Kodi Fayilo Yoyang'anira Drug ndi chiyani?

Polankhula za Fayilo Yophunzitsa Mankhwala Osokoneza Bongo, opanga osiyanasiyana amakhala ndi machitidwe osiyanasiyana.DMF sizokakamizidwa kuti opanga alembetse.

Kuti titsike ku bizinesi, tiyeni tiwone zomwe zili mu Fayilo Yoyang'anira Mankhwala kaye, kenako tikambirane zomwe ingachite!

Zolemba zathunthu zowonetsa kupanga mankhwala ndi kasamalidwe kabwino zimatchedwa Drug Master Fayilo (DMF), zomwe zimaphatikizapo kukhazikitsidwa kwa malo opangira (chomera), mawonekedwe amtundu wake ndi njira zowunikira, njira zopangira ndi kufotokozera zida, kuwongolera kwaubwino ndi mtundu. kasamalidwe.

Ndi makampani ati omwe angalembetse ku DMF?

Pali mitundu 5 ya DMF yoperekedwa ndi FDA:

Mtundu Woyamba: Malo Opangira, Zida, Njira Zogwirira Ntchito, ndi Ogwira Ntchito

Mtundu Wachiwiri: Mankhwala Osokoneza Bongo, Mankhwala Osokoneza Bongo Apakati, ndi Zinthu Zogwiritsidwa Ntchito Pokonzekera, kapena Mankhwala Osokoneza Bongo

Mtundu III: Packaging Material

Mtundu IV: Zothandizira, Zamtundu, Zokometsera, Zofunika, kapena Zinthu Zogwiritsidwa Ntchito Pokonzekera

Mtundu V: Chidziwitso Chovomerezeka cha FDA

Malinga ndi mitundu isanu yomwe ili pamwambayi, makampani amitundu yosiyanasiyana amatha kuwafunsira malinga ndi zosowa zawo pazambiri zomwe zimafunidwa ndi mitundu yosiyanasiyana ya DMF.

Mwachitsanzo, ngati ndinuWopanga API, DMF yomwe muyenera kufunsira kuchokera ku FDA ndi ya Mtundu II. Zida zomwe mumapereka ziyenera kuphatikizapo: kutumizira, chidziwitso chokhudzana ndi kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe kake. ,kuwongolera kwaubwino wazinthu ndi kuwongolera njira zopangira,kuyesa kukhazikika kwazinthu,kuyika ndi kulemba,njira zokhazikika zogwirira ntchito Kusungirako ndi kasamalidwe ka zopangira ndi zinthu zomalizidwa,kasamalidwe ka zikalata,kutsimikizira,kasamalidwe ka manambala a batch,kubweza ndi kutaya, etc.

Nthawi zambiri, DMF yakhala imodzi mwazinthu zofunika kwambiri pamtundu wina wa mankhwala ndi API ngati zitha kutumizidwa kudziko lina. Mukafuna kulowa mumsika wogulitsa wamayiko ena, kupezeka kwa DMF iyi ndikofunikira. .

Monga momwe zilili ku European Community, DMF ndi gawo la chiphaso cha malonda. Pa mankhwala, gulu la zinthu lidzaperekedwa ku European Community kapena National Drug Administration ya dziko logulitsa, ndipo chilolezo cha malonda chidzayendetsedwa. za zomwe zimagwira ntchito (ie API) zomwe zimagwiritsidwa ntchito posintha mankhwala, njira zomwe zili pamwambazi zidzagwiritsidwa ntchito.DMF ndi gawo lofunika kwambiri la zipangizo zogwiritsira ntchito.

DMF imagwira ntchito yofunika kwambiri kwa opanga.Pakali pano, Hande ikufunsiraMelatoninDMF. Pankhani yolembetsa zikalata, Hande ali ndi zaka zambiri zogwiritsa ntchito komanso gulu la akatswiri. The Rapid Response Center tili ndi mwayi wosankha zomwe mungachite kuti mukwaniritse zosowa zanu munthawi yochepa kwambiri. kuyitanitsaMelatonin, chonde omasuka kulankhula nafe!