Kubahiriza & ubuziranenge
Ibikoresho byacu byo gutahura byakorewe munsi ya ISO 13485: Sisitemu yubuyobozi bwa 2016, bugenga ubudahuzagurika, kwizerwa, no gukurikirana. Tubahiriza imikorere myiza yo gukora (GMP) aho bishoboka, yemeza ko reage zacu zihura nibipimo byinganda.
Igamije gukoresha & imbogamizi
Ibicuruzwa byacu ni ugukoresha ubushakashatsi gusa (Ruo) kandi ntigomba gukoreshwa mubuvuzi cyangwa kwivuza kwabantu.
Baringuriwe ibicuruzwa byo kuvura Akagari, kwipimisha umutekano, no gukurikirana inzira.
Abakoresha bagomba gukurikiza protocole ikwiye hamwe nubuyobozi bwa biosaft mugihe cyo gukora reagents.
Ibitekerezo byo kugenzura
Abayobozi bacu bashinzwe gushyigikira kubahiriza FDA (21 CFR igice cya 210/211), EMA (Imiti y'Iburayi y'abanyeshuri), na Ich (Inama mpuzamahanga yo guhuza ibicuruzwa no mu bicuruzwa.
Mugihe ibikoresho byacu ntabwo ari fda - Gufasha gukoresha amavuriro, bafasha muguhura nibiranga ubunebwe (CQAS) bisabwa kugirango bigerweho.
Umutekano & gutunganya
Reagents zose zirimo kugenzura ubuziranenge (QC) kugirango birebire imikorere no kubyara.
Imiterere ikwiye yo kubikamo nuburyo bwo gutunganya bigomba gukurikizwa nkuko bigaragara mubicuruzwa.
Abakoresha bagomba kwerekeza kumpapuro zumutekano wibintu (MSDS) kubiganiro byatewe na SAZAR NUBWO.
Inshingano z'abakiriya
Abakiriya bashinzwe:
Kwemeza reagents yacu kubisabwa byihariye.
Guharanira kubahiriza amabwiriza yaho kubizamini bya selile.
Gukoresha ibicuruzwa byacu gusa kubijyanye nubushakashatsi.
Kubindi bisobanuro, nyamuneka reba imfashanyigisho zacu cyangwa kuvugana nitsinda ryacu ryubururu kuri Bluekitbio@hillgene.com.
Bluekitbio - Guteza imbere Ubushakashatsi bwa Akagari hamwe no kubahiriza
Igihe cyagenwe: 2025 - 05 - 26:25:25
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