Cov ntaub ntawv khoom
Kev soj ntsuam xyuas lub tshuab rau cov khoom siv TVS ua rau cov ntsuas zoo ntawm cov ntsiav tshuaj thiab kev ua haujlwm ntawm cov ntsiav tshuaj xovxwm tshuab kom zoo thiab saib xyuas txhua lub sijhawm, txhawm rau txheeb xyuas cov teeb meem hauv lub sijhawm, ceeb toom tam sim thiab cais cov khoom pheej hmoo.Kev soj ntsuam xyuas lub tshuab rau cov khoom siv TVS ua rau kev saib xyuas cov chaw taws teeb ntawm qhov chaw tsim khoom, kev nkag siab ntawm lub sijhawm tiag tiag ntawm qhov chaw tsim khoom, thiab clairance-vision thiab cua-tunnel pob ntseg rau kev tsim khoom thiab kev tswj xyuas cov neeg ua haujlwm zoo.
Raws li cov txheej txheem tswj hwm kev tswj hwm muaj zog, kev soj ntsuam xyuas lub tshuab rau cov khoom siv TVS yog cov txheej txheem tswj cov ntsiav tshuaj ntau lawm, lub cuab yeej muaj zog los nrhiav cov teeb meem hauv thawj qhov chaw thiab pab cov neeg ua haujlwm tsim khoom kom pom cov teeb meem sai, cov cuab yeej siv tau zoo ntawm SPC zoo. tswj lub tswv yim, thiab kev lav zoo rau cov khoom zoo.
Tus nqi rau cov neeg siv
1. Kev soj ntsuam xyuas lub tshuab rau cov khoom siv TVS txuas nrog lub tshuab capsule filling tshuab thiab ntsiav tshuaj xovxwm tshuab, sampling tsis tu ncua raws li lub sijhawm teem sijhawm, tuaj yeem saib xyuas 24 teev hauv ib hnub, qhov hnyav ntawm cov tshuaj ntsiav thiab ntsiav tshuaj yuav tsis tshwm sim txawv txav, vim tias ib zaug tshwm sim. txawv txav, nws yuav pom tam sim ntawd, CVS yuav ceeb toom, thiab tib lub sijhawm, muaj kev pheej hmoo ntawm cov khoom lag luam raug cais tawm tam sim ntawd, yog li saib xyuas CVS hauv 24 teev, seb cov khoom lag luam zoo li cas, lossis cov khoom siv ntau lawm, tag nrho hauv lub xeev tswj tau, tsis muaj teeb meem.
2. Tag nrho cov ntaub ntawv hnyav hnyav ntawm cov ntsiav tshuaj yog qhov tseeb thiab txhim khu kev qha, thiab cov ntaub ntawv txheeb cais yog cov ncauj lus kom ntxaws thiab kaw mus tas li, tuaj yeem nug tuaj yeem luam tawm, cov qauv kuaj cov ntaub ntawv ntawm cov nplej hnyav luam tawm ntawm daim ntawv muaj cov ntaub ntawv ntxaws thiab cov ntaub ntawv ntxaws, tuaj yeem ncaj qha raws li batch ntau lawm cov ntaub ntawv, qhov tsis zoo ntawm phau ntawv sampling hnyav thiab cov ntaubntawv povthawj siv tau raug zam, txo tus neeg teb xov tooj kev siv zog ua haujlwm, ua rau cov tshuaj tswj tau zoo dua ntawm cov kauj ruam tshiab.
3. Raws li lub sij hawm thiab kev ua tau zoo ntawm kev pheej hmoo thiab kev tswj xyuas, kev tshawb nrhiav rau cov khoom siv thiab kev cais tawm ntawm kev soj ntsuam xyuas lub tshuab rau batches TVS, tuaj yeem txo qhov kev pheej hmoo ntawm kev ua haujlwm mus rau qib qis, tuaj yeem txo cov khoom pov tseg mus rau qib qis.
4. Nyob rau hauv cov nqe lus ntawm kev ua raws, kev soj ntsuam xyuas lub tshuab rau batch TVS ua tau raws li qhov siab tshaj plaws ntawm cGMP thiab GMAP5, nruj me ntsis raws li tag nrho cov kev cai ntawm US FDA 21CFR-PART11, ua tau raws li tag nrho cov kev cai ntawm cov ntaub ntawv kev ncaj ncees, thiab cov ntaub ntawv hluav taws xob yog yooj yim rau traceability zoo thiab tshawb nrhiav.
5. Kev soj ntsuam xyuas lub tshuab rau batch TVS lub zog muaj zog thiab kev saib xyuas tej thaj chaw deb ua rau kev tsim khoom thiab kev tswj xyuas zoo dua yooj yim thiab siv tau zoo.CVS tsis yog tsuas yog cov cuab yeej siv tau los txhim kho qhov zoo thiab paub txog SPC cov txheej txheem kev tswj hwm ntawm cov tshuaj zoo, tab sis kuj yog ib qho khoom siv tsim nyog rau cov lag luam txhawm rau txhim kho kev tsim khoom thiab paub txog cov khoom siv dag zog thiab tsis muaj neeg ua haujlwm.
Xa koj cov lus rau peb:
Post lub sij hawm: Sep-03-2020