Epoxy yo kwisiga irangi hasi ni ahantu hasanzwe mu nganda zimiti n’ibiribwa, kubera ko ishobora gukora ubutaka bwera kugira ngo bujuje ibisabwa na GMP mu nganda z’imiti n’ibiribwa.GMP n’icyemezo cya gatatu cy’imbere mu gihugu icyemezo cy’umutekano giteganijwe mu nganda z’imiti, kode ni C12, ijyanye n’amabwiriza ya Repubulika y’Ubushinwa ku ishyirwa mu bikorwa ry’amategeko ngenderwaho cumi n'umunani.
Icyemezo cya GMP gihuza ISO900 ~ 9004 gisanzwe, Icyemezo cyo kugura ibikoresho, kugikora, gukora, gupakira no kugurisha ibigo bikorerwamo ibya farumasi, kugirango umutekano n’ibikorwa by’imiti ikorwa n’amasosiyete akora imiti.Icyemezo cya farumasi yimiti yo muri Amerika ni FDA.
1, GMP ni iki?
GMP nigikorwa cyiza cyo gukora, bivuze gucunga neza ibicuruzwa, ni itegeko ryo kuyobora ibicuruzwa nubwiza bwibiribwa, imiti nibicuruzwa byubuvuzi.
2, kubera iki dukora ibi?
Umubare w'ibiyobyabwenge bigira ingaruka ku buryo butaziguye ingaruka zo kuvura, byinshi cyangwa bike bizatera ingaruka mbi ku buzima bw'umurwayi.Muburyo rero bwo gukora ibiyobyabwenge, uruhande rumwe kugirango rwirinde izindi bagiteri gutwarwa, kurundi ruhande kugirango igenzure umukungugu nibindi bintu byuzuye byuzuye, bizagira ingaruka kumiterere yibirimo yibiyobyabwenge.Uruganda rwa farumasi rero uruganda rukora imiti kugirango rwuzuze byimazeyo ibisabwa na GMP.
3, ni ubuhe buryo burambuye?
Uruganda rwa farumasi rwa GMP kubisabwa kugira isuku y’ibidukikije rugabanijwemo ibihumbi 300, ibihumbi 100, ibihumbi icumi, ijana n’ibindi, ahantu rusange hakorerwa nta bisuku bisabwa;agace kagenzura, Amahugurwa yimiti aisle asabwa muri rusange ibihumbi 100 -30;ahantu hasukuye harakenewe hagati yicyiciro cyogusukura ikirere.
Kuberako ibyinshi mubisiga irangi bidashobora guhaza GMP, hari igicuruzwa gishya cyo gusiga irangi, cyiswe kwishyiriraho epoxy hasi irangi, gishingiye kubintu 100% bikomeye bigize epoxy resin idasanzwe nkibikoresho fatizo, Hamwe nicyatsi kurengera ibidukikije, ububengerane bwinshi, uburebure bwa firime, imbaraga za firime hamwe n’imyenda idashobora kwangirika hamwe nibindi bintu byiza biranga, bishobora guhaza isuku ihanitse y’uruganda rwa elegitoroniki, uruganda rukora imiti n’ahandi hantu hashyizweho uburyo bwiza bwo gutwikira hasi.
Igihe cyo kohereza: Apr-12-2023