Kana tichitaura nezveDrug Master File, vagadziri vakasiyana vane maitiro akasiyana. DMF haisungirwe kuti vagadziri vanyore.Zvisinei, nhamba huru yevagadziri vezvinodhaka vachiri kunyorera uye kunyoresa DMF kune zvigadzirwa zvavo.Sei?
Kuti tidzike kubhizinesi, ngatitarisei zvirimo muDrug Master File kutanga, tozotaura nezve zvazvingaite!
Seti yakazara yemagwaro anoratidza kugadzirwa kwezvinodhaka uye manejimendi emhando inodaidzwa kuti Drug Master File (DMF), iyo inosanganisira kuunzwa kwenzvimbo yekugadzira (chirimwa), chakanangana nemhando yemhando uye nzira dzekuongorora, maitiro ekugadzira uye tsananguro yemidziyo, kutonga kwemhando uye mhando. management.
Ndeapi makambani anogona kunyorera DMF?
Kune MASHANU marudzi eDMF akapihwa neFDA:
Nyora I:Siti Yekugadzira, Zvishandiso, Maitiro Ekushanda, uye Vashandi
Rudzi II: Mushonga Wemushonga, Mushonga Wepakati, uye Zvinhu Zvinoshandiswa Mukugadzirira Kwazvo, kana Chigadzirwa Chezvinodhaka
Rudzi III: Packaging Material
Rudzi IV: Inobatsira, Ruvara, Ruvara, Essence, kana Chishandiso Chinoshandiswa Mukugadzirira Kwazvo
Rudzi V:FDA Inogamuchirwa Ruzivo Ruzivo
Zvinoenderana nemhando shanu dziri pamusoro, marudzi akasiyana emakambani anogona kuvanyorera zvinoenderana nezvavanoda kune ruzivo rwemukati rwunodiwa nemhando dzakasiyana dzeDMF.
Somuenzaniso, kana iwe uriAPI mugadziri, iyo DMF yaunoda kunyorera kubva kuFDA ndeyeRudzi II. Zvishandiso zvaunopa zvinofanirwa kusanganisira: kutumira chikumbiro, ruzivo rwakakodzera rwekutonga, bhizinesi rekuzvipira chirevo, tsananguro yemuviri nemakemikari zvimiro zvechigadzirwa chakaiswa, tsananguro yakadzama yemaitiro ekugadzira chigadzirwa. , kutonga kwemhando yechigadzirwa uye kugadzirwa kwemaitiro ekugadzirisa, bvunzo kugadzikana kwechigadzirwa, kurongedza uye kunyora mazita, akajairwa maitiro ekushandisa Kuchengeta uye manejimendi ezvigadzirwa uye zvigadzirwa zvakapedzwa, manejimendi ezvinyorwa, kuongororwa, batch nhamba manejimendi system, kudzoka uye kuraswa, nezvimwe.
Muzviitiko zvakawanda, iyo DMF yave chimwe chezvinhu zvakakosha kune imwe mhando yemushonga uye API kana ichikwanisa kutumirwa kune imwe nyika. Kana iwe uchida kupinda mumusika wekutengesa wedzimwe nyika, kuwanikwa kweDMF iyi kwakakosha. .
Sezvakangoita muEuropean Community, DMF chikamu cherezinesi rekutengesa. Pamishonga, seti yezvinhu ichaendeswa kuEuropean Community kana National Drug Administration yenyika inotengesa, uye rezinesi rekutengesa richabatwa. Kana mutengesi yezvinoshandiswa zvinoshandiswa (kureva API) inoshandiswa mukushandurwa kwezvinodhaka, maitiro ari pamusoro achashanda.DMF chikamu chakakosha chekushandisa.Kana DMF isingapiwi sezvinodiwa, zvigadzirwa zvinogadzirwa hazvigone kutengeswa kunyika.
DMF inoita basa rakakosha kune vagadziri.Parizvino, Hande iri kunyoreraMelatoninDMF.Panyaya yekunyoreswa kwegwaro,Hande ine makore mazhinji eruzivo rwekunyorera uye timu yehunyanzvi.The Rapid Response Center tine inokupa sarudzo dzakanakisa dzekuzadzisa zvaunoda munguva pfupi.Kana uchida kunyorera magwaro eDMF panguva kurairaMelatonin, ndapota inzwa wakasununguka kutibata nesu!
Nguva yekutumira: Sep-23-2022