FDA Regulations
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Mayelana nalolu hlelo lokusebenza
Lolu hlelo lokusebenza iqukethe okuqukethwe egcwele United States Food and Drug Administration (FDA) Ukudla, Kudivayisi Medical and Drug GMP Regulations. Okulandelayo Isihloko 21 Izingxenye afakiwe:
21CFR4: Olawula Inhlanganisela Imikhiqizo
21CFR11: Electronic Amarekhodi: Kusayina Electronic
21CFR108: Emergency Permit Control
21CFR110: yamanje Okuhle Ukukhiqiza Kwentiwa Ukukhiqiza, Packing noma Holding Ukudla Human
21CFR111: yamanje Okuhle Ukukhiqiza Kwentiwa Ukukhiqiza, Icubungula, Packing noma Holding yokusebenza zokudla nezithasiselo
21CFR113: Thermally Okwenziwe okuphansi-Acid Ukudla Oluphakhejiwe e Iziqukathi Hermetically afakwe ezimvilophini
21CFR114: Ukudla acidified
21CFR117: yamanje Good Ukukhiqiza Practice, Hazard Ukuhlaziywa, futhi Izingozi Isekelwe Izilawuli Zokuzivikela for Ukudla Human
21CFR120: Hazard Analysis ezibucayi yokulawula (HACCP) Systems
21CFR123: Inhlanzi Nezokudoba Imikhiqizo
21CFR210: yamanje Okuhle Ukukhiqiza Kwentiwa Ukukhiqiza, Icubungula, Packing, noma Holding kwezidakamizwa; Jikelele
21CFR211: yamanje Okuhle Ukukhiqiza Practice for Okwemithi Finished
21CFR801: Labelling
21CFR803: Ukubikwa Kudivayisi Medical
21CFR806: Med Amadivayisi; Imibiko Ukulungisa & Ukwesulwa
21CFR807: Ukusungulwa Registration
21CFR809: kwesibeletho Yokucwaninga Imikhiqizo
21CFR812: Ukukhululwa Kudivayisi Investigational
21CFR814: Premarket Ukugunyazwa Medical Devices
21CFR820: Quality System Regulation
21CFR821: Kudivayisi Medical Tracking Izidingo
21CFR822: Postmarket Surveillance
21CFR830: Ukukhomba Kudivayisi abahlukile
21CFR860: Ukwahlukanisa Izinqubo
I-FDA Ukudla, izidakamizwa, neziqondiso Kudivayisi Medical kuthiwa behlukana yisigaba, chofoza ingxenye ukuze sandise ukuthi isigaba othize. Chofoza ukuze ufihle. Ingxenye ngayinye iqukethe isixhumanisi website FDA equkethe ukulawulwa ukuze uqinisekise ukuthi isesikhathini samanje.
Imithethonqubo FDA zigcinwa kudivayisi yakho futhi asidingi uxhumano lwe-inthanethi ukufinyelela.
Lolu hlelo lokusebenza ewusizo for mabhuku futhi ngokuthi kukhulunywa jikelele, nje ugcine ifoni yakho Ukugunda esikhundleni ethwele liyincwadi reference.
21CFR4: Olawula Inhlanganisela Imikhiqizo
21CFR11: Electronic Amarekhodi: Kusayina Electronic
21CFR108: Emergency Permit Control
21CFR110: yamanje Okuhle Ukukhiqiza Kwentiwa Ukukhiqiza, Packing noma Holding Ukudla Human
21CFR111: yamanje Okuhle Ukukhiqiza Kwentiwa Ukukhiqiza, Icubungula, Packing noma Holding yokusebenza zokudla nezithasiselo
21CFR113: Thermally Okwenziwe okuphansi-Acid Ukudla Oluphakhejiwe e Iziqukathi Hermetically afakwe ezimvilophini
21CFR114: Ukudla acidified
21CFR117: yamanje Good Ukukhiqiza Practice, Hazard Ukuhlaziywa, futhi Izingozi Isekelwe Izilawuli Zokuzivikela for Ukudla Human
21CFR120: Hazard Analysis ezibucayi yokulawula (HACCP) Systems
21CFR123: Inhlanzi Nezokudoba Imikhiqizo
21CFR210: yamanje Okuhle Ukukhiqiza Kwentiwa Ukukhiqiza, Icubungula, Packing, noma Holding kwezidakamizwa; Jikelele
21CFR211: yamanje Okuhle Ukukhiqiza Practice for Okwemithi Finished
21CFR801: Labelling
21CFR803: Ukubikwa Kudivayisi Medical
21CFR806: Med Amadivayisi; Imibiko Ukulungisa & Ukwesulwa
21CFR807: Ukusungulwa Registration
21CFR809: kwesibeletho Yokucwaninga Imikhiqizo
21CFR812: Ukukhululwa Kudivayisi Investigational
21CFR814: Premarket Ukugunyazwa Medical Devices
21CFR820: Quality System Regulation
21CFR821: Kudivayisi Medical Tracking Izidingo
21CFR822: Postmarket Surveillance
21CFR830: Ukukhomba Kudivayisi abahlukile
21CFR860: Ukwahlukanisa Izinqubo
I-FDA Ukudla, izidakamizwa, neziqondiso Kudivayisi Medical kuthiwa behlukana yisigaba, chofoza ingxenye ukuze sandise ukuthi isigaba othize. Chofoza ukuze ufihle. Ingxenye ngayinye iqukethe isixhumanisi website FDA equkethe ukulawulwa ukuze uqinisekise ukuthi isesikhathini samanje.
Imithethonqubo FDA zigcinwa kudivayisi yakho futhi asidingi uxhumano lwe-inthanethi ukufinyelela.
Lolu hlelo lokusebenza ewusizo for mabhuku futhi ngokuthi kukhulunywa jikelele, nje ugcine ifoni yakho Ukugunda esikhundleni ethwele liyincwadi reference.
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Ukuphepha kuqala ngokuqonda ukuthi onjiniyela baqoqa futhi babelane kanjani ngedatha yakho. Ubumfihlo bedatha nezinqubo zokuphepha zingahluka kuye ngokusebenzisa kwakho, isifunda, nobudala. Unjiniyela unikeze lolu lwazi futhi angalubuyekeza ngokuhamba kwesikhathi.
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