21 CFR Pharma yog dab tsi?
21 CFR Pharma yog dab tsi?

Video: 21 CFR Pharma yog dab tsi?

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

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