I-CDMO eqinisekisiwe ngekhwalithi

Ihambisana nazo zonke izidingo zokulawula ze-FDA GMP

kufaka phakathi 21 CFR Ingxenye 210, 21 CFR Ingxenye 211, kanye 21 CFR Ingxenye 11.

Inkampani ithi akukho okukhishiwe ku-21 CFR Ingxenye 820, 201, 211, 11

Umkhiqizi Wenkontileka Yemithi Ukubhaliswa kwe-FDA # 3015266446

Ukuqinisekisa ikhwalithi

I-T&T Scientific Departments of Quality Assurance kanye Nokulawula Ikhwalithi Iqinisekisa Ikhwalithi Yemikhiqizo Yakho Yezidakamizwa, Ukukhishwa Kweqoqo, Nokulethwa ukuze Kuthobelane Namazinga Aphakeme Nemithethonqubo


Compliance

Umnyango ngamunye uyiyunithi yokusebenza ehlukene yenhlangano, futhi indlela yekhwalithi eyisisekelo iwumongo wakho konke esikwenzayo lapha. Ukusebenza Kwekhwalithi Ye-T&T kulawulwa yisizindalwazi Imanuwali Yekhwalithi. I-T&T Scientific Corporation's Quality Management System ithatha ukuqondisa kwayo kokuthi 21 CFR Ingxenye 820 Quality System Regulations futhi ithobela zonke izimfuneko zokulawula ze-FDA GMP ezihlanganisa 21 CFR Ingxenye 210, 21 CFR Ingxenye 211, kanye 21 CFR Ingxenye 11. Inkampani ayifuni okushiyelwa ngaphandle kokuthi 21 CFR Ingxenye 820, 201, 211, 11 ku-7140 Regal Lane, Knoxville, TN 37918.


I-Electronic Quality Management System (eQMS): Qualio

Ngemva kokwenziwa kwesiphakamiso, ithimba lephrojekthi liyakhethwa futhi izibopho zabelwe isofthiwe yokuphatha iphrojekthi ye-T&T (ngoMsombuluko.com) kanye nohlelo lokuphathwa kwekhwalithi kagesi lwe-T&T (eQMS), i-Qualio. Ukuhlolwa kwezingozi nezinkinga ezingaba khona ezihlobene nokudluliswa komkhiqizo kuyadingeka ukuze kukhonjwe, kuhlolwe, futhi kusethwe izenzo zemisebenzi yokunciphisa ubungozi. Le nqubo yokuhlola ubungozi ibuswa yinqubo futhi ibhalwe kusetshenziswa isifanekiso se-FMEA salokhu kuhlola. Lokhu kuhlola kufanele kubhekane nanoma yimiphi imithelela engaba khona kuphothifoliyo yamanje, ukuthobela umthetho, ikhwalithi, ukuphepha, njll. Ukubuyekezwa kokuqala kwezingozi ezingaba khona zokungcoliswa okuhambisana nokwethulwa kwezinto ezintsha zokusetshenziswa kanye nama-API abuyekezwa ukuze kuphathwe okukhethekile nokucatshangelwa kwamasampula. Izingozi ezingaba khona zokunukubezeka okuphambanayo okuhlotshaniswa nokwethulwa kwezinto zokusetshenziswa ezintsha nama-API ziyabuyekezwa. Ukuhlola kugxile, kulezi zinhlobo ezilandelayo zemikhiqizo/izinto ezisetshenziswayo: i-cytotoxicity, ama-antibiotics, imikhiqizo yamaseli, njll. Lokhu kuhlola ubungozi kuzofakwa ekulawuleni izinguquko ezihambisana nephrojekthi.

Inqubomgomo Yekhwalithi

1) Gqugquzela umqondo wekhwalithi okhuthaza uthando lokuthuthuka okuqhubekayo. 2) Qinisekisa ukuthobela zonke izimfuneko zokulawula ezisebenzayo. 3) Qinisekisa imikhiqizo ephephile nesebenzayo namasevisi agcwalisa izidingo zamakhasimende.


Ikhwalithi yokulawula

I-T&T Scientific enososayensi abaqashelwa kakhulu emhlabeni wonke kanye nezinqubo eziqinile zokulawula ikhwalithi, eholwa uDkt. Drishti Sehgal, iqinisekisa ikhwalithi yemikhiqizo eshiya inhlangano isezingeni eliphezulu kakhulu lekhwalithi futhi iyahambisana nezindinganiso nemithetho.


Umlando Wokuhlola

I-T&T ibhaliswe ne-FDA, ireferensi yokubhaliswa kwe-FDA # 3015266446. Amasistimu wekhwalithi we-T&T, ama-SOP, izinqubomgomo, nengqalasizinda ihambisana nezidingo zokulawula ze-FDA, EMA, kanye ne-JP ukuze kuthuthukiswe futhi kwenziwe umkhiqizo wezidakamizwa ukuze kusekelwe izivivinyo zangaphambi Komtholampilo kanye Nezomtholampilo. Bonke abangaba amakhasimende bayamenywa ukuba beze bavakashele indawo yethu futhi benze ucwaningo oluvumela inkontileka. Kutuswa kakhulu ukwenza kanjalo. Ivumela womabili amaqembu ukuthi aqale ukwakha ubuhlobo futhi aqonde kangcono imisebenzi yethu. Kodwa-ke, uma kubhekwa ubhubhane kanye nokunye ukuncishiswa kwesikhathi, siyabona ukuthi lokhu akwenzeki ngaso sonke isikhathi. Ngonyaka odlule, samukela ukucwaningwa kwamabhuku okubonakalayo okuningana ngokuqhuba ukuvakasha okubonakalayo, izingxoxo ze-Zoom, nokubuyekezwa kwemibhalo. Ukucwaningwa kwamabhuku okugcina okwenziwa endaweni kube wucwaningomabhuku losuku olulodwa nesigamu olwenziwa ngomhlaka-01-Mar-21 yikhasimende laphesheya kwezilwandle elangena esivumelwaneni sangaphambi komtholampilo/iSigaba soku-1 sokuthuthukisa kanye nokukhiqiza ngemuva kwalokho. Ukucwaninga kubuyekeze lonke uhlelo lwekhwalithi, kanye nezinqubo ze-aseptic fill/finish. Iqoqo lokuqala Lomtholampilo lihlelelwe ukuthi ligcwaliswe ngoSepthemba 2021.

Ngobukhona bekhwalithi obuqinile ezitezi zokukhiqiza, sikwazile ukuhlinzeka ngempumelelo ngezinto ezidingekayo zokugcwalisa i-IND kuzo zombili izimakethe zase-US nezamazwe ngamazwe.


I-T&T Scientific ibeka imikhiqizo yayo nekhwalithi yezinsizakalo phakathi nokusebenza kwayo ukuze iqinisekise
ukuphepha kwabasebenzisi neziguli ezisebenzisa imikhiqizo namasevisi e-T&T Scientific,
kanye nokwenza lula inqubo yamakhasimende ayo yokugunyaza i-FDA