CDMO e netefalitsoeng ka boleng

E lumellana le litlhoko tsohle tsa taolo tsa FDA GMP
ho kenyelletsa 21 CFR Karolo ea 210, 21 CFR Karolo ea 211, le 21 CFR Karolo ea 11
Khamphani ha e re ha e qheleloe ka thoko ho karolo ea 21 CFR 820, 201, 211, 1.1
Pharmaceutical Contract Manufacturer FDA ngoliso # 3015266446
T&T has released several clinical batches in the US and internationally

CDMO e netefalitsoeng ka boleng

E lumellana le litlhoko tsohle tsa taolo tsa FDA GMP
ho kenyelletsa 21 CFR Karolo ea 210, 21 CFR Karolo ea 211, le 21 CFR Karolo ea 11
Khamphani ha e re ha e qheleloe ka thoko ho karolo ea 21 CFR 820, 201, 211, 1.1
Pharmaceutical Contract Manufacturer FDA ngoliso # 3015266446
T&T has released several clinical batches in the US and internationally

CDMO e netefalitsoeng ka boleng

E lumellana le litlhoko tsohle tsa taolo tsa FDA GMP
ho kenyelletsa 21 CFR Karolo ea 210, 21 CFR Karolo ea 211, le 21 CFR Karolo ea 11
Khamphani ha e re ha e qheleloe ka thoko ho karolo ea 21 CFR 820, 201, 211, 1.1
Pharmaceutical Contract Manufacturer FDA ngoliso # 3015266446
T&T has released several clinical batches in the US and internationally

boleng tiisetsa

Mafapha a Mahlale a T&T a Tiisetso ea Boleng le Taolo ea Boleng Netefatsa Boleng ba Lihlahisoa tsa Hao tsa Lithethefatsi, Litokiso tsa Batch, le Lipehelo hore li Ikamahanye le Melao le Melao e Phahameng ka ho Fetisisa.


latelwa

Lefapha le leng le le leng ke karolo ea ts'ebetso e ikhethileng ea mokhatlo, 'me mokhoa oa ho sheba boleng ke ona oa mantlha ho tsohle tseo re li etsang mona. T&T's Quality Operations e laoloa ke sebaka sa marang-rang Bukana ea Boleng. Sistimi ea Tsamaiso ea Boleng ea T&T Scientific Corporation e nka tataiso ho tsoa ho 21 CFR Karolo ea 820 ea Litsamaiso tsa Boleng mme e latela litlhoko tsohle tsa taolo ea FDA GMP ho kenyeletsoa 21 CFR Karolo ea 210, 21 CFR Karolo ea 211, le 21 CFR Karolo ea 11. Khamphani ha e re ha e qheleloe ka thoko ho 21 CFR. Karolo ea 820, 201, 211, 11 ho 7140 Regal Lane, Knoxville, TN 37918.


Sistimi ea Taolo ea Boleng ba Elektronike (eQMS): Qualio

Ha tlhahiso e phethiloe, sehlopha sa morero sea khethoa 'me boikarabello bo abeloa ho software ea tsamaiso ea projeke ea T&T (Monday.com) le sistimi ea taolo ea boleng ba elektroniki ea T&T (eQMS), Qualio. Tekanyetso ea likotsi le mathata a ka bang teng a amanang le phetisetso ea sehlahisoa e ea hlokahala ho tseba, ho lekola, le ho beha liketso bakeng sa mesebetsi ea ho fokotsa kotsi. Ts'ebetso ena ea tlhahlobo ea kotsi e laoloa ke mokhoa 'me e ngotsoe ho sebelisoa template ea FMEA bakeng sa tlhahlobo ena. Tekanyetso ena e lokela ho sebetsana le litlamorao life kapa life tse ka bang teng ho photefolio ea hajoale, ho latela melao, boleng, polokeho, joalo-joalo. Tlhahlobo ea pele ea likotsi tse ka bang teng tsa tšilafalo e amanang le ho hlahisoa ha lisebelisoa tse ncha le li-API li hlahlojoa bakeng sa ho tšoaroa ka ho khetheha le ho nahanela lisampole. Likotsi tse ka bang teng tsa tšilafalo e amanang le ho hlahisoa ha lisebelisoa tse ncha le li-API lia hlahlojoa. Tlhahlobo e lebisa tlhokomelo ho, mefuta e latelang ea lihlahisoa / lisebelisoa: cytotoxicity, lithibela-mafu, lihlahisoa tsa lisele, joalo-joalo Tlhahlobo ena ea kotsi e tla kenyelletsoa taolong ea phetoho e amanang le morero.

