CFR hauv FDA yog dab tsi?
CFR hauv FDA yog dab tsi?

Video: CFR hauv FDA yog dab tsi?

Video: CFR hauv FDA yog dab tsi?
Video: 21 CFR! FDA США! Базовые знания. # 21CFR # ФАРМАЦЕВТИЧЕСКАЯ ПРОМЫШЛЕННОСТЬ # USFDA # 21CFR ЧАСТЬ 211. 2024, Kaum ib hlis
Anonim

Txoj Cai ntawm Tsoom Fwv Teb Chaws Txoj Cai ( CFR ) yog ib codification ntawm cov kev cai dav dav thiab mus tas li luam tawm nyob rau hauv Tsoom Fwv Teb Chaws Register los ntawm lub Executive departments thiab cov koom haum ntawm tsoom fwv.. Title 21 ntawm lub CFR yog tseg rau cov cai ntawm Food and Drug Administration.

Ib yam li ntawd, tshooj twg ntawm 21 CFR muaj cov cai los ntawm FDA?

Title 21 CFR Nws Part 11 yog ib feem ntawm Title 21 ntawm Code of Federal Kev cai uas tsim tsa Tsoomfwv Meskas Cov Khoom Noj thiab Tshuaj ( FDA ) cov kev cai ntawm cov ntaub ntawv hluav taws xob thiab kos npe hluav taws xob (ERES).

Ib yam li ntawd, muaj pes tsawg feem muaj nyob hauv 21 CFR? Nws muaj peb tshooj, txhua qhov tshwj xeeb hauv cov lej rau cov koom haum no. 21 CFR Nws feem ntau paub txog 21 cfr ib ntu 11 hluav taws xob kos npe. Tab sis nws muaj qhov sib txawv cov muaj txawv cov txheej txheem yuav tsum tau ua raws li kev lag luam.

Yog li ntawd, CFR yog dab tsi hauv kev sim tshuaj?

CFR - Code of Federal Regulations - Txoj Cai Federal Regulations ( CFR ) yog cov kev cai luam tawm los ntawm tsoomfwv cov koomhaum, suav nrog FDA. Cov npe tshwj xeeb hauv lub CFR siv rau Zoo kho mob Xyaum hauv kho mob kev tshawb fawb, suav nrog: 21 CFR Tshooj 812 (Kev Tshawb Fawb Cov Cuab Yeej Exemption)

FDA txhais li cas ntawm cov cuab yeej kho mob?

A khoom siv kho mob yog txhais Tsis pub dhau lub Food Drug & Cosmetic Act li "ib qho cuab yeej, cuab yeej, siv, tshuab, contrivance, implant, in vitro reagent, los yog lwm yam zoo sib xws los yog cov tshooj lus, nrog rau ib feem, los yog accessory uas yog: lees paub nyob rau hauv lub official National Formulary, los yog Tebchaws Meskas

Pom zoo: