Nkuruganda rwa GMP rufite ibyiza byinshi mugukuramo ibihingwa, gutandukana no guhuza, kugenzura ubuziranenge bwibicuruzwa ni ngombwa.Hande bioifite amashami abiri mu kugenzura ubuziranenge bwibicuruzwa, aribyo Ishami rishinzwe ubuziranenge (QA) n’ishami rishinzwe kugenzura ubuziranenge (QC).
Ibikurikira, reka twigire hamwe amashami yacu yombi!
Ubwishingizi bufite ireme ni iki?
Ubwishingizi bufite ireme bivuga ibikorwa byose byateganijwe kandi byuzuye bishyirwa mubikorwa muri sisitemu yo gucunga ubuziranenge kandi bikagenzurwa nkuko bisabwa kugirango ibicuruzwa cyangwa serivisi bishobore kuba byujuje ubuziranenge.
Sisitemu yubwishingizi bufite ireme ni ugutunganya, gutunganya no gushyira mubikorwa ibikorwa byubwishingizi bufite ireme binyuze muri sisitemu, amategeko, uburyo, inzira ninzego.
Dufatanije n’ibikorwa by’isosiyete, twashyizeho uburyo bwo gucunga neza harimo imikorere yimikorere no kugenzura ubuziranenge bwibicuruzwa, ingamba zo gukosora no gukumira, guhindura imiyoborere no gusuzuma imiyoborere.Ubu buryo bwo kwemeza ubuziranenge bushingiye kuri sisitemu esheshatu zikomeye za FDA, bujuje ibisabwa n'Ubushinwa, Amerika n'Uburayi, kandi bugenzurwa igihe icyo ari cyo cyose.
Kugenzura Ubuziranenge ni iki?
Kugenzura ubuziranenge bivuga ingamba za tekiniki ningamba zo gucunga zafashwe kugirango ibicuruzwa cyangwa serivisi byuzuze ibisabwa.Intego yo kugenzura ubuziranenge ni ukureba niba ubuziranenge bwibicuruzwa cyangwa serivisi bishobora kuzuza ibisabwa (harimo ingingo zisobanutse, zisanzwe cyangwa ziteganijwe).
Muri make, umurimo wingenzi w'ishami ryacu QC ni ukugenzura ubuziranenge bwinganda n’ibicuruzwa byacu, no gusuzuma niba ibicuruzwa dukora byujuje ubuziranenge mu bijyanye na mikorobe, ibirimo n’ibindi bintu kandi bishobora guhaza ibyo abakiriya bakeneye.
Igihe cyo kohereza: Kanama-26-2022