Ahumahi rongoā - he aha te hononga nui atu i te patu huakita me te whakahoromata

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Nō nā tata nei, i tirotirohia, i whakahaerea hoki tētahi kamupene rongoā e ngā mana whakahaere e tika ana nā runga i ngā tūponotanga mōrearea haumaru i roto i te pūnaha whakahaere kounga, ā, i akiakihia te kamupene rongoā kia whakamutua tonutia te hanga hei whakatikatika, ā, i tangohia hoki te tiwhikete "rongoā GMP" taketake a te kamupene.

I te marama o Hepetema 2020, i tukuna e te FDA (US Food and Drug Administration) tētahi reta whakatūpato mō tētahi kamupene rongoā patu huakita i Inia. I whakatūpato nui te reta kāore te kamupene i tino whakatinana i ngā tikanga manatoko horoi paerewa i te wā e whakaputa ana i te rongoā hou, engari i arotahi ki te whakakorenga ōkawa o ngā huakita, ka arahi atu ki te mōrearea o ētahi atu poke o te pānga horoi me te kore e wātea te kounga o ngā rongoā kua hangaia. Kua whakamanahia. Nō reira, kua whakapumautia kāore te FDA e whakaae kia uru te rongoā ki te mākete kaihoko i te United States kia whakaūtia rā anō ka taea e te kamupene te whakapai ake i ngā raruraru e pā ana.

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Ina tirohia ngā take e rua i runga ake nei, kotahi te mea e rite ana me kukume i te aro o te umanga, arā, ko te raruraru o te hononga manatoko horoi kāore anō kia whakatauhia marietia, ā, kāore hoki e tutuki i ngā whakaritenga tiwhikete mana. Arā, ko te horoi te mea nui ki te whakatau i te haumaru o te rongoā, ā, e pā ana ki te tukanga katoa o te rongoā.

Ina hoki, nā te whakatinanatanga o te putanga hou o te GMP (Good Manufacturing Practice), kua piki ake ngā whakaritenga mō ngā kamupene rongoā e pā ana ki te whakahaere kounga rongoā, inā koa i ngā āhuatanga motuhake o te R&D, te whakaputa, te whakahaere kounga, me te kawe waka.

Mō tētahi kamupene rongoā, he kaupapa here ā-motu te GMP. Ko ngā kamupene e kore e whakataurite, e pupuri rānei i te GMP i roto i te wā kua whakaritea, ka whiua ki ngā taumata rerekē, tae atu ki ngā whakatūpato me te whakamutu i te whakaputanga. He tukanga tino uaua te whakarite kia tutuki te kounga o ngā rongoā i te paerewa tika. I roto i ēnei, ko te horoi tetahi o ngā tohu nui hei ine mēnā he pumau te kaha whakaputa a ngā kamupene rongoā. He maha ngā kamupene rongoā kāore i whakaaetia kia haere tonu te whakaputanga i muri i te tirotiro a ngā tari e tika ana. Ko te take matua ko te hononga matua - kāore ngā taputapu horoi i te ma. Ina koa, ko ngā taputapu taiwhanga i hangaia ki te karāhe, te kirihou, me ētahi atu. Kāore e taea te whakarite kia horoia pai ngā paru toenga.

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He mea tika kia whakanuia i tēnei wā, he maha ngā kamupene rongoā e aro ana ki te patu huakita me te whakahoromata, engari kāore e aro ki tētahi atu mahi nui ake, arā, te manatoko horoi. He mārama he hē tēnei māramatanga. E mōhio ana koe, ko ngā taipitopito nui o te manatoko horoi me uru atu hoki ki te patu huakita me te whakahoromata me te horoi pai o te taiwhanga o te kamupene rongoā. Mai i tētahi tirohanga, he mea nui ake te mea whakamutunga i te mea o mua. Ko te take, ko te tukanga manatoko horoi e kapi ana i te wāhanga whakawhanake tikanga, te wāhanga whakarite kaupapa, te wāhanga whakatinanatanga kaupapa, me te wāhanga tiaki mana manatoko. Ko ēnei wāhanga e whā e whakahaerehia ana i runga i te kaupapa matua o te GMP, arā, me pēhea te "whakaiti i te parahanga me te whakawhiti-parahanga i roto i te tukanga whakaputa rongoā". I ia wāhanga o te hononga manatoko whakamātautau, kāore e taea te wehe atu i te paerewa horoi karāhe hei whakaritenga mō te whiwhi hua tika, whai hua me te pono o te kimi me te tātari.

