Txoj Kev Ua Raws Li Txoj Cai: Kev Sau Npe Thoob Ntiaj Teb, Cov Txheej Txheem Zoo thiab Kev Cai Hloov Kho

Cov kws kho mob cov kws kho mob ua haujlwm nyob rau hauv lub ntiaj teb cov kev tswj hwm nruj tshaj plaws, qhov uas muaj peev xwm ua raws cai ncaj qha txiav txim siab txog kev tsim nyog rau kev lag luam. Qhov nyuaj ntawm kev sau npe thoob ntiaj teb yog daunting. Rau cov tshuaj tiv thaiv kev nyab xeeb tshiab kom nkag mus rau Asmeskas kev lag luam, cov tuam txhab yuav tsum ua kom tiav daim ntawv thov FDA 510 (k) lossis PMA, uas yuav siv sijhawm nruab nrab ntawm 18-24 lub hlis thiab raug nqi $ 1.5-3 lab. Ua raws li kev ua raws li EU MDR Txoj Cai (2017/745), cov ntaub ntawv tsim nyog tau nce los ntawm 300 nplooj ntawv yav dhau los mus rau ntau dua 1,000 nplooj ntawv, thiab kev soj ntsuam kev soj ntsuam yuav tsum suav nrog cov ntaub ntawv siv hauv ntiaj teb tiag. Tuam Tshoj tus NMPA txais yuav txoj kev sau npe peb pawg; Cov koob tshuaj tiv thaiv kev nyab xeeb tshiab yog feem ntau cais raws li Class III cov cuab yeej kho mob, yuav tsum muaj tsawg kawg ntawm 300 qhov kev sim tshuaj ntsuam xyuas hauv Suav teb. Nyiv PMDA muaj npe nrov rau nws cov kev tshuaj xyuas nruj, ua haujlwm "kev tshuaj xyuas qhov chaw tsim khoom ua ntej, tom qab ntawd tshuaj xyuas cov ntaub ntawv kev" qauv uas tau ua rau ntau lub tuam txhab txawv teb chaws. Cov tuam txhab lag luam saum toj kawg nkaus xws li BD tuav lub koom haum thoob ntiaj teb kev tswj hwm kev ua haujlwm ntawm ntau dua 200 tus kws tshaj lij, taug qab kev tswj hwm kev hloov kho thoob plaws ntau dua 50 lub khw tseem ceeb hauv lub sijhawm, nrog rau lawv cov ntaub ntawv tswj hwm vaj tsev nyob ntau dua 100,000 tus txheej txheem kev khiav haujlwm (SOPs).

Cov ntawv pov thawj zoo yog lub neej ntawm kev tsim khoom. ISO 13485 tsuas yog ua raws li cov hauv paus ntsiab lus; FDA's QSR 820 kev tswj hwm kev ua haujlwm zoo suav nrog 12 cov kab ke, ntawm cov Kev Tswj Xyuas Tsim (21 CFR 820.30) thiab Kev Kho thiab Tiv Thaiv Kev Ua Haujlwm (CAPA, 21 CFR 820.100) yog qhov tseem ceeb tshaj plaws. Thaum lub sij hawm soj ntsuam ntawm qhov chaw, FDA cov neeg tshawb xyuas tau txais "cov ntaub ntawv traceability mus kom ze", random rub batch ntaub ntawv ntawm ib rab koob ntau thiab taug qab tag nrho cov nqi saw los ntawm raw khoom mus rau cov khoom tiav; ib qho kev tawg ntawm kev taug qab tuaj yeem ua rau daim ntawv 483 kev soj ntsuam. EU ceeb toom lub cev kev tshuaj xyuas qhov tseem ceeb dua rau kev ua tau zoo ntawm kev tswj hwm kev pheej hmoo, xav kom cov tuam txhab ua kom pom tias "kev tswj hwm kev pheej hmoo ua raws li qib kev pheej hmoo ntawm kev pheej hmoo". Tuam Tshoj qhov tsis tau tshaj tawm GMP kev tshuaj xyuas tau ntev tuav tus nqi dhau qis dua 70%; Xyoo 2023, 12 lub tuam txhab cov koob txhaj tshuaj tau muab lawv cov ntawv pov thawj tshem tawm vim qhov tsis zoo ntawm kev ua kom tsis muaj menyuam. Cov tuam txhab ua lag luam tau teb los ntawm kev tsim cov "zoo kab lis kev cai", khi KPIs zoo rau cov thawj coj them nyiaj. BD's Zero Defect Initiative tau tsav lub Defective Parts Per Million (DPPM) tus nqi ntawm nws cov chaw tsim khoom tseem ceeb hauv qab 50, piv nrog kev lag luam nruab nrab ntawm 500-800.

