Chii Chinonyatsodhindwa Purogiramu?
DMF inofanirwa kugovera zvinhu zvakawanda kuUnited States, asi FDA haiti kuti vese vapeki vape DMF. Zvisinei, ruzivo rwakanyorwa muDMF runogona kushandiswa kutsigira Investigational New Drug Application (IND), New Drug Application (NDA), Bhivi reNew Drug Application (ANDA), rimwe DMF, Export Application, kana zvinyorwa zvine chokuita.
Dhiyabhorosi inoti DMF haigoni kuiswa panzvimbo ye IND, NDA, ANDA kana Export Application. "Hazvibvumirwi kana kuti hazvibvumirwi," maererano neCDA. "Chirongwa cheDMF chinongororwa chete maererano nekuongororwa kweInd, NDA, ANDA, kana Kushandiswa Kwokutengeserako."
API vadziki vane nhamba yakawanda yeDMFs vanowanzoonekwa sevimbiso yakawanda maererano nehutano, humiriri hwehutungamiri, uye kukwanisa kusangana neAkan Good Good Manufacturing Process (cGMP) zvinoda.
DMF isati yasvika inogona kuongororwa, muiti anofanira kuisa mafomu ekutsvaga mafomu anoratidza DMF. Hasi yose DMFs inodzokororwa neRDA, uye iyo DMF yezvibereko haigone kuti mudziki ari kubudisa icho chigadzirwa kana kukwanisa kuchipa kuUnited States.
Munguva yakapfuura, kutumira DMF ndiyo nzira yezvikwata zvishoma zvakasimbiswa kutora chidimbu chekuvimbika apo ichiedza kutengesa mumusika weAmerica uye mamwe mabhizimisi anotongwa.
Zvisinei, sezvo DMFs inongoongororwa apo anAA kana NDA inorondedzera kwavari, DMF iyo isina kutaridzwa ndeyekusavhiringidza kunyange kana DMF muiti anofunga kuva neDMF inoita kuti iite seyakarurama. Kuisa DMFs pasina vatengi muUnited States zvishoma nezvishoma, saka DMFs dzakawanda zvekare dzinoratidza zvirongwa zvechinangwa chokugadzira kudarika DMF dzakwegura.
Mishanu YeDMFs
Tanga I: Manufacturing site, zvivako, maitiro ekushanda nevashandi kwete zvakananga kune zvinodhaka. Ita I DMFs haisati yagamuchirwa neCDA, asi vakwegura vanoramba vari pafaira.
Rudzi rwepiri: Zvinodhaka zvinodhaka, zvinhu zvinoshandiswa mumidziyo, uye zvinhu zvinoshandiswa mukugadzirira kwavo, kana chigadzirwa chemishonga. A Type II DMF, iyo inowanzozivikanwa, inogona kuvhara fomu fomu yemishonga inogadzirwa pasi pesangano yeimwe kambani inogona kuisa ANDA.
Rudzi rwechitatu: Packaging materials, kubva mabhodhoro uye makapu kusvika kuPVC resin yakashandiswa mukugadzira kwavo inofanira kuiswa muDMF kana imwe dhiyabhorosi yeDAA yakadai seNADA.
Rudzi IV: Excipient, colorant, flavor, essence kana kuti DMF. Vanofadzwa nemakemikari asingabatsiri zvinhu zvakadai sezvokudya kana cellulose zvinoshandiswa kusunga poda yezvinodhaka pamwechete kuitira kuti inogona kudzvinyirirwa muhwendefa. Mimwe mimwe mienzaniso inosanganisira kuvhengana mune zvinodhaka zvevana, doro muzvinwiwa, nezvimwewo.
Tora V: FDA yakagamuchira ruzivo rwekutsvaga isina kuiswa mune dzimwe mhando.
I-FDA inoda kuti DMFs ive ikozvino panguva iyo ichiongororwa. Mitemo yeDDA inotaura nezveDMF inoti: "Chero kuwedzera, kuchinja, kana kubviswa kwemashoko mune imwe mishonga yemapurisa faira (kunze kwerwendo rwuri pasi pechikamu (d) chechikamu chino) rinofanira kuiswa mumakopi maviri uye kurondedzera nezita, nhamba yefodhi, ivhu, uye peji nhamba iyo mashoko akabatwa muzvinodhaka master file. "
I-FDA inoita kuti DMFs ikozvino. Kana kambani isina kuendesa mushumo wegore mumakore matatu, sangano rinotumira "Tsamba Dzokunyora Ivo" kune DMF vadzidzisi. Muchengeti ane mazuva makumi mapfumbamwe kuti apindure uye anyore mushumo wegore negore. Kana vakakundikana kupindura, DMF yavo inogona kuvharwa.
Mutungamiri weDAA weDrug Master Files unogona kuwanikwa pawebsite.