Nkwenye & oke mma
A na-emepụta ngwa ịchọpụta anyị n'okpuru ISO 13485: 2016 mmachi nhazi nlekọta, na-ejide agbanwe agbanwe, ntụkwasị obi na traceability. Anyị na-agbaso ezigbo ihe omume na-emepụta (GMP) ebe ọdabara, na-ekwe nkwa na ndị na-agụ akwụkwọ anyị zutere uru ụlọ ọrụ ụlọ ọrụ kachasị elu.
Ebumnuche & adịghị ike
Ngwaahịa anyị bụ maka nyocha iji naanị (REO) na ekwesighi iji ya na nyocha nke ụlọ ọgwụ ma ọ bụ ọgwụgwọ mmadụ.
Ha kachasị mma maka njirimara ngwaahịa ngwaahịa, ule nchekwa nchekwa, na nleba anya.
Ndị ọrụ ga-agbaso Protocols na ntuziaka kacha mma mgbe ha na-ejizi ihe ndị ọzọ.
Nyocha nyocha
Ndị na-eme ihe ubi anyị na-akwado nkwado na FDA (21 cfr Part 210/211), EMA Mediction), na Ich International Parcilines maka Cell na-anwale.
Ọ bụ ezie na ngwa anyị abụghị FDA - Akwa maka ụlọ ọgwụ, ha na-enyere aka na nzukọ dị oke mkpa (CQAS) chọrọ maka ntinye aha.
Nchekwa & njikwa
Ihe ndị na-agụru ihe niile na-eme ka ọ dị mma mma (QC) iji hụ na arụmọrụ na ịmụ nwa.
A ga-agbaso ọnọdụ nchekwa zuru oke na usoro a ga-enwerịrị akọwapụtara na akwụkwọ ederede.
Ndị ọrụ kwesịrị izo aka na mpempe akwụkwọ nchekwa ihe onwunwe (MSDs) maka ihe ọghọm na nduhie.
Ibu ọrụ ndị ahịa
Ndị ahịa na-ahụ maka:
Nkwado ndị na-agụ akwụkwọ maka ngwa ha.
Iji nwee nnabata na usoro iwu obodo maka nnwale nke cell.
Iji ngwaahịa anyị naanị maka ebumnuche nyocha ha.
Maka nkọwa ndị ọzọ, biko rụtụ aka na akwụkwọ ntuziaka ngwaahịa anyị ma ọ bụ kpọtụrụ ndị ọrụ nkwado nke teknụzụ anyị na Bluekitbio@hillgene.com.
Bluekitbio - Nyochaa Cell Cell na nkenke & nnabata
Oge post: 2025 - 05 - 26 14:25:25:25:25
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