pae o nā kikoʻī
Ma USA, ua uhi ʻia nā loina o GMP ma ka ʻāpana 210 a me ka ʻāpana 211 o ke code o nā lula federal.No ka paʻakikī o kēia mau lula e hoʻololi a hoʻohui ʻia, ua hoʻokuʻu ʻo FDA i nā palapala like ʻole o nā lula GMP a me nā alakaʻi hana no nā lāʻau lapaʻau, e like meAlakaʻi no ka ʻoihana.ʻO kēia mau faila i hoʻololi mau ʻia a hoʻohui ʻia i kapa ʻia nā alakaʻi alakaʻi CGMP.ʻO kekahi o kēia mau alakaʻi e pili ana i ka noiʻi lāʻau hou a me ka hoʻopaʻa inoa ʻana, e like me ICH (Q1-Q10).Pehea e hoʻokō ai i ka hōʻoia ʻana o ke kaʻina hana, ka hōʻoia kaʻina hana a me nā mea ʻē aʻe e pili ana i ka GMP i hoʻokomo pū ʻia i loko o kēia mau palapala, ʻo ia nā kūlana i hoʻokō ʻia i ka nānā ʻana ma ka pūnaewele GMP.Eia kekahi, ua hoʻokuʻu ʻia kekahi mau alakaʻi no nā mea nānā GMP ma ke ʻano he kuhikuhi, e like meAlakaʻi no ka nānā ʻana i nā mea hana lāʻau lapaʻau ma ka palapala dosis, Alakaʻi no ka nānā ʻana i nā ʻōnaehana maikaʻi, Hōʻoia i nā kaʻina hana hoʻomaʻemaʻeetc. ʻAʻole koi ʻia ka hoʻohana ʻana i kēia mau alakaʻi.No ka mea ʻo nā mea nānā FDA wale nō i ʻae ʻia e hoʻoholo inā hoʻokō ke kaʻina hana o ka mea hana i kēia maʻamau "i kēia manawa", pono nā mea hana lāʻau e hahai i ka cGMP hou loa a me nā alakaʻi ʻē aʻe a nānā iā lākou iho e ʻike inā ua mālama ʻia nā kūlana.A i ʻole, e manaʻo ʻia lākou he "ʻaʻole ʻae ʻia" a hoʻopaʻi ʻia no ia.
ʻO ka GMP Kina (1998 paʻi) he maʻalahi loa a maopopo ʻole, nele i nā alakaʻi kuhikuhi a me nā koi e like me nā kumu GMP.Ma ka appendix o 1998 paʻi GMP, ʻeono ʻano lāʻau i lawe ʻia me nā alakaʻi pōkole.I kēia manawa, ʻaʻohe hakahaka i ka GMP e hāʻawi ana i nā kuhikuhi alakaʻi hana.ʻO ka hōʻoia a me ka hōʻoia ʻana o nā lako, ka hōʻoia ʻana i ke kaʻina hana, ka hōʻoia ʻana i ke ʻano, ka hōʻoia sterilization a me nā ʻano hana kikoʻī ʻē aʻe i hana ʻia me ka ʻole o nā kūlana kikoʻī, e kumu i ka hoʻokele hope.
E hoʻouna i kāu leka iā mākou:
Ka manawa hoʻouna: Nov-03-2017