Ua mālama ʻia ʻo Sichuan Deebio Pharmaceutical Co., Ltd. (i kapa ʻia ʻo Deebio) i ka nānā ʻana i ka GMP compliance inspection mai ka PMDA ma Iapana mai ʻAukake 25th a hiki i ʻAukake 26th, 2022. ʻO ka hui loiloi GMP i haku ʻia e ʻelua mau loiloi i alakaʻi ʻia e nā poʻe loea. ʻelua lā loiloi mamao.Ua hoʻokō ka poʻe loea i ka nānā ʻana i ka ʻōnaehana hoʻokele maikaʻi o Deebio, ka ʻōnaehana hoʻokele hana, ka hana ma ka pūnaewele, ka hoʻokele laboratory, a me nā mea kākoʻo e pili ana a me nā lako, a me ka mālama ʻana i nā ʻōnaehana lehulehu.Ma o ka nānā ʻana, ua ʻae like a ʻike ʻia ka ʻōnaehana hoʻokele maikaʻi o Deebio o ka hui nānā.Me ka hui pū ʻana o nā limahana a pau o ka hui, ua lanakila ʻo Deebio i ka palapala hōʻoia GMP o Iapana PMDA!

No Iapana PMDA

ʻO PMDA (Pharmaceuticals and Medical Devices Agency), i ʻike ʻia ʻo "Independent Administrative Legal Person Pharmaceutical and Medical Device Comprehensive Institution", he hui Kepani ke kuleana no ka loiloi loea o nā lāʻau lapaʻau a me nā mea lapaʻau.Hoʻohana like ia me ka FDA ma ʻAmelika Hui Pū ʻIa a me ka NMPA ma Kina, no laila ua kapa ʻia ʻo ia ʻo "Japan Drug Administration".

ʻO ke kuleana nui e hōʻoia i ka maikaʻi, palekana, a me ka pono o nā huahana lāʻau lapaʻau a me nā mea lapaʻau.Na PMDA ke kuleana no ka nānā ʻana i ka Drug Master File (MF) i waiho ʻia a me ka hoʻokele GMP i nā mea hana lāʻau lapaʻau kūloko a me nā ʻāina ʻē ma Iapana, ʻo ia mau mea ʻelua i pili kino.

Pono ka lāʻau lapaʻau e hele mua i ka loiloi ʻenehana o MF a hāʻawi i ka nānā GMP o ka kahua hana ma mua o ka loaʻa ʻana o ka ʻae PMDA.Manaʻo ka poʻe i loko o ka ʻoihana ʻo ka hoʻoponopono ʻana o PMDA ka mea koʻikoʻi a ʻoi loa i ka honua, a ʻo ka mālama ʻole ʻana i nā kikoʻī e alakaʻi i ka hoʻopaʻa ʻana o ka loiloi MF a i ʻole ka hāʻule ʻole o ka nānā ʻana o GMP, e pili ana i ka manawa e kūʻai aku ai i nā lāʻau lapaʻau.

ʻO Iapana, aia ma waena o ka 10 kiʻekiʻe e pili ana i ka nui o ka heluna kanaka ma ka honua, ʻo ia ke kolu o ka mākeke lāʻau lapaʻau nui loa a ʻo kekahi o nā lālā koʻikoʻi ʻekolu o ICH (ʻo nā lālā ʻelua ʻo ʻAmelika Hui Pū ʻIa a me ʻEulopa).He lālā ia o ka hui PIC/S.