Ehara i te mea kāore e taea te kore e hiahia ngā taiwhanga o ngā kamupene e tika ana ki te whakapai ake i te raruraru horoi o ngā taputapu me te whakarei ake i te pānga horoi - he nui noa te whakapai ake me te whakakapi i te tikanga horoi ā-ringa taketake ki tētahi pūnaha horoi aunoa. Hei tauira, ko te whakaurunga me te whakamahinga o tētahihoroi karaihe aunoako tētahi o ngā otinga pai rawa atu.

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Tehoroi karaihe aunoahe tikanga horoi rehu. Ka taea te tihore i ngā toenga i runga i te mata o te taonga mā te wai wera me te hinu whakahinuhinu hei whakamakuku i ngā matū toenga, kia ma ai, kia kanapa ai anō te taonga. Mā te whakamahi i te rerenga wai pēhanga teitei mai i te ringa rehu me te anga kete, kaMīhini Horoi TaiwhangaKa taea te tuku tika i te rere o te wai mā roto i te rohe horoi o roto mā te papu horoi e rere ana ki tetahi kokonga o te ūnga horoi. Ina haere te wai mā roto i te whakamahana hei hanga i te pāmahana teitei, ā, ka whakamahia hei pou wai, ka taea te horoi pai i ngā toenga parahanga e piri ana ki te tihi o te oko tango, ā, ka tutuki ai te kaupapa o te horoi me te whakamaroke. Ehara i te mea koira anake, ko te whakamahinga o te pūnaha horoi aunoa mō teHoroi Taiwhangahe tino pai te horoi (horoi karaihe aunoa(te mahi puranga, te tukanga horoi auau), te tere pakaru iti o te pounamu (te whakarerekētanga urutau ki te pēhanga rere wai, te pāmahana o roto, me ētahi atu), me te whānuitanga o ngā mahi (Ka taea te whakauru i ngā ngongo whakamātautau, ngā rihi petri, ngā ipu rōrahi, ngā ipu kōniko, ngā rango ine, me ētahi atu o ngā rahi me ngā āhua rerekē, ā, he whakahaere atamai te tukanga katoa, he haumaru, he pono hoki (he paipa whakauru wai haumaru ātete-pahū kawemai kua tāutahia, he ātete ki te pēhanga me te pāmahana, kāore e ngāwari ki te here. He paru, me te takirere aroturuki ārai- turuturu, ka kati aunoa te taputapu ina pakaru te takirere solenoid). Hei tāpiri, ko tehoroi karaihe taiwhangaKa taea te whakaatu tonu i ngā raraunga nui pēnei i te kawe hiko, te TOC, te kukū hinu, me ētahi atu, he mea watea mō ngā kaimahi e tika ana ki te aroturuki me te whakahaere i te ahunga whakamua o te horoi me te hono i te pūnaha ki te tā me te tiaki he tino whai hua, e whakarato ana i te watea mō te whai i muri mai.

Mīhini Horoi TaiwhangaKa āwhina i ngā kamupene rongoā ki te whakaiti i te whakaputanga o te poke whakawhiti, ka āwhina ki te whakarite kia pai ake te hononga o ia hononga o te manatoko horoi a te kamupene rongoā, ā, ka āwhina hoki i ngā kamupene rongoā ki te whakapai ake i te taumata whānui o te tono taputapu. E tutuki katoa ana i ngā whakaritenga ture i whakatakotoria e te GMP i roto i ngā whenua maha. He mea tika kia tirohia, kia whakamahia hoki e te nuinga o ngā kamupene rongoā.

 


Wā tuku: Maehe-15-2021