Sichuan Deebio Pharmaceutical Co., Ltd. (yomwe tsopano imadziwika kuti Deebio) inayendera ndi kuyang'anira kutsata kwa GMP kuchokera ku PMDA ku Japan kuyambira pa Ogasiti 25 mpaka pa Ogasiti 26, 2022. Gulu lofufuza za GMP linapangidwa ndi akatswiri awiri owerengera ndalama 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 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 anthu.Kupyolera mu kuyendera, akatswiri a gulu loyang'anira adatsimikizira ndi kuzindikira njira yoyendetsera bwino ya Deebio's GMP.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.Zimagwira 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 Yogulitsa Mankhwala (MF) ndikuwunika kwa GMP kwa opanga mankhwala apanyumba ndi akunja ku Japan, onse omwe amalumikizidwa.

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

Japan, yomwe ili m'gulu la 10 otsogola potengera kuchuluka kwa anthu padziko 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.