Ukubhaliswa kwe-FDA yezithambiso kubhekiselele ekubhalisweni kweenkampani ezithengisa izimonyo e-United States ngokuhambelana neemfuno ze-Federal Food and Drug Administration (FDA) ukuqinisekisa ukhuseleko lwemveliso kunye nokuthotyelwa. Ubhaliso lwe-FDA lwezithambiso lujolise ekukhuseleni impilo kunye nokhuseleko lwabathengi, ngoko ke, kubalulekile kwiinkampani ezifuna ukuthengisa izimonyo kwiimarike zase-US ukuba ziqonde indlela yokubhalisa izithambiso kunye ne-FDA kunye nezinto ekufuneka zihoywe.
I-FDA lelona nqanaba liphezulu le-arhente yolawulo e-United States enoxanduva lokuqinisekisa ukhuseleko, ukusebenza kakuhle, kunye nomgangatho wezithambiso. Umda wayo wokulawula ubandakanya kodwa awukhawulelwanga kwifomula, izithako, ukuleyibhile, inkqubo yokuvelisa, kunye nentengiso yezithambiso. Injongo ye-FDA yezimonyo kukukhusela impilo yoluntu kunye namalungelo, ukuqinisekisa ukuba izimonyo ezithengiswa kwiimarike zihambelana nemimiselo kunye nemigangatho efanelekileyo.
Iimfuno zokufaka isicelo sobhaliso lwe-FDA kunye nesiqinisekiso sezinto zokuthambisa ziquka le miba ilandelayo:
1. Isibhengezo sesithako: Isicelo sokubhaliswa kwe-FDA kunye nokuqinisekiswa kwezithambiso kufuna ukungeniswa kwesibhengezo sesithako semveliso, kubandakanywa zonke izithako ezisebenzayo, idayi, iziqhumiso, njl. Ezi zithako kufuneka zibe semthethweni kwaye zingabi yingozi kumzimba womntu.
2. Isiteyitimenti soKhuseleko: Isicelo sokubhaliswa kwe-FDA kunye nokuqinisekiswa kwezithambiso kufuna ukuhanjiswa kwengxelo yokhuseleko kwimveliso, ebonisa ukuba imveliso ikhuselekile phantsi kweemeko zokusetyenziswa eziqhelekileyo. Le nkcazo kufuneka isekelwe kwimifuniselo yenzululwazi kunye nedatha.
3. Isiteyitimenti seleyibhile: Isicelo sokubhaliswa kwe-FDA kunye nesiqinisekiso sezinto zokuthambisa sifuna ukungeniswa kwengxelo yeleyibhile yemveliso, kubandakanywa igama lemveliso, ulwazi lomenzi, imiyalelo yokusetyenziswa, njl. njl. abathengi.
4. Ukuthotyelwa kwenkqubo yokuvelisa: Isicelo sokubhaliswa kwe-FDA kunye nokuqinisekiswa kwezithambiso kufuna ubungqina bokuba inkqubo yokuvelisa imveliso ihambelana nemimiselo ye-FDA, kubandakanywa nezixhobo zokuvelisa, iimeko zokucoceka, ukulawula umgangatho, kunye nezinye iinkalo.
5. Ukufakwa kwesicelo: Ukubhaliswa kwe-FDA kunye nesicelo sesiqinisekiso sezinto zokuthambisa kufuneka singeniswe ngenkqubo yesicelo se-intanethi ye-FDA, kwaye umrhumo wesicelo uyahluka ngokuxhomekeka kuhlobo kunye nobunzima bemveliso.
Ukubhaliswa kwe-FDA
Inkqubo yobhaliso ye-Cosmetic FDA
1. Ukuqonda imigaqo kunye nemigangatho efanelekileyo
Ngaphambi kokubhalisa izithambiso kunye ne-FDA, iinkampani kufuneka ziqonde imimiselo efanelekileyo kunye nemigangatho ye-FDA yezinto zokuthambisa, kubandakanywa nemigaqo yokubhala izithambiso, imimiselo yokulebula izithako, njl. ukuqinisekisa ukuthotyelwa kwemveliso kunye nokhuseleko.
2. Lungiselela amaxwebhu obhaliso
Ukubhaliswa kwe-Cosmetics ye-FDA kufuna ukungeniswa koluhlu lwezixhobo zokubhalisa, kubandakanya ulwazi olusisiseko lwenkampani, ulwazi lwemveliso, uluhlu lwezithako, imiyalelo yokusetyenziswa, njl., Ukubonisana no-Beston Testing. Amashishini kufuneka alungiselele ezi mathiriyeli kwangaphambili kwaye aqinisekise ubunyani bazo kunye nokugqibelela.
3. Ngenisa isicelo sobhaliso
Amashishini anokubhalisa izinto zokuthambisa kwi-FDA ngokusebenzisa uvimba weenkcukacha wombane we-FDA okanye izicelo zephepha. Xa ufaka isicelo, kufuneka kuhlawulwe iifizi zobhaliso ezihambelanayo.
4. Uphononongo kunye nokuvunywa
I-FDA iya kuphonononga izinto zokubhalisa ezifakiweyo, kubandakanywa ukuqaphela uluhlu lwesithako semveliso kunye nemiyalelo yokusetyenziswa, ukuphononongwa kweelebhile zemveliso kunye nemiyalelo yokusebenza, njl. Ukuba uphononongo luvunyiwe, i-FDA iya kukhupha isatifikethi sokubhalisa kwaye ibhengeze ukubhaliswa ngempumelelo imveliso kunye ne-FDA. Ukuba ukuphononongwa akuphumeleli, ukuguqulwa kunye nokuphuculwa kufuneka kwenziwe ngokwengxelo evela kwi-FDA, kwaye isicelo kufuneka sithunyelwe kwakhona.
ILebhu yoVavanyo lwe-BTF, inkampani yethu ineelabhoratri ezihambelana ne-electromagnetic, imimiselo yokhuseleko kwiLebhu, iLebhu yerediyo engenazingcingo, iLebhu yebhetri, iLebhu yeekhemikhali, iLabhoratri yeSAR, iLabhoratri ye-HAC, njl. njl. Inkampani yethu inamava kunye neqela lobuchwephesha lobuchwephesha lobuchwephesha, elinokunceda amashishini ukusombulula ingxaki. Ukuba unovavanyo olufanelekileyo kunye neemfuno zesatifikethi, ungaqhagamshelana ngokuthe ngqo nabasebenzi bethu boVavanyo ukuze ufumane iikowuti zeendleko ezineenkcukacha kunye nolwazi lomjikelo!
Ingxelo yovavanyo lwe-FDA
Ixesha lokuposa: Aug-28-2024
