GMP (Good Manufacturing Practice) igwara rine chinangwa chekudzora nekutarisa mabasa ekugadzira mishonga pasi rese.Iyo zvakare mvumo inodiwa kune vagadziri vemishonga kuti vapinde mundima yekutengeserana nedzimwe nyika.
GMP inosanganisira: nzvimbo, vanhu, nzvimbo, hutsanana, kusimbiswa, gwaro, kugadzirwa, kunaka, kutengesa, kushandiswa zvakare uye kuongorora etc. Iine mitemo yakasimba yetekinoroji, kutarisira hurongwa uye kutonga kwekusimbisa kudzivirira: kuvhiringidzika pakati pezvigadzirwa, utachiona hwemuchinjikwa uye kusvibiswa kubva mimwe mishonga, kusiyanisa uye kutsauka kubva mukusanganiswa kwezvikamu zvakasiyana-siyana, tsaona dzekushayikwa nhanho dzekuongorora, kushanda kusina kunaka uye mamwe maitiro asina kukodzera.
Pfungwa yeGMP yakaunzwa muma80s eChina uye yakaziviswa zviri pamutemo seyakakwana uye inosungirwa mutemo muna Chikunguru 1.st, 1999. MuU.SA, cGMP (pfupi yeCurrent Good Manufacture Practices) yakabudiswa muCFR chikamu 210 uye chikamu 211 mu90s.
Pakazara, chinangwa, musimboti, chidzidzo uye chinodiwa cheChinese GMP chakada kufanana neicho cheAmerican cGMP asi chokwadi kune misiyano yakawanda seinotevera.
Nzira yekubvumirwa
Chitupa cheChinese GMP chingori chitupa chemvumo yekugadzira mishonga, kusasanganisa kunyoreswa kwechigadzirwa.Mushure mekunge mugadziri atenderwa chigadzirwa chitsva nenhamba yekunyoresa, inokwanisa kuenderera mberi nekushandiswa kweGMP certification.Zvakare, dhata remabheji matatu ekugadzira uye dhata yekudzikama yekuongorora mukati memwedzi mitanhatu inodiwa kuendesa kunyoreswa kwechigadzirwa kana GMP certification.
Chitupa cheAmerican cGMP chine zvikamu zviviri: Kuvandudza Chigadzirwa uye Chemical Manufacture Control.Izvi zvinoreva kuti kunyoreswa kwekugadzira uye mvumo yekugadzira iri kuitika panguva imwe chete.Kune marudzi maviri ekunyoreswa kwechigadzirwa muUSA: New Drug Application (NDA) uye yakapfupikiswa New Drug Application (ANDA).NDA inoda data remabheji matatu ekugadzira uye data yekudzikama yekuongorora mumwedzi mitanhatu.ANDA inoda data yebheti yekugadzira uye data yekudzikama yekuongorora mumwedzi mitatu.Dhata yekuenderera mberi kwekuongorora uye kusimbiswa ichachengetedzwa nemugadziri uye kuziviswa mushumo wegore kune FDA.
Tumira meseji yako kwatiri:
Nguva yekutumira: Oct-27-2017