ʻO GMP (Good Manufacturing Practice) kahi alakaʻi i manaʻo ʻia e kāohi a nānā i nā hana hana lāʻau lapaʻau ma ka honua holoʻokoʻa.He ʻae kūpono hoʻi ia no nā mea hana lāʻau lapaʻau e komo i ke kahua o ke kālepa honua.
ʻO ka GMP nā: hale, kanaka, kahua, maʻemaʻe, hōʻoia, palapala, hana, maikaʻi, kūʻai, hoʻohana hou a nānā a me nā mea ʻē aʻe. nā lāʻau lapaʻau ʻē aʻe, ka hoʻololi ʻana a me ka haʻalele ʻana mai ka hui ʻana o nā ʻāpana like ʻole, nā ulia o ka nalo ʻana o nā ʻanuʻu o ka nānā ʻana, nā hana hewa a me nā kaʻina hana ʻē aʻe.
Ua hāpai ʻia ka manaʻo o GMP i ka makahiki 80 o Kina a ua hoʻolaha ʻia ʻo ia ka hoʻoponopono piha a koi ʻia ma Iulai 1.st, 1999. Ma USA, ua hoʻokuʻu ʻia ka cGMP (pōkole no Current Good Manufacture Practices) ma CFR ʻāpana 210 a me ka hapa 211 i nā makahiki 90.
ʻO ka holoʻokoʻa, ʻo ke kumu, ka loina, ke kumuhana a me nā koi o ka GMP Kina ua aneane like me ko ʻAmelika cGMP akā he nui maoli nā ʻokoʻa e like me kēia.
Kaʻina hana o ka ʻae ʻana
ʻO ka palapala hōʻoia o ka GMP Kina he palapala hōʻoia wale nō no ka ʻae ʻana i ka hana lāʻau lapaʻau, me ka ʻole o ka hoʻopaʻa inoa huahana.Ma hope o ka ʻae ʻia ʻana o ka mea hana no ka huahana hou me kahi helu hoʻopaʻa inoa, hiki iā ia ke hoʻomau i ka noi o ka palapala GMP.Eia kekahi, ʻo ka ʻikepili o ʻekolu mau pūʻulu o ka hana a me ka ʻikepili o ka loiloi kūpaʻa i ka liʻiliʻi o ʻeono mahina e koi ʻia no ka hoʻopaʻa inoa huahana a i ʻole ka palapala GMP.
ʻO ka palapala hōʻoia o ʻAmelika cGMP he ʻelua mau ʻāpana: Hoʻomohala Huahana a me ka Mana Hana Hana Hana.ʻO ia hoʻi ke hoʻomau nei ka hoʻopaʻa inoa hana a me ka ʻae hana i ka manawa like.ʻElua ʻano o ka hoʻopaʻa inoa huahana ma USA: New Drug Application (NDA) a me Abbreviated New Drug Application (ANDA).Pono ʻo NDA i ka ʻikepili o ʻekolu pūʻulu hana a me ka ʻikepili o ka loiloi kūpaʻa i loko o ʻeono mahina.Pono ʻo ANDA i ka ʻikepili o kahi pūʻulu hana a me ka ʻikepili o ka loiloi kūpaʻa i ʻekolu mahina.E mālama ʻia ka ʻikepili o ka loiloi mau a me ka hōʻoia ʻana e ka mea hana a haʻi ʻia ma ka hōʻike makahiki i FDA.
E hoʻouna i kāu leka iā mākou:
Ka manawa hoʻouna: Oct-27-2017