haki_whārangi

Ngā Pūrongo

Kua Whiwhi Tiwhikete FDA te Pūnaha Whakahaere LN₂ a Haier Biomedical

1 (1)

Nō nā tata nei, i whakamanahia e te TÜV SÜD China Group (e kiia nei i muri nei ko "TÜV SÜD") ngā tuhinga hiko me ngā waitohu hiko o te pūnaha whakahaere hauota wai a Haier Biomedical i runga anō i ngā whakaritenga o te FDA 21 CFR Wāhanga 11. Tekau mā ono ngā otinga hua, i whakawhanakehia motuhaketia e Haier Biomedical, i whakawhiwhia ki te pūrongo tutuki ture a TÜV SÜD, tae atu ki te raupapa Smartand Biobank.

Mā te whiwhi tiwhikete FDA 21 CFR Wāhanga 11, ka tutuki ngā tuhinga hiko me ngā waitohu o te pūnaha whakahaere LN₂ o Haier Biomedical i ngā paerewa o te pono, te ngākau pono, te noho muna me te whai i ngā raraunga, ā, mā reira ka whakarite i te kounga me te haumarutanga o ngā raraunga. Mā tēnei ka tere ake te whakamahi i ngā otinga pūnaha rokiroki hauota wai i roto i ngā mākete pēnei i te US me te Ūropi, hei tautoko i te whānui haere o Haier Biomedical ki te ao whānui.

1 (2)

I te whiwhinga i te tiwhikete FDA, kua tīmata te pūnaha whakahaere hauota wai a HB i tētahi haerenga hou o te ao whānui

Ko TÜV SÜD, he kaiārahi o te ao mō te whakamātautau me te tiwhikete a te hunga tuatoru, e aro tonu ana ki te whakarato tautoko ture ngaio puta noa i ngā ahumahi, hei āwhina i ngā umanga kia noho mataara ki ngā ture e whanake haere ana. Ko te paerewa FDA 21 CFR Wāhanga 11 i whakaputaina e te US Food and Drug Administration (FDA), e tuku ana i ngā tuhinga hiko te mana ture ōrite ki ngā tuhinga me ngā waitohu tuhituhi, e whakarite ana i te mana me te pono o ngā raraunga hiko. E pā ana tēnei paerewa ki ngā whakahaere e whakamahi ana i ngā tuhinga me ngā waitohu hiko i roto i ngā rongoā koiora, ngā taputapu hauora, me ngā ahumahi kai.

Mai i tōna whakaputanga, kua whānuitia te whakamahi i te paerewa puta noa i te ao, ehara i te mea ko ngā kamupene rongoā koiora o Amerika anake, ngā hōhipera, ngā whare rangahau, me ngā taiwhanga, engari ko Ūropi me Āhia anō hoki. Mō ngā kamupene e whakawhirinaki ana ki ngā tuhinga hiko me ngā waitohu, he mea nui te tutuki i ngā whakaritenga o te FDA 21 CFR Wāhanga 11 mō te whanaketanga pumau o te ao, me te whakarite kia tutuki i ngā ture FDA me ngā paerewa hauora me te haumaru e tika ana.

Ko te pūnaha whakahaere hauota wai CryoBio a Haier Biomedical he "roro mohio" mō ngā ipu hauota wai. Ka hurihia e ia ngā rauemi tauira hei rauemi raraunga, me te maha o ngā raraunga e aroturukitia ana, e tuhia ana, e rongoatia ana i te wā tūturu, e whakatūpato ana i ngā hapa. Kei roto hoki he ine takirua motuhake o te pāmahana me ngā taumata wai, me te whakahaere hierarki o ngā mahi a ngā kaimahi. Hei tāpiri, ka whakaratohia hoki he whakahaere tirohanga o ngā tauira hei urunga tere. Ka taea e ngā kaiwhakamahi te huri i waenga i ngā aratau ā-ringa, āhua-hau, me te āhua-wai mā te pāwhiri kotahi, ka whakapai ake i te whai huatanga. Hei tāpiri, ka hono te pūnaha ki te tūāpapa mōhiohio tauira IoT me te BIMS, ka taea ai te hononga maeneene i waenga i ngā kaimahi, ngā taputapu, me ngā tauira. Ka whakaratohia e tēnei he wheako rokiroki pāmahana tino iti pūtaiao, paerewa, haumaru, me te whai hua.

Kua whakawhanakehia e Haier Biomedical tētahi otinga rokiroki hauota wai kotahi-mutunga whānui e tika ana mō ngā whakaaturanga me ngā wāhanga rōrahi katoa, e arotahi ana ki ngā whakaritenga kanorau o te whakahaere rokiroki tauira cryogenic. Ka hipokina e te otinga ngā āhuatanga maha, tae atu ki te rongoā, te taiwhanga, te rokiroki pāmahana-iti, ngā raupapa koiora, me ngā raupapa kawe koiora, ā, ka whakaratohia ki ngā kaiwhakamahi he wheako tukanga katoa tae atu ki te hoahoa hangarau, te rokiroki tauira, te tiki tauira, te kawe tauira, me te whakahaere tauira.