Leano la Boleng

1) Eketsa kelello ea boleng e khothalletsang takatso ea ho tsoela pele ho ntlafatsa. 2) Netefatsa hore ho latelwa ditlhoko tsohle tse sebetsang tsa taolo. 3) Netefatsa lihlahisoa le litšebeletso tse bolokehileng le tse sebetsang tse khotsofatsang litlhoko tsa bareki.


Control Quality

T&T Scientific e nang le bo-ramahlale ba tsebahalang lefatšeng ka bophara le mekhoa e thata ea taolo ea boleng, e etelletsoeng pele ke Dr. Drishti Sehgal, e netefatsa boleng ba lihlahisoa tse tlohang koporasi bo maemong a holimo ka ho fetesisa le ho latela litekanyetso le melaoana.


Nalane ea Tlhahlobo

T&T e ngolisitsoe le FDA, ngoliso ea FDA # 3015266446. Litsamaiso tsa boleng tsa T&T, SOPs, maano, le litšebeletso tsa motheo li tsamaisana le litlhoko tsa taolo tsa FDA, EMA, le JP bakeng sa ho hlahisa le ho etsa sehlahisoa sa lithethefatsi ho tšehetsa liteko tsa Pre-Clinical le Clinical. Bohle bao e ka bang bareki ba memeloa ho tla bona setsi sa rona le ho etsa tlhahlobo e lumellang konteraka. Ho khothaletsoa haholo ho etsa joalo. E lumella lihlopha ka bobeli ho qala ho theha likamano le ho utloisisa ts'ebetso ea rona betere. Leha ho le joalo, ka lebaka la seoa sena le likhaello tse ling tsa nako, rea hlokomela hore sena ha se khonehe kamehla. Selemong se fetileng, re ile ra amohela lihlahlobo tse 'maloa tse fumanehang ka ho nka maeto a sebele, lipuisano tsa Zoom, le litlhahlobo tsa litokomane. Tlhahlobo ea ho qetela e neng e le sebakeng e bile ea letsatsi le halofo e entsoeng ka la 01-Mar-21 ke moreki oa mose ho maoatle ea keneng konteraka ea tlhahiso le tlhahiso ea Pre-Clinical/Mokhahlelo oa 1 le rona kamora moo. Tlhahlobo e ile ea lekola sistimi eohle ea boleng, hammoho le lits'ebetso tsa aseptic fill/finish. Sehlopha sa pele sa Clinical se reretsoe ho tlatsoa ka Loetse 2021.

Ka ho ba teng ha Boleng bo matla mekatong ea tlhahiso, re khonne ho fana ka ka katleho lisebelisoa tse hlokahalang bakeng sa lifilimi tsa IND limmarakeng tsa US le tsa machabeng.


T&T Scientific e beha lihlahisoa tsa eona le boleng ba lits'ebeletso bohareng ba ts'ebetso ea eona ho netefatsa
polokeho ea basebelisi le bakuli ba sebelisang lihlahisoa le lits'ebeletso tsa T&T Scientific,
le ho nolofatsa ts'ebetso ea tumello ea FDA ea bareki ba eona

T&T Scientific e beha lihlahisoa tsa eona le boleng ba lits'ebeletso bohareng ba ts'ebetso ea eona ho netefatsa
polokeho ea basebelisi le bakuli ba sebelisang lihlahisoa le lits'ebeletso tsa T&T Scientific,
le ho nolofatsa ts'ebetso ea tumello ea FDA ea bareki ba eona