Izvo Zviduku Zviduku zveDefA
Gore iroro, akanyora John P. Swann, munyori wezvakaitika kare we FDA, Winthrop Chemical Company yeNew York yakatanga kutengesa mahwendefa akasvibiswa akaendesa kumazana ekukuvara nekufa.
Tsvakurudzo yeDWA yeWinthrop yakaratidza kukanganisa kwakanyanya muzvivako uye matambudziko echokuita mukuyeuka zvinhu zvakasvibiswa. World Health Organization (WHO) yakanyora maitiro ayo akanaka ekutengesa kwekugadzira nekugadzirisa kunaka kwezvinodhaka muna 1967 uye yakagamuchirwa neChirungu cheMakumi maviri chekutanga World Health Assembly.
Maitiro Akanaka Akanaka Okugadzira MuUnited States
MuUnited States, Maitiro Akanaka Akanaka Okugadzira, kana cGMP, ndiyo mitemo yeDFA yakarongeka iri mumitemo nemasangano ehurumende uye inofunga nezvekugadzirisa, kuongorora nekudzivirira kwezvinangwa zvekugadzira uye zvivako. Kuwedzerwa kwe "ikozvino" zvinoyeuchidza vadziki kuti vanofanira kushandura magetsi nemashandisirwo emamiriro ezvinhu kuitira kuti vave maererano nemitemo.
IA FDA inoda kuti vashandi vekurapa vateerere mitemo iyi inopa kuvimbiswa kwechiratidzo chechigadzirwa chemishonga, simba, unhu, uye kuchena.
Vamwe vanogadzira mishonga vanogadzira hutano hwehutano uye hutsika hunopfuura huwandu hutsika hweCGMP.
Kuteerera kune cGMP kunoda vashandi kuti vagadzirise hutano hwehutano hwakanaka, kuwana zvinhu zvakanakisa zvezvinhu zvakagadzirwa, kutanga zvirongwa zvekushanda, kuona uye kutsvakurudza zvinetso zvinokonzerwa nehutano hwezvigadzirwa, uye kuchengetedza mabhuku ekuongorora anovimbika.
I-FDA ine simba rekutonga rekuongorora zvivako zvekushandisa zvinodhaka zvinoshandiswa pakutevedzera neCGMPs.
Kuongorora kweDAA yemuchina wekugadzira mishonga inosanganisira kuongorora kana nzvimbo yacho iri kutevera mitemo yeCGMP. Kuongororwa kunogona kunge kusinganzwisisiki kana kunogona kukonzerwa nemishumo yakaipa yezviitiko kubva kuvanhu vose kana kumabhizimusi.
Kana Mutengi Anowanikwa Kwete-Inoenderana neCGMP Mitemo
Kana kuchitevera kuongorora kweDFA, muiti anowanikwa asingateereri nemitemo yeCGMP, FDA ichabudisa Fomu 483 iyo iyo kambani inofanira kupindura netsanangudzo, kana inoda, matanho ekugadzirisa matanho. "Izvi zvakarongeka zvekambani kune imwe kambani yemishonga, kana ikashandiswa zvakajeka, inobatsira kudzivirira mamiriro ekusvibiswa, kusanganisa-ups, kukanganisa, kukundikana, nekukanganisa," maererano neCDA.
Iro cGMP mitemo, zvinyorwa zvekutungamira, nezvimwewo zvigadziro zvekubatsira makambani emishonga zvinoteerera mutemo zvinogona kuwanikwa pawebsite yeDWD, uye kuburikidza nevanomiririra vhizimisi veDAA, Mahofisi eSuwa, uye kubva kuChirongwa cheDrug Assessment nekutsvaga, Office of Compliance , Kugoverana kwekugadzira uye kugadzirwa kwekodzero. Kuchinja kumitemo uye kuvandudzwa kwezvinyorwa zvekutungamira zvakare zvakabudiswa mu Federal Register.
Apo Kambani Inodzvinyirira cGMP Chisimba
Kunyange zvazvo FDA isina simba rekuda kambani kurangarira mishonga kana kuchengetedzwa kwechirwere ichi chiri mubvunzo, makambani anowanzoyeuka nokuzvidira kana pane chikumbiro cha FDA. Kana kambani isingabvumirwi kuyeuka chirwere, FDA inogona kupa nyevero yevanhu pamusoro pemishonga uye kubata mishonga uye kuvabvisa kubva pamusika. Maererano neDFA, "Kunyange kana mishonga iyi isiri yakakwana, FDA inogona kutora chikwata kana kukonzera mhosva mumatare kuti ataure kukanganisa kweCGMP."
Maitiro Akanaka Akanaka Okugadzira Maitiro Rutsigiro
- Utano Canada: Maitiro Akanaka Okugadzira
- European Commission: GMP Zvinyorwa
- World Health Organisation: WHO Inobatsira Maitiro Okugadzira
- Mishonga uye Healthcare Products Regulatory Agency (MHRA-UK): Maitiro Akanaka Okugadzira
Mienzaniso Yezviito Nekurovedzwa Yakabatanidzwa muCGMP Zvido
- Maintenance, calibration uye kuvimbiswa kwemichina
- Mamiriro ezvivako
- Zvikwereti uye kudzidziswa kwevashandi
- Kutendeseka uye kuberekwa kwezviitiko
- Nzira yekuedzwa yekugadzirisa
- Kutungamira kwekunyunyuta