1 (5)

Mā te tutuki i ngā paerewa FDA 21 CFR Wāhanga 11, kua whakamanahia te pūnaha whakahaere hauota wai CryoBio a Haier Biomedical mō te mana o ā mātou waitohu hiko me te pono o ā mātou tuhinga hiko. Nā tēnei tiwhikete tutuki i ngā whakaritenga kua whakarei ake i te whakataetae matua a Haier Biomedical i roto i te mara o ngā otinga rokiroki hauota wai, me te whakatere i te whānui o te waitohu i ngā mākete o te ao.

Whakateretere i te panonitanga o te ao hei kukume i ngā kaiwhakamahi, hei whakapai ake hoki i te whakataetae o ngā mākete o te ao

Kua piri tonu a Haier Biomedical ki tētahi rautaki ā-ao, e whakatairanga tonu ana i tētahi pūnaha takirua "whatunga + tauwāhi". I taua wā anō, kei te whakapakari tonu mātou i te whanaketanga o ngā pūnaha mākete hei aro atu ki ngā kaiwhakamahi, me te whakarei ake i ā mātou otinga horopaki i roto i te taunekeneke, te whakaritenga, me te tuku.

Me te arotahi ki te waihanga i te wheako kaiwhakamahi pai rawa atu, ka whakapakari a Haier Biomedical i te rohe mā te whakatū i ngā tīma me ngā pūnaha ā-rohe hei whakautu wawe i ngā hiahia o ngā kaiwhakamahi. I te mutunga o te tau 2023, kua riro i a Haier Biomedical tētahi whatunga tohatoha ki tāwāhi neke atu i te 800 ngā hoa mahi, ā, kua mahi tahi me te neke atu i te 500 ngā kaiwhakarato ratonga muri-hoko. I taua wā, kua whakatūria e mātou he pūnaha pokapū wheako me te whakangungu, e arotahi ana ki te United Arab Emirates, Nigeria me te United Kingdom, me tētahi pūnaha pokapū putunga me te whakahaere taonga kei roto i te Netherlands me te United States. Kua whakawhānui ake mātou i tā mātou rohe ki te UK, ā, kua āta tāruatia tēnei tauira puta noa i te ao, me te whakapakari tonu i tā mātou pūnaha mākete ki tāwāhi.

Kei te tere ake hoki te whakawhānui ake a Haier Biomedical i ngā hua hou, tae atu ki ngā taputapu taiwhanga, ngā taonga pau, me ngā whare rongoā atamai, e whakarei ake ana i te whakataetae o ā mātou otinga horopaki. Mō ngā kaiwhakamahi pūtaiao ora, kua angitu ā mātou miihini whakapūmau i roto i a Ūropi me Amerika, kua whiwhi ā mātou whakamaroke tio i ngā ota tuatahi i Āhia, ā, kua uru atu ā mātou kāpata haumaru koiora ki te mākete rawhiti o Ūropi. I taua wā, kua tutuki ā mātou taonga pau taiwhanga, ā, kua tāruatia ki Āhia, Amerika Te Raki, me Ūropi. Mō ngā whare hauora, haunga ngā otinga kano ārai mate pūngao rā, kei te tere haere hoki te whanaketanga o ngā pouaka whakamātao rongoā, ngā waeine rokiroki toto, me ngā taonga pau. Mā te taunekeneke tonu me ngā whakahaere o te ao, ka whakarato a Haier Biomedical i ngā ratonga tae atu ki te hanganga taiwhanga, te whakamātautau taiao me te whakahoromata, ka waihanga i ngā whai wāhitanga tipu hou.

I te mutunga o te tau 2023, neke atu i te 400 ngā tauira Haier Biomedical kua whakamanahia ki tāwāhi, ā, kua tukuna angitu ki ētahi kaupapa nui i Zimbabwe, te Democratic Republic of Congo, Etiopia, me Liberia, tae atu ki te kaupapa China-Africa Union Centers of Disease Control (CDC), e whakaatu ana i te whakapainga o te mahi tuku. Kua whānuitia te whakamahi i ā mātou hua me ngā otinga i roto i te neke atu i te 150 whenua me ngā rohe. I taua wā anō, kua mau tonu tā mātou mahi tahi mō te wā roa me te neke atu i te 60 ngā whakahaere o te ao, tae atu ki te World Health Organization (WHO) me te UNICEF.

He tohu nui te whiwhi tiwhikete FDA 21 CFR Wāhanga 11 mō Haier Biomedical i a mātou e arotahi ana ki te auahatanga i roto i tā mātou haerenga whānui o te ao. E whakaatu ana hoki i tā mātou whakapau kaha ki te whakatutuki i ngā hiahia o ngā kaiwhakamahi mā te auahatanga. I te tirohanga whakamua, ka haere tonu a Haier Biomedical i tā mātou huarahi auahatanga e aro ana ki te kaiwhakamahi, me te whakatairanga i tā mātou whakatinanatanga rautaki ā-ao puta noa i ngā rohe, ngā hongere, me ngā kāwai hua. Mā te whakanui i te auahatanga ā-rohe, ko tā mātou whāinga he tūhura i ngā mākete o te ao mā te matauranga.


Te wā tuku: Hurae-15-2024