Sichuan Deebio Pharmaceutical Co., Ltd. (inozonzi Deebio) yakaita ongororo yepamutemo yeGMP kubva kuPMDA muJapan kubva Nyamavhuvhu 25 kusvika Nyamavhuvhu 26, 2022. Chikwata chekuongorora cheGMP chakaumbwa nevaongorori vaviri vachitungamirirwa nenyanzvi dzine ruzivo uye mazuva maviri kure kure audit.Nyanzvi dzechikwata chekuongorora dzakaita ongororo yakakwana yeDeebio's quality management system, kugadzirwa kwehurongwa hwekugadzira, kushanda panzvimbo, manejimendi emurabhoritari, pamwe nenzvimbo dzinotsigira nemidziyo, uye kuchengetedza masisitimu everuzhinji.Kuburikidza nekuongorora, nhengo dzenyanzvi dzechikwata chekuongorora dzakabvumirana uye dzakanyatsozivikanwa Deebio's GMP mhando yekutonga system.Nekuedza kwakabatana kwevashandi vese vekambani, Deebio akabudirira kupasa yepamutemo GMP certification yeJapan PMDA!

Nezve Japan PMDA

PMDA (Pharmaceuticals and Medical Devices Agency), inozivikanwawo se “Independent Administrative Legal Person Pharmaceutical and Medical Device Comprehensive Institution”, isangano reJapan rinoona nezvekuongorora kwehunyanzvi kwezvinodhaka nemidziyo yekurapa.Inoshanda zvakafanana neFDA muUnited States neNMPA kuChina, saka inozivikanwawo se "Japan Drug Administration".

Basa guru nderekuona kunaka, kuchengetedzwa, uye kushanda kwezvigadzirwa zvemishonga nemidziyo yekurapa.PMDA ine basa rekuongorora zvese zvakatumirwa Drug Master File (MF) uye kuita ongororo yeGMP kune vagadziri vezvinodhaka vekumba nekunze muJapan, ese ari maviri akabatana.

Mushonga unofanirwa kutanga wapfuura ongororo yehunyanzvi yeMF uye kupfuudza kuongororwa kweGMP kwenzvimbo yekugadzira usati wawana mvumo yePMDA.Indasitiri vemukati vanowanzotenda kuti mutemo wePMDA wakanyanya kusimba uye wakanyanya kungwarira pasirese, uye chero kusangwarira mune zvakadzama kunotungamira kumisa kwekuongorora kweMF kana kutadza kwekuongorora kweGMP, zvichikanganisa nguva yekutengesa mishonga.

Japan, iyo iri pakati pegumi pamusoro pehuwandu hwevanhu pasirese, inyika yechitatu pamusika wezvinodhaka uye imwe yenhengo nhatu dzakakosha dzeICH (dzimwe nhengo mbiri iUnited States neEuropean Union).Iyo zvakare inhengo yePIC/S sangano.