Isingeniso kwiiNkqubo eziPhezulu zokuThengiswa kweMveliso (cGMP)

I-FDA, i-CGMP i-Essential to Success Business

E-United States, i-Current Good Good Manufacturing Practices (cGMP) yiMigaqo yokuSebenza yokuTya kunye neDrama (i-FDA) ngokumalunga nokuyila, ukubeka iliso, ukulawula, nokugcinwa kweenkqubo kunye neendawo zokuvelisa. Igama elithi "yangoku" longezelelwe kwiinkcazo kwiinkampani ezifunekayo ukuba zihlale zihlala kunye nobuchwephesha bokwenza ubuchwepheshe, zingathembeli kwinto efanelekileyo eyiminyaka elishumi edlulileyo.

i-CGMP ilandelwa ngamashishini anokwelapha kunye ne-biotechnology ukuqinisekisa ukuba izinto zabo zenziwa kwiimfuno ezithile ezibandakanya ubunikazi, amandla, umgangatho kunye nokuhlanzeka. Izenzo zokuThengisa kakuhle zilawulwa yi-Food and Drug Administration (FDA).

Kukho imimiselo yemigaqo-nkqubo ephathelene neCGMP, ukuba ingayilandelwa, inokukhokelela kwizigwebo zobugebengu. Kukho imimiselo emibini ehambelana nabavelisi bamachiza, enye yemveliso yezinto eziphilayo, kunye nommiselo olawula iirekhodi zekhompyutheni kunye neesayineli zekhompyutha.

Ngaphandle kokulumkisa, ezinye iinkampani ziye zakhetha ukufumana iinkqubo, iinkqubo kunye neenkqubo zokulawulwa kwengozi ehamba ngaphezulu nangaphezulu kwemigaqo yeCGMP.

I-Code of Regulations Federal (CFR)

I-Code of Regulations Regulations (CFR) yi-codification yemithetho jikelele kunye neyigxina yeburhulumente karhulumente. I-CFR iqulethe itekisi epheleleyo kunye neyosemthethweni yemimiselo enyanzeliswa yi-arhente karhulumente.

I-CFR idibene ngamagama angama-50 abonisa indawo ephakamileyo ngokwemiqathango yaseStar. Isihloko ngasinye sahlula izahluko ezabiwe kwii-arhente ezahlukileyo ezikhupha imimiselo ephathelele kulo mbandela. Isahluko ngasinye sahlula sibe yiindawo ezinxulumene nemimandla ethile yokulawula. Inxalenye nganye okanye isahlulo sesahlulo siyahlukana ibe ngamacandelo - iyunithi eyisiseko yeCFR.

Ngamanye amaxesha amacandelo anqatshelwe ngakumbi kumhlathi okanye kwicandelwana. Izicatshulwa ezinxulumene nolwazi oluthile kwiCFR ziya kufakwa kwinqanaba lecandelo.

CGMP kunye neShishini seMveliso

I-CFR ezinxulumene neCGMP kwiinkampani zonyango kunye ne-biotechnology zi:

• 21 CFR Ingxenye 210 - Ulungelelaniso olulungileyo lokuThengiswa koBuchule, ukuCwangcisa, ukuPakisha okanye ukuThengiswa kweziDakamizwa; Jikelele Ingxenye
• 21 CFR Icandelo 211 - Ulungelelaniso olulungileyo lokuThengiswa kweeMveliso zeMichiza
• 21 CFR Ingxenye 600 - IiMveliso zeBiyoloji: Jikelele
• 21 CFR Icandelo 11 - IiRekhodi zeeFom. Izityikityo zeeMbane

Ngokubanzi, i-21 CFR Ingxenye 210 ilawula i-cGMP yokuvelisa, ukucubungula, ukupakisha, okanye ukugcina iziyobisi. Icandelo 210 liquka iinkcazelo ezisetyenziswe kwimimiselo efana nebheki, inkalo, njl njl.

I-21 CFR Ingxenye 211 ye-cGMP yeeyeza ezigqityiweyo. Ngokomzekelo, iyeza elinobisi olusisigxina kwisibambiso seplastiki laliza kuhlanganiswa yiNgxenye 210, kodwa iipilisi ezahlukileyo emva kokuba iinqanawa ziyakuthi zihlanganiswe yiCandelo 211.

21 I-CFR Ingxenye 600 inxulumene neMveliso yeBiological and iqulethe iinkcazelo eziphambili, imilinganiselo yokusekwa, iimfuno zokuhlola izilwanyana kunye neemfuno zokuvavanya amava.

21 CFR Ingxenye 11 iqulethe izikhokelo kwiirekhodi zekhompyutheni kunye nokusayina ngekhompyutha. ISahluko 11 sichaza imigaqo ephantsi kwayo iirekhodi zekhompyutheni kunye neesayinithi zecomputer zibhekwa njengezithembekileyo, ezithembekileyo kwaye zilingana neerekhodi zamaphepha. Icandelo 11 lisebenza nakwiimviwo ezenziwe kwi-FDA kwifomathi yekhompyutha.