Nhamba Yemashoko
MuUSA, misimboti yeGMP yakafukidzwa muchikamu 210 uye chikamu 211 chekodhi yemitemo yemubatanidzwa.Nekuti iyi mirau yakaoma kugadzirisa kana kuwedzera, FDA yakaburitsa magwaro akasiyana 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 ekuitisa nzira yekusimbisa, gadziriso yekusimbisa uye zvimwe zvirimo nezve GMP zvakasanganisirwa mumagwaro aya, ari iwo mazinga anotevedzwa muGMP pa-saiti ongororo.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 kana mashandiro emugadziri anosangana neiyi "ikozvino" chiyero, vagadziri vezvinodhaka vanofanirwa kutevedzera yazvino cGMP nemamwe madhiraivha 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, mashandiro ekugadzirisa, nzira yekusimbisa, sterilization kusimbiswa uye dzimwe nzira dzekushanda dzakaitwa pasina akadzama zviyero, izvo zvinokonzeresa kutungamira kumashure.
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Nguva yekutumira: Nov-03-2017