Ukubhaliswa kwe-FDA kwezimonyo kusho ukubhaliswa kwezinkampani ezithengisa izimonyo e-United States ngokuvumelana nezimfuneko ze-Federal Food and Drug Administration (FDA) ukuze kuqinisekiswe ukuphepha komkhiqizo nokuhambisana. Ukubhaliswa kwe-FDA kwezimonyo kuhlose ukuvikela impilo nokuphepha kwabathengi, ngakho-ke, kubalulekile ezinkampanini ezifuna ukuthengisa izimonyo emakethe yase-US ukuthi ziqonde ukuthi zibhaliswa kanjani izimonyo ne-FDA kanye nezinto okufanele zinakwe.
I-FDA iyisikhungo esiphezulu sokulawula e-United States esinomthwalo wemfanelo wokuqinisekisa ukuphepha, ukusebenza kahle, kanye nekhwalithi yezimonyo. Ububanzi bayo bokulawula buhlanganisa kodwa alikhawulelwe kufomula, izithako, ukulebula, inqubo yokukhiqiza, nokukhangisa kwezimonyo. Inhloso ye-FDA yezimonyo ukuvikela impilo yomphakathi namalungelo, iqinisekisa ukuthi izimonyo ezithengiswa emakethe zithobela imithetho nezindinganiso ezifanele.
Izidingo zokufaka isicelo sokubhaliswa kwe-FDA kanye nesitifiketi sezimonyo zifaka lezi zici ezilandelayo:
1. Isimemezelo sesithako: Isicelo sokubhaliswa kwe-FDA kanye nesitifiketi sezimonyo sidinga ukuthunyelwa kwesimemezelo sesithako somkhiqizo, okuhlanganisa zonke izithako ezisebenzayo, odayi, amakha, njll. Lezi zithako kufanele zibe semthethweni futhi zingabi yingozi emzimbeni womuntu.
2. Isitatimende sokuphepha: Isicelo sokubhaliswa kwe-FDA kanye nesitifiketi sezimonyo sidinga ukuthunyelwa kwesitatimende sokuphepha somkhiqizo, esifakazela ukuthi umkhiqizo uphephile ngaphansi kwezimo ezijwayelekile zokusebenzisa. Lesi sitatimende sidinga ukusekelwe ocwaningweni lwesayensi nedatha.
3. Isitatimende silebula: Isicelo sokubhaliswa kwe-FDA kanye nesitifiketi sezimonyo sidinga ukuthunyelwa kwesitatimende selebula somkhiqizo, okuhlanganisa igama lomkhiqizo, ulwazi lomkhiqizi, imiyalelo yokusetshenziswa, njll. Ilebula kufanele icace, ibe mfushane, futhi ingadukisi abathengi.
4. Ukuthobela inqubo yokukhiqiza: Isicelo sokubhaliswa kwe-FDA kanye nesitifiketi sezimonyo sidinga ubufakazi bokuthi inqubo yokukhiqiza umkhiqizo ithobelana nemithetho ye-FDA, okuhlanganisa okokusebenza kokukhiqiza, izimo zokuhlanzeka, ukulawulwa kwekhwalithi, nezinye izici.
5. Ukufakwa kwesicelo: Isicelo sokubhaliswa kwe-FDA nesitifiketi sezimonyo sidinga ukuthunyelwa ngohlelo lwe-inthanethi lwe-FDA, futhi imali yokufaka isicelo iyahlukahluka kuye ngohlobo nokuba yinkimbinkimbi komkhiqizo.
Ukubhaliswa kwe-FDA
Inqubo yokubhalisa ye-Cosmetic FDA
1. Qonda imithetho nemigomo efanele
Ngaphambi kokubhalisa izimonyo ne-FDA, izinkampani zidinga ukuqonda imithetho nemibandela efanelekile ye-FDA yezimonyo, okuhlanganisa nemithetho yokulebula yezimonyo, imithetho yokulebula yesithako, njll. Le mithetho nemigomo icacisa izidingo zezithako, ukulebula, nokuphepha kwezimonyo. ukuqinisekisa ukuthobela nokuphepha komkhiqizo.
2. Lungiselela imibhalo yokubhalisa
Ukubhaliswa kwe-FDA yezimonyo kudinga ukuthunyelwa kochungechunge lwezinto zokubhalisa, okuhlanganisa ulwazi oluyisisekelo lwenkampani, ulwazi lomkhiqizo, uhlu lwezithako, imiyalelo yokusetshenziswa, njll., ukuze kuboniswane nokuhlolwa kwe-Beston. Amabhizinisi adinga ukulungiselela lezi zinto kusenesikhathi futhi aqinisekise ubuqiniso bazo nokuphelela.
3. Thumela isicelo sokubhalisa
Amabhizinisi angabhalisa izimonyo ne-FDA ngokusebenzisa isizindalwazi sikagesi se-FDA noma izicelo zephepha. Lapho uthumela isicelo, izimali zokubhalisa ezihambisanayo zidinga ukukhokhwa.
4. Buyekeza kanye Nokuvunywa
I-FDA izobuyekeza izinto zokubhalisa ezithunyelwe, okuhlanganisa ukuqashelwa kohlu lwesithako somkhiqizo nemiyalelo yokusetshenziswa, ukubuyekezwa kwamalebula omkhiqizo nemiyalelo yokusebenza, njll. Uma ukubuyekezwa kuvunyiwe, i-FDA izokhipha isitifiketi sokubhalisa futhi imemezele ukubhaliswa okuyimpumelelo umkhiqizo ne-FDA. Uma ukubuyekezwa kuhluleka, ukuguqulwa nokuthuthukiswa kudinga ukwenziwa ngokuya ngempendulo evela ku-FDA, futhi isicelo sidinga ukuthunyelwa kabusha.
Ilebhu yokuhlola ye-BTF, inkampani yethu inamalabhorethri ahambisana nogesi, izimiso zokuphepha Ilabhorethri, Ilabhorethri yefrikhwensi yomsakazo, Ilabhorethri yebhethri, Ilabhorethri yamakhemikhali, I-SAR Laboratory, I-HAC Laboratory, njll. Sithole iziqu nokugunyazwa okufana ne-CMA, CNAS, CPSC, A2LA, I-VCCI, njll. Inkampani yethu inethimba lobunjiniyela bezobuchwepheshe abanolwazi nochwepheshe, elingasiza amabhizinisi ukuxazulula inkinga. Uma unezidingo ezifanele zokuhlola nezitifiketi, ungathintana ngqo nabasebenzi bethu bokuhlola ukuze uthole amakhotheshini anemininingwane yezindleko kanye nolwazi lomjikelezo!
Umbiko wokuhlola we-FDA
Isikhathi sokuthumela: Aug-28-2024
