Ulwazi Lomkhiqizo
Umshini wokuqapha wokuthola amaqoqo we-TVS wenza izinkomba zekhwalithi zethebhulethi kanye nokusebenza komshini wokucindezela ithebhulethi kuqashelwe eduze nangempumelelo ngaso sonke isikhathi, ukuze kutholwe izinkinga ngesikhathi, ukuqaphela ngokushesha nokuhlukanisa izingxenye zomkhiqizo eziyingozi.Umshini wokuthola ukuqapha wamaqoqo I-TVS yenza ukuqapha okukude endaweni yokukhiqiza, ukuqonda kwesikhathi sangempela salokho okwenzeka endaweni yokukhiqiza, kanye nezindlebe ze-clairance nezindlebe zomhubhe womoya zokukhiqiza kanye nabasebenzi bokuphatha ikhwalithi.
Njengesethi yesistimu yokulawula ikhwalithi enamandla, umshini wokuqapha wokuthola ama-batches we-TVS ukulawulwa kwenqubo yekhwalithi yokukhiqiza ithebhulethi, ithuluzi elinamandla lokuthola izinkinga kwasekuqaleni nokusiza abasebenzi bokukhiqiza ukuthi bathole izinkinga ngokushesha, ithuluzi lokuqalisa eliphumelelayo lekhwalithi ye-SPC. umqondo wokuphatha, kanye nesiqinisekiso esisebenzayo sekhwalithi yomkhiqizo.
Inani kubasebenzisi
1. Umshini wokuqapha wokuthola ama-batches we-TVS uxhunywe nomshini wokugcwalisa i-capsule kanye nomshini wokucindezela ithebhulethi, isampula ngokungapheli ngokuvumelana nesikhathi esimisiwe, ingagadwa amahora angu-24 ngosuku, isisindo se-capsule nethebhulethi ngeke kubonakale kungavamile, ngoba uma uvela. okungajwayelekile, kuzotholakala ngokushesha, i-CVS izoba yi-alamu ukukhumbuza, futhi ngasikhathi sinye, kunezingozi zezingxenye zomkhiqizo zahlukaniswa ngokushesha, ziqashwe eduze i-CVS emahoreni angama-24, kungakhathaliseki ukuthi ikhwalithi yomkhiqizo, noma isimo semishini yokukhiqiza esebenzayo, konke kusesimweni esilawulekayo, hhayi inkinga.
2. Yonke idatha yesisindo sokusanhlamvu yethebhulethi iyiqiniso futhi inokwethenjelwa, futhi imininingwane yezibalo inemininingwane futhi irekhodwe unomphela, ingakwazi ukubuza ingaphrinta, irekhodi lokuhlola isampula lesisindo sokusanhlamvu eliphrintiwe ephepheni linolwazi oluphelele kanye nedatha enemininingwane, ingaba ngokuqondile njenge amarekhodi okukhiqiza iqoqo, ububi bokukalwa kwesampula okwenziwa ngesandla nokurekhoda kuyakhululwa, kunciphise kakhulu umfutho womsebenzi womsebenzisi, kwenza ukulawulwa kwekhwalithi yomuthi kube ngaphezulu esinyathelweni esisha.
3. Ngokuphathelene nesikhathi kanye nokusebenza ngempumelelo kokulawulwa nokulawula ubungozi, ukutholwa kwamaqoqo kanye nomsebenzi wokuhlukanisa wokuqapha umshini wokuthola amaqoqo we-TVS, kunganciphisa ubungozi bobubanzi bufinyelele ezingeni eliphansi, kungehlisa udoti wezinto ezibonakalayo ezingeni eliphansi.
4. Mayelana nokuhambisana, umshini wokuqapha ohlonza amaqoqo we-TVS uhlangabezana nezimfuneko eziphakeme kakhulu ze-cGMP ne-GMAP5, ithobela ngokuqinile yonke imithetho ye-US FDA 21CFR-PART11, ihlangabezana nazo zonke izimfuneko zobuqotho bedatha, futhi idatha ye-elekthronikhi ilungele ukulandeleka kwekhwalithi futhi ukulandelela ukuhlolwa.
5. Umshini wokubona wokuqapha wamaqoqo Imisebenzi enamandla ye-TVS kanye nokuqapha okukude kwenza ukukhiqizwa nokuphathwa kwekhwalithi kube lula futhi kuphumelele.I-CVS ayilona nje ithuluzi elisebenzayo lokuthuthukisa ikhwalithi kanye nokulawula inqubo yezibalo ye-SPC yekhwalithi yezidakamizwa, kodwa futhi iyindawo edingekayo yezingxenyekazi zekhompiyutha ukuze amabhizinisi athuthukise ukukhiqiza futhi afeze imihlangano yokucobelelana ngolwazi yokwenziwa nengenamuntu.
Thumela umlayezo wakho kithi:
Isikhathi sokuthumela: Sep-03-2020