Sichuan Deebio Pharmaceutical Co, Ltd. ubugenzuzi bwiminsi ibiri.Impuguke mu itsinda ry’ubugenzuzi zakoze igenzura ryimbitse rya sisitemu yo gucunga ubuziranenge bwa Deebio, sisitemu yo gucunga umusaruro, imikorere ikorerwa aho, imicungire ya laboratoire, hamwe n’ibikoresho bifasha ibikoresho, ndetse no kubungabunga sisitemu rusange.Binyuze mu igenzura, impuguke z’itsinda ry’ubugenzuzi zemeje kandi zemeza cyane uburyo bwa GMP bwo gucunga ubuziranenge bwa Deebio.Ku mbaraga zihuriweho n’abakozi bose b’ikigo, Deebio yatsinze neza icyemezo cya GMP cyemewe cy’Ubuyapani PMDA!

Ibyerekeye Ubuyapani PMDA

PMDA (Ikigo gishinzwe imiti n’ibikoresho by’ubuvuzi), kizwi kandi ku izina rya “Independent Administrative Legal Person Pharmaceutical and Medical Device Comprehensive Institution”, ni ikigo cy’Ubuyapani gishinzwe gusuzuma tekiniki y’ibiyobyabwenge n’ibikoresho by’ubuvuzi.Irasa na FDA yo muri Amerika na NMPA mu Bushinwa, bityo ikaba izwi kandi ku izina rya "Ubuyapani bushinzwe ibiyobyabwenge".

Inshingano nyamukuru nugukora ubuziranenge, umutekano, nibikorwa byibikoresho bya farumasi nibikoresho byubuvuzi.PMDA ishinzwe gusuzuma dosiye yatanzwe n’ibiyobyabwenge (MF) no gukora igenzura rya GMP ku bakora ibiyobyabwenge byo mu gihugu ndetse n’amahanga mu Buyapani, byombi bifitanye isano.

Ibiyobyabwenge bigomba kubanza gutsinda isuzuma rya tekiniki rya MF no gutsinda GMP kugenzura ahakorerwa mbere yo kwemererwa na PMDA.Abashinzwe inganda muri rusange bemeza ko amabwiriza ya PMDA aribwo buryo bukomeye kandi bwitondewe ku isi, kandi uburangare ubwo aribwo bwose buzatuma ihagarikwa ry’isuzuma rya MF cyangwa ubugenzuzi bwa GMP butananirwa, bikagira ingaruka ku gihe cyo gucuruza ibiyobyabwenge.

Ubuyapani buza ku mwanya wa 10 ba mbere mu bijyanye n'ubucucike bw'abaturage ku isi, ni igihugu cya gatatu mu bihugu bicuruza ibiyobyabwenge kandi kikaba kimwe mu bihugu bitatu bigize ICH (abandi banyamuryango bombi ni Amerika n'Ubumwe bw'Uburayi).Numunyamuryango wumuryango PIC / S.