UShicilelo lweMveliso yeThebhulethi eSebenza ngokuNinzi kwi-Intanethi yokuBeka iliso kwi-Intanethi yeeBatshi zeTVS

Ulwazi lweMveliso

Ukubeka iliso umatshini wokubona iibhetshi ze-TVS zenza ukuba izikhombisi zekhwalithi zethebhulethi kunye nokusebenza komatshini wokushicilela ithebhulethi zibekwe esweni ngokusondeleyo nangempumelelo ngamaxesha onke, ukufumanisa iingxaki ngexesha, qaphela ngokukhawuleza kwaye uhlukanise amacandelo emveliso enobungozi.Ukubeka iliso kumatshini wokubona iibhetshi ze-TVS zenza ukuba kubekwe iliso kude kwindawo yokuvelisa, ukuqonda kwangexesha lokwenyani okwenzekayo kwindawo yokuvelisa, kunye nombono we-clairance kunye neendlebe zomoya zokuvelisa kunye nabasebenzi bolawulo lomgangatho.

Njengeseti yenkqubo yokulawula umgangatho onamandla, umshini wokukhangela ukukhangela iibhetshi ze-TVS yinkqubo yokulawula umgangatho wokuvelisa ithebhulethi, isixhobo esinamandla sokufumana iingxaki kwindawo yokuqala kunye nokunceda abasebenzi bokuvelisa ukuba bafumane iingxaki ngokukhawuleza, isixhobo esisebenzayo sokuphunyezwa komgangatho we-SPC. ingqiqo yolawulo, kunye nesiqinisekiso esisebenzayo somgangatho wemveliso.

Ixabiso kubasebenzisi

1. Ukubeka iliso umatshini wokubona iibhetshi ze-TVS ziqhagamshelwe kumatshini wokuzalisa i-capsule kunye nomatshini wokushicilela wethebhulethi, isampula ngokungapheliyo ngokwexesha elicwangcisiweyo, inokubekwa iliso kwiiyure ezingama-24 ngosuku, ubunzima be-capsule kunye nethebhulethi abuyi kubonakala bungaqhelekanga, kuba emva kokuvela. engaqhelekanga, iya kufunyanwa ngoko nangoko, CVS iya alarm ukukhumbuza, kwaye kwangaxeshanye, kukho imingcipheko amacandelo imveliso ngokukhawuleza bodwa, ngoko esweni ngocoselelo CVS kwiiyure ezingama-24, nokuba umgangatho imveliso, okanye isixhobo imveliso esebenzayo isimo, zonke zikwimeko elawulekayo, hayi ingxaki.

2. Yonke idatha yobunzima bengqolowa yethebhulethi iyinyani kwaye ithembekile, kwaye ulwazi lweenkcukacha-manani luneenkcukacha kwaye lurekhodwe ngokusisigxina, unokubuza unokuprinta, irekhodi yovavanyo lwesampula yobunzima bengqolowa eprintwe ephepheni inolwazi olubanzi kunye nedatha eneenkcukacha, ingaba ngokuthe ngqo njengoko iirekhodi ibhetshi imveliso, nezingeloncedo iisampulu manual ukuweyisha kunye nokurekhodwa baxolelwe, kuncitshiswe kakhulu ugxininiso labasebenzi bomqhubi, ukwenza ulawulo umgangatho ichiza ngakumbi kwinyathelo elitsha.

3. Ngokubhekiselele kwixesha kunye nokusebenza kokulawulwa komngcipheko kunye nokulawula, ukufunyanwa kweebhetshi kunye nomsebenzi wokuzihlukanisa wokujonga umshini wokukhangela iibhetshi ze-TVS, unokunciphisa umngcipheko we-scope ukuya kwinqanaba elincinci, unokunciphisa inkunkuma yezinto eziphathekayo kwinqanaba elincinci.

4. Ngokuhambelana nokuthotyelwa, ukukhangela umatshini wokukhangela iibhetshi i-TVS ihlangabezana neemfuno eziphezulu ze-cGMP kunye ne-GMAP5, ithobela ngokungqongqo yonke imimiselo ye-US FDA 21CFR-PART11, ihlangabezana nazo zonke iimfuno zengqibelelo yedatha, kunye nedatha ye-elektroniki ilungele ukulandelwa komgangatho kunye ukulandelwa kophicotho.

5. Ukubeka iliso umatshini wokubona iibhetshi imisebenzi enamandla ye-TVS kunye nokubeka iliso kude kwenza imveliso kunye nolawulo lomgangatho lube lula kwaye lusebenze.I-CVS ayisosixhobo esisebenzayo kuphela sokuphucula umgangatho kunye nokuqonda inkqubo yeenkcukacha-manani ye-SPC yomgangatho wamachiza, kodwa ikwayindawo eyimfuneko yezixhobo zokusebenza kumashishini okuphucula ukwenziwa kunye nokufezekisa iindibano zocweyo ezenziweyo nezingenamntu.

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