Ku ya 27 Mata, 2024 - HumanwellCaps yateguye amahugurwa y’ubumenyi bw’ibanze bwa cGMP ku bakozi bayo hagamijwe guteza imbere iterambere ryiza rya - ryiza rya HumanwellCaps, gushyira mu bikorwa ingamba za mbere z’ibicuruzwa, kwihutisha imiterere mpuzamahanga, gutanga ibicuruzwa byiza na - by’ibicuruzwa byiza na serivisi by’abakiriya bo mu gihugu no mu mahanga, kugira ngo habeho ingaruka nziza n’umutekano w’ibicuruzwa bya capsule. Amasomo yafashwe ninzobere mu gucunga neza ubunararibonye muri urwo rwego.
Mu rwego rwo guteza imbere iterambere ryiza rya - rya HumanwellCaps, gushyira mu bikorwa ingamba za mbere z’ibicuruzwa, kwihutisha imiterere mpuzamahanga, gutanga ibicuruzwa byiza na serivisi - ku bakiriya b’imbere mu gihugu ndetse n’amahanga, kwemeza ubuziranenge n’umutekano by’ibicuruzwa by’ibiyobyabwenge, kugera ku ntego yo kuzamura imikorere myiza n’ubuziranenge bw’ibicuruzwa, kugabanya ingaruka n’amakosa. Ku ya 27 Mata 2024, Hubei Renfu Pharmaceutical Excipients Co., Ltd yakoresheje amahugurwa y’ubuziranenge "cGMP Training Basic Knowledge" ku bakozi bose, yigishijwe n’inzobere mu micungire y’ubuziranenge mu nganda.
Umuyobozi wa HumanwellCaps, Huang Jianhua, yashimangiye ijambo rye mu muhango wo gutangiza ko ubuziranenge ari ubuzima bw’ikigo. Gutezimbere imirimo yo gutanga FDA DMF ninzira ikenewe kugirango yujuje ibyifuzo byabakiriya bo mu gihugu ndetse n’abanyamahanga kugirango babone ubuziranenge, kandi ni nayo ntangiriro yo kuzamura buhoro buhoro ingufu zoroheje z’inganda. Kubaka sisitemu nziza ijyanye nibisabwa mpuzamahanga binyura mubuzima bwose bwibicuruzwa, kandi buri mukozi ni umuvugizi wikigo. Birakenewe guhora tunoza ubuhanga bwarwo hamwe nubuziranenge bwuzuye, kwizera byimazeyo igitekerezo cyamahugurwa ahindura imyumvire Umutimanama, umutimanama uhindura imyitwarire, hamwe n imyitwarire ihindura imyitwarire, kugirango ukurikize byimazeyo ibisabwa na cGMP. Hamwe numukiriya Ubwa mbere, kugirango ube umuyobozi wisi yose mubijyanye na farumasi yimiti igabanya agaciro kubakiriya.
Amahugurwa akubiyemo ahanini GMP yo mu Bushinwa (2010), US FDA cGMP 21CFR IGICE CYA 210 NA 211, EUGMP2008, ICH Q7 Isubiramo, gusobanura mu buryo burambuye no gushyira mu bikorwa amabwiriza amwe, hamwe n’ubushakashatsi bwakozwe hamwe n’imiterere y’imishinga. Muri icyo gihe, yibanda kandi ku bikoresho bisanzwe kandi bya kera byifashishwa mu gusesengura ubuziranenge, kugira ngo abitabiriye amahugurwa bashobore gusobanukirwa byimbitse na sisitemu y’imyumvire, ariko no ku mirimo ya buri munsi.
Isomo ryo kwigisha rirangiye, umwigisha wamahugurwa yatanze ibisubizo birambuye kubibazo byabahugurwa. Muri icyo gihe kandi, isosiyete yateguye kandi ikora isomo ryo Gutekereza no Gusangira Ibyerekeye Imicungire y’ubuziranenge, abayobozi bakuru ba HumanwellCaps n’abayobozi b’amashami, abahagarariye abakozi ku mahugurwa y’imyumvire, abakozi bahuguwe gusangira no kuganira, kugira ngo ibitekerezo n’imitekerereze y’imicungire y’ubuziranenge birusheho kwinjira mu mitekerereze n’imyitwarire ya buri mukozi.
