamulka Alaabada Daaweynta ee Australia, Wakaaladda Caafimaadka Brazil iyo Wasaaradda Caafimaadka, Shaqada iyo Daryeelka ee Japan.Waxaa xusid mudan in shahaadadani ay bedeli karto qaar ka mid ah hanti-dhawrka iyo kormeerka joogtada ah ee dalalka aan kor ku soo xusnay, isla markaana la heli karo suuq, sidaas awgeed shuruudaha shahaadooyinka ayaa ah kuwo aad u sarreeya.Tusaale ahaan, Health Canada waxay ku dhawaaqday in laga bilaabo Jannaayo 1, 2019, MDSAP ay si khasab ah u beddeli doonto CMDASs sidii barnaamijka dib u eegista agabka caafimaadka Kanada.
Helitaanka shahaadada nidaamka shanta waddan ee MDSAP ma aha oo kaliya aqoonsiga sare ee INNOVITA iyo alaabteeda Australia, Brazil, Canada, Maraykanka, iyo Japan, laakiin sidoo kale waxay ka caawisaa INNOVITA inay sii wado ballaarinta miisaanka diiwaangelinta dibadda ee ay cusub. reagents tijaabinta taaj.Waqtigan xaadirka ah, INNOVITA's 'Covid-19's tijaabooyin ayaa laga diiwaan geliyay ku dhawaad 30 waddan, oo ay ku jiraan Mareykanka, Brazil, France, Italy, Russia, Spain, Portugal, the Netherlands, Hungary, Austria, Sweden, Singapore, Philippines, Malaysia, Thailand , Argentina, Ecuador, Colombia, Peru, Chile, Mexico, iwm.
Waxaa la sheegay in INNOVITA ay wali dardargelinayso codsiga diiwaangelinta dalal badan iyo machadyo, iyada oo balaadhinaysa baaxadda diiwaangelinta dibedda ee imtixaannada Covid-19, oo ay ku jiraan codsashada shahaadada EU CE (is-tijaabinta) iyo US FDA tijaabada cusub ee 'Covid-19 antigen'. diiwaangelinta xirmada.
Cudurka faafa ee adduunka ayaa sii fidaya.Xirmooyinka tijaabada ee INNOVITA ee 'Covid-19' ayaa laga iibiyay in ka badan 70 waddan iyo gobollo, waxayna sameeyeen baaritaanno sax ah, degdeg ah oo ballaaran oo loogu talagalay fayraska SARS-CoV-2, iyagoo door muhiim ah ka qaadanaya dagaalka caalamiga ah ee ka dhanka ah Covid-19. xanuun saf-mar ah.
Waqtiga boostada: Oct-18-2021