Isterile API
I-Sterile API sisiseko kunye nomthombo wamashishini okulungisa amayeza, kunye nenqanaba lokuqinisekisa umgangatho wemveliso lihambelana ngqo nokhuseleko lwamachiza.Ukuhluzwa kwezinto zolwelo kwinkqubo yokuvelisa kunye neninzi yezinyibilikisi ezibandakanyekayo, ngakumbi ukuhluzwa kwe-solvent ye-corrosive, kubeka phambili iimfuno ezingqongqo zokuhambelana kwemichiza ye-filter element.Ngokudibanisa neenkonzo zayo zokuqinisekisa inkqubo yelabhoratri, iDali ibonelela ngemveliso ethe gqolo yeemveliso zokucoca ezihlangabezana nemigangatho yenkqubo emiselweyo kunye neempawu zomgangatho kumashishini amayeza.
Ukulungiselela
Ukulungiswa kufuneka "ukuxuba" izinto eziluhlaza kwezinye ii-excipients okanye izinyibilikisi ukufikelela kugxininiso olufunekayo, kwaye ekugqibeleni zinokubonelelwa kwinto yokuhanjiswa kweziyobisi ukuze zisetyenziswe.Iindlela ezahlukeneyo zamalungiselelo zixazulula ingxaki yokusetyenziswa kweziyobisi kunye nethamo, kodwa zikwabeka phambili iimfuno eziphezulu zokhuseleko.Ukuze kugcinwe umfaniswano wokulungiselela kwaye uzinzile, izithako ezisebenzayo zihlangabezana neemfuno zamayeza, kunye nokulawula iingozi ezinokubakho, inkqubo kufuneka ixhotyiswe ngezisombululo ezichanekileyo zokucoca ukuqinisekisa ukuthotyelwa kunye nokhuseleko lokulungiselela kunye nokuhlangabezana neemfuno ze-GMP.
Ibhayoloji
I-Biotechnology ikhula ngokukhawuleza e-China.Njengenxalenye ebalulekileyo yamayeza anamhlanje kunye ne-biotechnology, iimveliso zebhayoloji zidlala indima ebaluleke kakhulu ekuthinteleni nasekunyangeni izifo kunye nokukhusela nokuphucula impilo yabantu.Iimveliso zebhayoloji zidinga iinkqubo ezininzi zebhayoloji kunye nokucocwa kunye nobuchule bokuhlalutya ukufumana ekujoliswe kuko.Ukuhluza okubonakalayo kuneenzuzo zendalo kwaye kunokugqiba imisebenzi ngokuyilayo.Yinkqubo eyimfuneko yeemveliso zebhayoloji.
Inkqubo yoLuntu
Inkqubo yoluntu kufuneka ibonelele ngemeko-bume ezinzileyo necocekileyo yokuvelisa.Amanzi, igesi, umoya oxinyiweyo kunye negesi ye-inert iya kuhlangabezana neemfuno zokucoceka kweenkqubo ezihambelanayo zamachiza, i-GMP kunye nezikhokelo kunye nemimiselo ehambelanayo.Amanzi afunekayo kwimveliso kwishishini lamachiza aphathwa ngokukodwa.Ukuze kuqinisekiswe ukucoceka kwesityalo okanye akukho ngcoliseko kwinkqubo yokuvundiswa, irhasi kufuneka icocwe kwaye ihluzwe.
Testing Instrument
Ukunyaniseka ngumba ophambili kwimveliso kunye nokusetyenziswa kwezinto zokucoca.Kwiinkqubo ezininzi zokucoca ulwelo (igesi okanye ulwelo), kuyafuneka ukuba kwandiswe ingqibelelo yesihluzi kwinqanaba lokugqibela lokuvelisa nasemva kokusetyenziswa kwangempela.Ke ngoko, isihluzo sokucoca ukutya kunye neziyobisi kufuneka sibe novavanyo olungqongqo lwengqibelelo, amaxwebhu ovavanyo kunye neerekhodi.