Sichuan Deebio Pharmaceutical Co., Ltd. (amene pano akutchedwa Deebio) anayendera GMP kuchokera ku PMDA ku Japan kuyambira pa Ogasiti 25 mpaka pa Ogasiti 26, 2022. Gulu lofufuza za GMP linapangidwa ndi owerengera ndalama awiri motsogozedwa ndi akatswiri odziwa zambiri ndipo adachita kafukufuku. masiku awiri akutali audit.Akatswiri a gulu loyang'anira adayang'anitsitsa machitidwe a Deebio, kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka ntchito, kayendetsedwe ka labotale, komanso zipangizo zothandizira ndi zipangizo, komanso kukonza machitidwe a anthu.Kupyolera mu kuyendera, akatswiri a gulu loyang'anira adatsimikizira ndikugwirizana kwambiri ndi Deebio's GMP management management system.Ndi kuyesetsa kwa onse ogwira ntchito pakampani, Deebio adapambana chiphaso cha GMP cha Japan PMDA!

Za ku Japan PMDA

PMDA (Pharmaceuticals and Medical Devices Agency), yomwe imadziwikanso kuti "Independent Administrative Legal Person Pharmaceutical and Medical Device Comprehensive Institution", ndi bungwe la ku Japan lomwe limayang'anira kuwunika kwaukadaulo kwamankhwala ndi zida zamankhwala.Imagwira ntchito mofanana ndi FDA ku United States ndi NMPA ku China, choncho imadziwikanso kuti "Japan Drug Administration".

Udindo waukulu ndikuwonetsetsa kuti zabwino, chitetezo, ndi mphamvu za mankhwala ndi zida zamankhwala.PMDA ili ndi udindo wowunikanso Fayilo ya Drug Master (MF) yotumizidwa ndikuwunika za GMP kwa opanga mankhwala apakhomo ndi akunja ku Japan, onse omwe ali olumikizidwa.

Mankhwalawa ayenera kupititsa patsogolo kuwunika kwaukadaulo kwa MF ndikudutsa kuwunika kwa GMP pamalo opangira asanalandire chilolezo cha PMDA.Ogwira ntchito m'mafakitale amakhulupirira kuti malamulo a PMDA ndi okhwima kwambiri komanso osamala kwambiri padziko lonse lapansi, ndipo kusasamalira mwatsatanetsatane kungayambitse kudodometsa kwa kuwunika kwa MF kapena kulephera kwa kuwunika kwa GMP, zomwe zimakhudza nthawi yogulitsa mankhwala.

Japan, yomwe ili pakati pa 10 otsogola potengera kuchuluka kwa anthu padziko lonse lapansi, ndi dziko lachitatu pamisika yayikulu yamankhwala ndipo ndi amodzi mwa mamembala atatu a ICH (mamembala ena awiriwa ndi United States ndi European Union).Ndi membala wa bungwe la PIC/S.