Hoʻoponoponoʻia e ka FDA, nā CGMPs he mea nui i kaʻoihanaʻoihana
ke kāpiliʻia nei nā hui o ka lāʻau pīpī a me kaʻoihanaʻenehana e ka mea e hoʻokomoʻia ai kā lākou mau mea e like me kaʻike, ka ikaika, ka maikaʻi, a me ka maʻemaʻe. Hoʻoponoponoʻia nā hana kūikawā maikaʻi e ka Food and Drug Administration (FDA).
He nui nā kānāwai o ke aupuni e pili ana i ka CGMP, ināʻaʻole i hahaiʻia, hiki ke alakaʻi i ka hoʻopaʻi hewa. ʻElua mau rula pili e pili ana i nā mea hana lima hana lāʻau, hoʻokahi no nā meaola biological, a me kahi hoʻoponopono e hoʻoponopono ai i nā leka uila me nā inoa inoa o ka leka.
I ka nui o ka mālamaʻana, ua hoʻoholo kekahi mauʻoihana e hana i nā hana, nā kaʻina hana a me nā'ōnaehana hoʻolālā kūlana e hele i luna a ma waho o nā kānāwai o ka cGMP.
Ka Code o Federal Regulatory (CFR)
ʻO ke Code of Federal Regulatory (CFR) he hoʻololiʻana i nā rula kauā a paʻa loa o ke aupuni aupuni. Aia ka CFR i ka pepa piha a me ka mana o nā rula e hoʻokōʻia e nā keʻena aupuni.
Ua puʻunaueʻia ka CFR i 50 mau pane e hōʻike ana i nā wahi ākea i pili i nā kānāwai o Federal. Hoʻokaʻawaleʻia kēlā me kēia māhele i nā mokuna i hāʻawiʻia i nā keʻena likeʻole e hoʻopuka ana i nā rula e pili ana i kēlā mehua. Hoʻokaʻawaleʻia kēlā me kēia māhele i nā'āpana e uhi ana i nā māhele kūpono. E puʻunaueʻia kēlā me kēia māhele a māhele paha i nā paukū - ka māhele papa o ka CFR.
I kekahi manawa, e mahele houʻia nā paukū i loko o nā paukū a iʻole nā pauku. ʻO nā kūmole e pili ana i nāʻike kūikawā i ka CFR e hoʻolakoʻia ma ka paukū o ka pae.
CGMP a me ke Keʻena Hana Hana
ʻO nā CFR e pili ana i ka CGMP ma nāʻoihana kāmahana a me nāʻoihanaʻenehana:
- 21 CFR Māhele 210 - Ka Hana Hana Maʻemaʻe o nā Hana i kēia manawa, Hanaʻana, Hoʻopiliʻana, a iʻole paʻaʻana o nā lāʻauʻawa; Māhele nui
- 21 CFR Māhele 211 - Ka Hana Hana Kūʻai Loa Loa Loa no nā Hana Kūʻai'Āina
- 21 CFR Māhele 600 - Nā Hua Ola Ola: Nui
- 21 CFR Māhele 11 - Electronic Records; Nā inoa inoaʻeleʻele
Ma keʻano laulā, 21 CFR Māhele 210 e hoʻomalu i ka cGMP no ka hana, ka hanaʻana, ka hōʻailona, a me ka paʻaʻana i nā lāʻau lapaʻau. Mahele 210 ka'ōlelo i hoʻohanaʻia i loko o nā rula e like me ka pahu, ka pahu, a pēlā aku.
ʻO ka 21 CFR Māhele 211 no CGMP ia no nā mea lapaʻau. Eia kekahi laʻana, e uhiʻia kahi leka wai lāʻau ma loko o kahi pahu'ilika e ka Māhele 210, akā, hiki paha ke uhiʻia i kahi puʻupuʻu ma hope o ka moku i ka Māhele 211.
21 CFR Māhele 600 e pili ana i nā Hua Ola Ola a loaʻa i nā manaʻo nui, nā papahana kūkulu, nā mea e nānāʻia ai nā hale hoʻolālā a me nā pono hōʻike hōʻike kūpono.
21 CFR Mahele 11 kahi i nā kulekele ma nā leka uila a me nā inoa inoaʻeleʻele. Mahele 11 ua ho'ākāka i nāʻano hoʻohālikelike i manaʻoʻia he mau hiʻona a me nā inoa o ka leka uila e like me nā moʻolelo pepa. Māhele 11 hoʻi pili i nā noi i hanaʻia i ka FDA ma ka palapala'elepona.