Ukuthobela kunye nokuqinisekiswa komgangatho
Ukufunyanwa kwethu kits zenziwa phantsi kwe-SO 13485: iinkqubo zokulawulwa komgangatho wama-2016, ukuqinisekisa ukungqinelana, ukuthembeka kunye nokulandelela. Sibambelela kwiinkqubo zokwenza imveliso (i-GMP) apho kufanelekileyo, kuqinisekisa ukuba ii-regents zethu zihlangabezana nezona zixhobo ziphezulu zecandelo.
UKUSETYENZISWA KOKUSETYENZISWA KOKUSETYENZISWA
Iimveliso zethu zezophando zisetyenziswa kuphela (i-ruo) kwaye akufuneki zisetyenziswe kimeko zeklinikhi okanye kunyango lomntu.
Zilungiselelwe ukuba ube nophawu lwemveliso yeseli, uvavanyo lokhuseleko, kunye nokubekwa kweliso kwimpembelelo.
Abasebenzisi kufuneka balandele iiprothokholi ezifanelekileyo zelebhu kunye nezikhokelo ze-biosafsety xa ziphatha ii-regentants zethu.
Ukuqwalaselwa kolawulo
Inkxaso yethu yokuHlawula i-RDA (i-21 cfr Icandelo 210/211), i-EMA ye-EMAIL (i-EMA YE-EUROFA), kunye ne-Ich (i-Ich (iBhunga leMfundo leNkqubo yokuHanjiswa kweSeli.
Ngelixa i-kits zethu ayizizo ii-FDA - ivunyiwe ukuba isetyenziswe ekliniki, ziyanceda ekuhlangabezeni iimpawu ezisemgangathweni (CQA) ezifunekayo zokungeniswa komthetho.
Ukhuseleko & nokuphatha
Zonke ii-Regars zilawula ngokungqongqo
Iimeko ezifanelekileyo zokugcina kunye neenkqubo zokuphatha kufuneka zilandelwe njengoko kuchaziwe kumaxwebhu emveliso.
Abasebenzisi kufuneka babhekise kwi-STHESS yokhuseleko lwezinto ezibonakalayo (i-MSDS) yeZikhokelo zeHazard.
Uxanduva lwabathengi
Abathengi banoxanduva loku:
Ukuqinisekisa ukwenziwa kwethu kwezicelo zabo ezithile.
Ukuqinisekisa ukuthotyelwa kwemigaqo yendawo yovavanyo lwemveliso yeseli.
Sebenzisa iimveliso zethu kuphela kwiinjongo zabo zophando.
Ngeenkcukacha ezithe vetshe, nceda ujonge incwadana yethu yeMveliso okanye uqhagamshelane neqela lethu lenkxaso kubuchwephesha kwi-Bluekitbio@hillgene.com.
I-BlueKitbio-Ukuqhubela phambili kophando lonyango lweseli ngokuchaneka kunye nokuThobela
IXESHA LOKUQALA: 2025 - 05 - 14:25:25:25
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