Video: Dab tsi yog Qhov Zoo los ntawm Tsim FDA?
2024 Tus sau: Stanley Ellington | [email protected]. Kawg hloov kho: 2023-12-16 00:17
Txhais. Tshuaj Zoo los ntawm Tsim (QbD) yog txheej txheem kev txhim kho uas pib nrog lub hom phiaj ua ntej thiab hais txog cov khoom lag luam thiab txheej txheem kev nkag siab thiab kev tswj hwm, raws li kev tshawb fawb suab thiab zoo kev tswj hwm kev pheej hmoo.
Ntxiv mus, vim li cas Kev Tsim Kho Zoo Tsim nyog?
Zoo los ntawm Tsim yog lub tswv yim, txheej txheem txheej txheem kom tau txais koj cov khoom lag luam tshiab mus rau kev lag luam sai dua, yooj yim dua, rau tsawg dua. Quality los ntawm Design's tseem ceeb rau kev tshawb fawb zoo, kev tswj xyuas cov laj thawj thiab kev tswj hwm kev pheej hmoo tsis tu ncua nrawm lub sijhawm rau kev ua lag luam, txo cov nqi thiab nce kev vam meej.
Ib tus tseem yuav nug, RLD hauv QbD yog dab tsi? Cov RLD yog qhov tso tawm tam sim (IR) ntsiav tshuaj qhia rau kev kho mob ntawm cov tsos mob ntawm lub cev mus rau qhov hnyav. Peb siv Quality by Design ( QbD ) los tsim cov generic acetriptan IR ntsiav tshuaj uas kho tau zoo sib npaug RLD.
Tsuas yog li ntawd, qhov zoo tsim TQM yog dab tsi?
Zoo ntawm tsim yog txhais raws li qhov haum ntawm cov khoom (kev pabcuam) tsim thiab cov neeg siv khoom xav tau; zoo ntawm kev ua raws tau txhais raws li qhov haum ntawm tus yam ntxwv ntawm cov khoom lag luam tiag tiag thiab nws qhov tshwj xeeb. Txhawm rau kom txaus siab rau cov neeg siv khoom, zoo yuav tsum siab ntawm ob qhov ntev.
Qhov chaw tsim hauv QbD yog dab tsi?
Tsim Chaw hauv QbD - Cov lus txhais. Rau tus kws tshawb fawb, Tsim Chaw yog Y (Cov Qauv Zoo) = F (Cov Txheej Txheem Txheej Txheem, Cov Qauv Khoom) - muaj nuj nqi lossis kev sib raug zoo ntawm (qhov tseem ceeb) txheej txheem txheej txheem thiab (tseem ceeb) cov yam ntxwv zoo /cov khoom siv.
Pom zoo:
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