Ua wehewehe ʻo Eduard Marty o Codols he mau hiʻohiʻona hoʻolālā kūikawā ko nā lako hana lāʻau lapaʻau a me nā lako hoʻomaʻemaʻe lab e pono ai nā mea hana e makaʻala e hōʻoia i ka mālama ʻana.
Hahai nā mea hana lako i nā kūlana koʻikoʻi i ka hoʻolālā ʻana a me ka hana ʻana i nā mīkini hoʻomaʻemaʻe no ka ʻoihana lāʻau lapaʻau. He mea nui kēia hoʻolālā no ka mea ua hāʻawi ʻia nā hiʻohiʻona like ʻole e kūlike me ka Good Manufacturing Practice (nā lako GMP) a me ka Good Laboratory Practice (nā lako GLP).
Ma ke ʻano he ʻāpana o ka hōʻoia ʻana i ka maikaʻi, koi ʻo GMP i ka hōʻoia ʻana ua hana ʻia nā huahana ma ke ʻano like a kāohi ʻia e like me nā kūlana maikaʻi e kūpono i ka hoʻohana ʻana i ka huahana a ma lalo o nā kūlana e pono ai no ke kālepa ʻana. Pono ka mea hana e kāohi i nā mea āpau e pili ana i ka maikaʻi hope loa o ka huahana lāʻau lapaʻau, me ka pahuhopu nui o ka hōʻemi ʻana i ka pilikia i ka hana ʻana o ka huahana lāʻau lapaʻau holoʻokoʻa.
He mea koi nā lula GMP no nā mea hana lāʻau lapaʻau āpau. No nā mea hana GMP, loaʻa i ke kaʻina hana nā pahuhopu kikoʻī hou aʻe:
Aia nā ʻano hana hoʻomaʻemaʻe like ʻole: manual, in-place (CIP) a me nā lako kūikawā. Hoʻohālikelike kēia ʻatikala i ka holoi lima ʻana i ka hoʻomaʻemaʻe ʻana me nā lako GMP.
ʻOiai ʻo ka holoi lima he pono o ka maʻalahi, nui nā pilikia e like me ka manawa holoi lōʻihi, ke kumukūʻai mālama kiʻekiʻe, a me ka paʻakikī i ka hoʻāʻo hou ʻana.
Pono ka mīkini holoi GMP i kahi hoʻopukapuka mua, akā ʻo ka pōmaikaʻi o nā lako, he maʻalahi ke hoʻāʻo a he hana hana hou a kūpono hoʻi no kekahi mea hana, pūʻolo a me nā ʻāpana. ʻAe kēia mau hiʻohiʻona iā ʻoe e hoʻomaikaʻi i ka hoʻomaʻemaʻe ʻana, e mālama ana i ka manawa a me ke kālā.
Hoʻohana ʻia nā ʻōnaehana hoʻomaʻemaʻe aunoa i nā hale hana noiʻi a me nā hale hana lāʻau lapaʻau e hoʻomaʻemaʻe i nā mea he nui. Hoʻohana nā mīkini holoi i ka wai, ka mea holoi a me ka hana mechanical e hoʻomaʻemaʻe i nā ʻili mai nā ʻōpala hale hana a me nā ʻāpana ʻoihana.
Me ka nui o nā mīkini holoi no nā noi like ʻole ma ka mākeke, kū mai kekahi mau nīnau: He aha ka mīkini holoi GMP? Āhea wau e pono ai i ka hoʻomaʻemaʻe lima a āhea wau e pono ai i ka holoi GMP? He aha ka ʻokoʻa ma waena o nā gaskets GMP a me GLP?
ʻO ke poʻo inoa 21, nā ʻĀpana 211 a me 212 o ke Code of Federal Regulations (CFR) o ka US Food and Drug Administration e wehewehe ana i ke ʻano hoʻoponopono e pili ana i ka mālama ʻana i nā lāʻau lapaʻau GMP. ʻO ka Māhele D o ka Māhele 211 e komo pū ana me ʻelima mau ʻāpana e pili ana i nā lako a me nā mīkini, me nā gaskets.
Pono e noʻonoʻo ʻia ka 21 CFR Māhele 11 e pili ana i ka hoʻohana ʻana i nā ʻenehana uila. Ua māhele ʻia i ʻelua mau ʻāpana nui: ka hoʻopaʻa inoa uila a me ke kau inoa uila.
Pono nā lula FDA no ka hoʻolālā a me ka hana ʻana o nā mea hana e mālama i nā alakaʻi i lalo:
Hiki ke hoʻokaʻawale ʻia nā ʻokoʻa ma waena o nā mīkini holoi GMP a me GLP i kekahi mau ʻano, akā ʻo ka mea nui loa, ʻo ia kā lākou hoʻolālā mīkini, palapala, a me nā polokalamu, automation a me ka kaohi kaʻina hana. e ʻike i ka papa.
No ka hoʻohana pono ʻana, pono e kuhikuhi pololei ʻia nā mea holoi GMP, e pale ana i nā koi kiʻekiʻe a i ʻole nā ​​mea i kū ʻole i nā kūlana hoʻoponopono. No laila, he mea nui e hāʻawi i kahi Kikoʻī Koi Mea Hoʻohana kūpono (URS) no kēlā me kēia papahana.
Pono nā kikoʻī e wehewehe i nā kūlana e hoʻokō ʻia, ka hoʻolālā mīkini, nā kaʻina hana, nā polokalamu a me nā ʻōnaehana kaohi, a me nā palapala e pono ai. Pono nā alakaʻi GMP i nā ʻoihana e hana i kahi loiloi pilikia e kōkua i ka ʻike ʻana i nā mīkini holoi kūpono e hoʻokō i nā koi i kuhikuhi mua ʻia.
Nā Gaskets GMP: Ua ʻāpono ʻia nā ʻāpana hoʻopaʻa paʻa a pau e ka FDA a ʻo nā paipu a pau he AISI 316L a hiki ke hoʻokahe ʻia. E hāʻawi i ka kiʻikuhi uwea mea hana piha a me ke ʻano e like me GAMP5. Ua hoʻolālā ʻia nā kaʻa kūloko a i ʻole nā ​​​​haka o ka mea holoi GMP no nā ʻano ʻāpana hana āpau, ʻo ia hoʻi nā mea hana, nā pahu, nā ipu, nā ʻāpana laina ʻōmole, ke aniani, a pēlā aku.
Nā Gaskets GPL: Hana ʻia mai ka hui pū ʻana o nā ʻāpana maʻamau i ʻae hapa ʻia, nā paipu paʻa a palupalu, nā kaula a me nā ʻano gaskets like ʻole. ʻAʻole hiki ke hoʻokahe ʻia nā paipu āpau a ʻaʻole kūlike kā lākou hoʻolālā me GAMP 5. Ua hoʻolālā ʻia ka trolley kūloko GLP no nā ʻano mea hana hoʻokolohua āpau.
Mālama kēia pūnaewele i nā ʻikepili e like me nā kuki no ka hana o ka pūnaewele, me ka analytics a me ka hoʻopilikino ʻana. Ma ka hoʻohana ʻana i kēia pūnaewele, ʻae ʻoe i kā mākou hoʻohana ʻana i nā kuki.