Ukuhambisana nokuqinisekiswa kwekhwalithi
Ama-kits ethu okutholwa akhiqizwa ngaphansi kwe-ISO 13485: Izindlela zokulawulwa kwekhwalithi 2016, ukuqinisekisa ukungaguquguquki, ukuthembeka, kanye nokulandela umkhondo. Sinamathela ekwenzeni izinto ezinhle zokukhiqiza (i-GMP) lapho kufanele khona, kuqinisekisa ukuthi ama-reagents ethu ahlangana namabhentshi aphezulu kakhulu embonini.
Ukusetshenziswa Okuhlosiwe & Ukulinganiselwa
Imikhiqizo yethu yenzelwe ukucwaninga kuphela (Ruo) futhi akufanele isetshenziswe ekuhlolweni kwemitholampilo noma ekwelashweni kwabantu.
Balungiselelwe ukuqondiswa komkhiqizo okwenziwa kuselula, ukuhlolwa kokuphepha, nokuhlola inqubo.
Abasebenzisi kumele balandele izimiso ezifanele zelebhu kanye nezinkombandlela ze-biosafety lapho siphatha ama-reagents ethu.
Ukucatshangelwa Kokulawula
I-reagents yethu isekela ukuhambisana ne-FDA (21 CRR ingxenye 210/1211), EMA (European Medicies Medicies Agency), kanye ne-ICH (Umkhandlu Womhlaba Wonke
Ngenkathi ama-kits ethu engeyona i-FDA - evunyelwe ukusetshenziswa kwemitholampilo, basiza ekuhlangabezaneni nezimfanelo ezisezingeni eliphakeme (CQAS) ezidingekayo ekutholeni okulawulwayo.
Ukuphepha nokusingathwa
Onke ama-reagents aphethwe amandla ekhwalithi aqinile (qc) ukuqinisekisa ukusebenza kanye nokuvela kabusha.
Izimo Zokugcina Ezifanele Nezinqubo Zokuphatha kufanele zilandelwe njengoba kuchaziwe kumadokhumenti womkhiqizo.
Abasebenzisi kufanele babheke amashidi wedatha yokuphepha ngokwezinto ezibonakalayo (MSDS) yemihlahlandlela yengozi nokulahla.
Ukuzibophezela Kwamakhasimende
Amakhasimende abhekene nalokhu:
Iqinisekisa ama-reagents ethu ngezinhlelo zawo ezithile.
Ukuqinisekisa ukuhambisana nemithetho yendawo yokuhlolwa komkhiqizo we-Cell Therapy.
Kusetshenziswa imikhiqizo yethu ngezinhloso zabo zokucwaninga okuhlosiwe.
Ngeminye imininingwane, sicela ubheke kuma-Manuals ethu womkhiqizo noma uthinte iqembu lethu lokusekelwa kwezobuchwepheshe ku-Bluekitbio@hillgene.com.
I-Bluekitbio - Ucwaningo lwe-Cell Therapy Research ngokunemba nokuhambisana
Isikhathi Sokuposa: 2025 - 05 - 26 14:25:27
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