Nūhou

ʻO ke kūlana hoʻokele maikaʻi maikaʻi o ka lāʻau lapaʻau (GMP) a mākou i kamaʻāina ai, ʻo ka hoʻokomo lohi ʻana o EHS i ka GMP, ʻo ia ke ʻano maʻamau.

ʻO ke kumu o ka GMP, ʻaʻole pono wale ka huahana hope e hoʻokō i nā kūlana maikaʻi, akā ʻo ke kaʻina hana holoʻokoʻa pono e hoʻokō i nā koi o GMP, ka hoʻokele ʻenehana kaʻina hana, ka hoʻokele helu batch / batch, ka hoʻopuka a me ka nānā ʻana i ke koena waiwai, mālama olakino, hoʻokele ʻike, hoʻokele deviation e like me ka manaʻo.I kekahi kaʻina hana e pili ana i nā kumu nui o ka maikaʻi o ka huahana (man-machine material ring) e lawe i nā ʻano hana kūpono a pau e pale ai i ka pollution a me ke cross-pollution, huikau a me ka hewa kanaka, e hōʻoia i ka palekana o ka hana lāʻau, e hōʻoia i ka maikaʻi o lāʻau lapaʻau.I Mei 2019, ua hoʻopuka ʻo WHO i nā Environmental Aspects of GOOD Manufacturing Practices: Considerations for Manufacturers and Inspectors i ka pale ʻana i ka pale ʻana i nā antibiotic, me ka mālama ʻana i ka ʻōpala a me ka wai ʻino e like me GMP checkpoints.Ua ʻōlelo ʻia ka pilikia o ka pale ʻana i nā limahana e kākau ʻia i loko o ka GMP hou.ʻO ka pale ʻana i ka pae hoʻolaha ʻoihana (OEB), pono e alakaʻi i ka manaʻo o nā ʻoihana lāʻau!

ʻO nā pōʻino ʻoihana i hoʻokumu ʻia e nā mea hana lāʻau lapaʻau (API) nā kī nui a paʻakikī o ka pale ʻana i ka pōʻino hana a me ka hoʻokele hoʻokele i nā ʻoihana lāʻau.Ma muli o ka pilikia, ʻo nā lāʻau lapaʻau maʻamau a me nā lāʻau ikaika loa, e like me nā lāʻau lapaʻau maʻi maʻi a me ka penicillin, e hoʻohuli nui i ka nānā ʻana, akā ʻaʻole e huki nui nā lāʻau lapaʻau maʻamau ma ka home a ma waho.ʻO ka mea paʻakikī loa, ʻo ia ka waiwai o ka "maʻemaʻe ʻenehana (IH)" o ka mea hoʻoikaika paʻakikī e hoʻoholo a pono e hoʻomaka mai ka toxicology a me ke kauka.Hoʻomaʻamaʻa pinepine ʻia ka pae mana OEB e like me nā hopena hulina MSDS o nā pūhui.Inā hana ʻoe i nā lāʻau lapaʻau hou, pono paha ʻoe e hoʻolilo i kāu kālā ponoʻī a me kou ikaika e hana i ka hoʻāʻo ʻana i ka hana hui pū;No nā lāʻau lapaʻau maʻamau, hiki ke loaʻa nā palena a me nā māka o ka OEL/OEB ma ka nīnau ʻana i ka ʻike MSDS o ka pūhui.Hoʻokaʻawale ʻia nā ana hoʻomalu ʻenehana pili i: 1. Hana wehe;2. Hana pani;3. ʻO ka lako ea holoʻokoʻa;4. Hoʻopau kūloko;5. ʻO ke kahe laminar;6. Mea hoʻokaʻawale;7. Alpha beta valve, etc. ʻOiaʻiʻo, ʻike mākou a pau i kēia mai ke kuanaʻike o GMP, akā ʻo ka hoʻomaka ʻana o ka noʻonoʻo ʻana ma ke ʻano maʻamau mai ke ʻano o ka pale ʻana i ka pollution a me ka hoʻohaumia keʻa, a ʻaʻole loa mai ka ʻike o ka hoʻomaʻemaʻe ʻoihana.

Pono nā ʻoihana lāʻau lapaʻau kūloko e hoʻoikaika i ka pale o nā limahana EHS a hoʻolauna i nā lako hana me ka API OEB grade match.He mea pono ke huki i nā haʻawina mai ka hana maikaʻi ʻana o kekahi mau mea lako lako ʻEulopa a me ʻAmelika i ka pale ʻoihana no kā lākou poʻe limahana, e koi ana i nā faila MSDS kūpono a me ka pale e pili ana i nā palapala hoʻomākaukau no nā huahana hōʻike.I ka wā ma mua, i ka wā i hana ai nā ʻoihana lāʻau lapaʻau kūloko i nā huahana like ʻole e like me ka anesthesia maikaʻi a me ka hoʻokuʻu ʻana i nā toxin, ʻaʻole i paʻa ka pale OEB, kahi i hoʻopilikia ʻia ai ke olakino o nā limahana mua.Ma lalo o ke kūlana i hoʻoikaika mālie ʻia ka ʻike kānāwai o nā limahana, ʻaʻole hiki i nā ʻoihana ke pakele i ke kuleana no nā pōʻino o ka hana.

Ma o ka loiloi pilikia o ka API, ua hāʻawi ʻia ke ʻano helu helu o ka palena hōʻike ʻoihana (OEL), ua hoʻokomo ʻia ka ʻōnaehana hoʻohālikelike API PBOEL, a waiho ʻia nā lula maʻamau e mālama ʻia no ka pale ʻana a me nā hana hoʻomalu.I ka wā e hiki mai ana, e kālailai mākou i ka hoʻolālā hoʻomalu i ka hohonu.E noho mālie!