Nhamba Yemashoko
MuUSA, misimboti yeGMP yakafukidzwa muchikamu 210 uye chikamu 211 chekodhi yemitemo yemubatanidzwa.Nekuti iyi mirau yakaoma kugadzirisa kana kuwedzera, FDA yakaburitsa akasiyana magwaro eGMP mirau uye nhungamiro yekushanda kwemishonga, senge.Nhungamiro yeIndasitiri.Aya anogara achigadziridzwa uye akawedzerwa mafaera anonzi CGMP nhungamiro.Mimwe yeiyi nhungamiro ine chekuita nekutsvaga kutsva kwezvinodhaka uye kunyoresa, seICH (Q1-Q10).Maitiro ekuita nzira yekusimbisa, gadziriso yekusimbisa uye zvimwe zvirimo nezve GMP zvakaverengerwa mumagwaro aya, ari iwo mazinga anotevedzwa muGMP pa-saiti yekuongorora.Uye zvakare, mamwe nhungamiro inoburitswa yeGMP inspectors semareferensi, sengeNhungamiro yeKuongororwa kweDosage Fomu Vagadziri vezvinodhaka, Nhungamiro Yekuongorora Kwemhando Yemasisitimu, Kusimbiswa kweMaitirwo Ekuchenesaetc. Hazvimanikidzi kushandisa mazano aya.Nekuti chete FDA inspectors ndivo vane mvumo yekusarudza kuti mashandiro emugadziri anosangana neiyi "ikozvino" chiyero, vagadziri vezvinodhaka vanofanirwa kutevedzera yazvino cGMP nemamwe nhungamiro uye vazvitarise ivo pachavo kuti vaone kana zviyero zvaitwa.Zvikasadaro, vaizoonekwa se "vasina kutenderwa" uye vanorangwa nazvo.
Chinese GMP (1998 edition) yakapusa uye haina kujeka, haina madhairekitori akatsanangurwa uye zvinodiwa zvinoenderana nemisimboti yeGMP.Muapendikisi yeGMP ya1998, marudzi matanhatu emishonga akaunzwa aine nhungamiro pfupi.Parizvino, kuchine kushama muGMP ichipa mareferensi ekutungamira ekushanda.Equipment qualification uye kusimbiswa, process yekusimbisa, nzira yekusimbisa, sterilization kusimbiswa uye mamwe chaiwo maitiro ekushanda akaitwa pasina akadzama mwero, izvo zvinokonzeresa kumashure manejimendi.
Tumira meseji yako kwatiri:
Nguva yekutumira: Nov-03-2017