Video: 21 CFR Pharma yog dab tsi?
2024 Tus sau: Stanley Ellington | [email protected]. Kawg hloov kho: 2023-12-16 00:17
21 CFR thiab Nws Cov Lus Pom Zoo. Title 21 ntawm CFR los yog Txoj Cai Tswjfwm Ntiag Tug hais txog kev tswj hwm cov zaub mov thiab tshuaj hauv Tebchaws Meskas rau peb ntawm nws lub koomhaum tswjfwm: FDA (Food and Drug Administration), DEA (Drug Enforcement Agency) thiab ONDCP (Office of National Drug Control Policy).
Tsis tas li ntawd, vim li cas peb thiaj muaj 21 CFR?
Los ntawm kev qhia cov 21 CFR Tshooj 11 txoj cai, FDA muaj Qhov tseem ceeb ua rau lub neej Science hauv zej zog thiab lwm yam FDA tswj kev lag luam txhawm rau txhim kho cov txheej txheem kev lag luam, txo cov sij hawm hloov pauv thiab cov nqi, tag nrho los ntawm kev tsim cov txheej txheem rau kev siv cov ntaub ntawv hluav taws xob thiab kos npe.
Ib yam li ntawd, Usfda yog dab tsi hauv pharma? Food and Drug Administration (FDA los yog USFDA ) yog ib lub koom haum tseem ceeb ntawm Tebchaws Meskas Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv thiab Kev Pabcuam Tib Neeg, yog ib lub koomhaum tseemfwv hauv tebchaws Meskas.
Ib yam li ntawd, 21 CFR part 11 siv rau dab tsi?
21 CFR Part 11 siv rau cov ntaub ntawv hauv electronic form yog tsim, hloov kho, khaws cia, khaws cia, khaws cia, thiab / lossis xa tawm raws li cov ntaub ntawv xav tau los ntawm FDA.
Muaj pes tsawg feem muaj nyob rau hauv 21 CFR?
Nws muaj peb tshooj, txhua qhov tshwj xeeb hauv cov lej rau cov koom haum no. 21 CFR feem ntau paub txog 21 cfr ib part 11 electronic signature. Tab sis nws muaj txawv qhov chaw cov muaj txawv cov txheej txheem yuav tsum tau ua raws li kev lag luam.
Pom zoo:
FDA CFR 21 yog dab tsi?
Title 21 yog ib feem ntawm Txoj Cai Tswjfwm Txoj Cai Tswjfwm zaub mov thiab tshuaj hauv Tebchaws Meskas rau Food and Drug Administration (FDA), Lub Chaw Saib Xyuas Tshuaj Yeeb Tshuaj (DEA), thiab Office of National Drug Control Policy (ONDCP)
Dab tsi yog CTA hauv Pharma?
Kev Pom Zoo Kev Kho Mob (CTA); (IND) Cov txheej txheem suav nrog kev tau txais tus lej EudraCT los ntawm European Medicines Agency (EMA) thiab xa daim ntawv thov rau Clinical Trial Authorization (CTA) mus rau Lub Tuam Txhab Muaj Peev Xwm ntawm txhua lub xeev uas qhov kev sim yuav ua
CFR hauv FDA yog dab tsi?
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 Sau Npe los ntawm Cov Thawj Coj thiab cov koom haum ntawm Tsoom Fwv Teb Chaws.. Title 21 ntawm CFR yog tshwj tseg rau cov cai ntawm Food and Drug Administration
Qhov txawv ntawm CFR thiab CNF yog dab tsi?
C&F, CNF lossis CFR txhais tau tias Tus Nqi & Freight. Ntawm no, tus nqi muag khoom ntawm kev muag khoom suav nrog tus nqi thiab freight ntawm cov khoom. Kuv yuav piav qhia txog CFR (tseem hu ua CNF thiab C&F) cov ntsiab lus ntawm kev xa khoom nrog piv txwv yooj yim. Kev tuav pov hwm ntawm cov khoom tau ntsib los ntawm tus neeg yuav khoom hauv caseof C&F kev lag luam
Dab tsi yog rabs hauv pharma?
RABS lossis C-RABS (Closed RABS) yog ib hom kev txwv tsis pub nkag mus rau kev ua haujlwm aseptic ntawm cov khoom siv tshuaj uas txo lossis tshem tawm cov kev cuam tshuam rau hauv cheeb tsam tseem ceeb muab: unidirectional air flow systems (kom ncav cuag chav kawm A ib puag ncig rau thaj chaw tseem ceeb) ;