Kev ua raws li tus qauv tsim yog ib qho kev cuam tshuam tseem ceeb. TS EN ISO 7864 Kev ntsuas cov txheej txheem rau rab koob taub hau ntse thiab nkag mus rau lub zog; TS EN ISO 9626 Kev tswj hwm qhov ntev ntev rau stainless-steel koob tubing; TS EN ISO 1135-4 Kev ntsuas ntshav sib xws. Qhov kev sib tw tiag tiag, txawm li cas los xij, nyob hauv cov qauv lag luam: tsis muaj cov qauv siv tau rau cov khoom lag luam tshiab xws li microneedle thaj ua rau thaj. Forward-thinking enterprises koom tes nyob rau hauv cov qauv-setting; Terumo rooj zaum ISO / TC 84, pawg kws tshaj lij rau kev txhaj tshuaj, txhais nws cov tswv yim kev daws teeb meem rau hauv cov qauv thoob ntiaj teb. Cov kev cai ib puag ncig kuj tau nce zuj zus ntxiv. EU MDR tswj hwm qhov kev pheej hmoo ntawm ib puag ncig los txheeb xyuas kev nyab xeeb ntawm phthalates, cov hlau hnyav thiab lwm yam khoom hauv cov khoom tiav; REACH Regulation's Substances of Very High Concern (SVHC) cov npe tam sim no suav nrog 223 yam khoom, ua kom tag nrho cov khoom siv-chain traceability yuav tsum tau ua.

Kev tswj hwm thev naus laus zis (RegTech) tab tom hloov kho thaj chaw sib tw. Blockchain ua kom tsis hloov pauv cov ntaub ntawv raw-cov ntaub ntawv traceability, tsim kom muaj cov ntaub ntawv tsis hloov pauv txuas ntxiv rau cov khoom siv steel hlau rau cov khoom tiav tiav. Artificial txawj ntse automates technical ntaub ntawv tshuaj xyuas, txheeb xyuas omissions thiab logical inconsistencies thiab txiav sau npe dossier lub sij hawm npaj los ntawm 40%. Digital ntxaib thev naus laus zis tsim cov chaw tsim khoom siv virtual los sim ua kom muaj peev xwm ua tsis tau raws li FDA kev tshuaj xyuas ntawm qhov chaw. Txawm li cas los xij, txoj cai sib txawv tseem muaj ntau. WHO Prequalification (PQ) ua lub rooj vag rau UN cov txheej txheem kev yuav khoom, tab sis nws cov txheej txheem tshuaj xyuas txawv ntawm FDA cov cai, yuam cov tuam txhab lag luam kom tswj hwm cov ntaub ntawv zoo sib xws. Cov kev taw qhia yav tom ntej taw qhia rau ntiaj teb kev tswj hwm kev sib haum xeeb. Yog tias International Medical Device Regulators Forum (IMDRF) tau ua tiav cov ntaub ntawv xa mus rau Cov Khoom Siv (RPS) nkaus xwb, cov nqi sau npe thoob ntiaj teb tuaj yeem poob los ntawm 30-50%, txawm hais tias cov xwm txheej geopolitical tseem ua rau qhov kev nce qib no qeeb.