Iimilinganiselo ezincinane ze-FDA
Ngaloo nyaka, wabhala uJohan P. Swann, umbhali-mlando we-FDA, i-Winthrop Chemical Inkampani yaseNew York yaqalisa ukuthengisa izibhebhile ezingcolileyo ezazikhokelela ekukhulaleni kweemali kunye nokufa.
Uphando lwe-FDA lweWinthrop lubonakalise ukungaphumeleli okukhulu kwezi ndawo kunye nobunzima beenkampani ekukhunjuleni iimveliso ezingcolileyo. I-World Health Organisation (i-WHO) yaqulunqa iinkqubo zayo ezilungileyo zokuvelisa nokuvelisa umgangatho weziyobisi ngo-1967 kwaye yamukelwa kamva kwiNdibano yezeMpilo yehlabathi le-20.
Iindlela ezikhoyo ezilungileyo zokuThengisa eMelika
E-United States, i-Current Good Good Manufacturing Practices, okanye i-CGMP, yimimiselo esemthethweni ye-FDA equkethwe kwimimiselo kunye nemigaqo-nkqubo kunye neenkxalabo zokuyila, ukubeka esweni nokulawula iinkqubo zokuvelisa kunye nezibonelelo. Ukongezwa kwe "okwangoku" kukhumbuza abakhiqizi ukuba kufuneka basebenzise ubuchwepheshe beendlela kunye neenkqubo ukwenzela ukuba bahambisane nemimiselo.
I-FDA idinga ukuba abavelisi bamachiza balandele kule migaqo eqinisekisa isiqinisekiso semveliso yeziyobisi, amandla, umgangatho kunye nokuhlanzeka.
Abanye abavelisi bamachiza baye bamisela iinkqubo zobuncitshisi kunye nobungozi obugqithisileyo kumgangatho we-cGMP.
Ukuhambela kwi-cGMP kufuna abavelisi ukuba bazise iinkqubo zokulawula imgangathiso, bafumane izinto ezibonakalayo eziphezulu, basebenzise iinkqubo zokusebenza, bafumane kwaye baphande iingxaki ezinokubaluleka kwemveliso, kwaye balondoloze ii-laboratories ezinokuzithemba.
I-FDA inamagunya okulawula ukuhlola izityalo zokuvelisa izixhobo zamachiza ukuthotyelwa kweCGMP.
Uhlolo lwe-FDA lweziko lokuvelisa imveliso lubandakanya ukuvavanywa nokuba isibonelelo silandela imigaqo yeCGMP. Ukuhlolwa kungahle kwenzeke ngokungaqhelekanga okanye kunokubangelwa yimicimbi yeemeko ezimbi ezivela kuluntu okanye kumashishini.
Ukuba uMenzi ufunyanwa engekho-Uyahambelana neMimiselo yeCGMP
Ukuba kulandela ukuhlolwa kwe-FDA, umenzi ufumaneka engavumelani nemimiselo yeCGMP, i-FDA iya kukhupha ifomu 483 apho inkampani kufuneka iphendule ngcaciso, okanye xa kuyimfuneko, amanyathelo okulungisa amanyathelo. "Le nkqubo ehlelekile yokulawula kwiinkampani zonyango, ukuba isetyenziswe ngokwaneleyo, inceda ukukhusela iziganeko zokungcola, ukuxuba, ukuchithwa, ukungaphumeleli kunye neeposiso," ngokutsho kwe-FDA.
Imigaqo yeCGMP, amaxwebhu okhokelo kunye nezinye izixhobo zokuncedisa iinkampani zamachiza zihambelanayo nomthetho ziya kufumaneka kwiwebhusayithi ye-FDA, kunye nabameli be-FDA amashishini amancinci, iiOfisi zesiThili, nakwiziko loVavanyo loPhando kunye noPhando, i-Office of Compliance , ISahlulo soPhuhliso kunye neMveliso yoMgangatho. Utshintsho kwimimiselo kunye nokuhlaziywa kwamaphepha okhokelo kwakhona kupapashwe kwiRejista yeSithili.
Xa iNkampani idlwengula iCGMP
Ngelixa i-FDA ingenalo igunya lokufuna inkampani ukuba ikhumbule isilwanyana xa ukhuseleko lweziyobisi lusizo, iinkampani ziyakhumbula ngokuzithandela okanye kwisicelo se-FDA. Ukuba inkampani ayivumelani ukukhumbula isilwanyana, i-FDA inokukhupha isilumkiso esidlangalaleni malunga neziyobisi kunye nokubamba iziyobisi kwaye zisuswe kwiimarike. Ngokutsho kwe-FDA, "Nangona iziyobisi zingenasiphene, i-FDA inokuzisa ukutshatyalaliswa okanye inkundla yamatyala enkundleni ukujongana nokuphulwa kwe-cGMP."
Iimveliso Zamazwe Olungileyo Ezobugcisa
- I-Health Canada: Iimpawu zokuThengisa kakuhle
- IKhomishini yaseYurophu: Izikhokelo ze-GMP
- Umbutho wezeMpilo weHlabathi: WHO Practice Practices Practices
- Amachiza kunye neMpilo yeeMveliso zoLawulo lweMpilo (i-MHRA-UK): UkuCwangcisa okulungileyo
Imizekelo yeeNkqubo kunye noQeqesho oluPhiweyo kwiimfuneko zeCGMP
- Isondlo, ukulinganiswa nokuqinisekiswa kwezixhobo
- Isimo seziko
- Iziqinisekiso kunye noqeqesho lwabasebenzi
- Ukuthembeka nokuveliswa kweenkqubo
- Indlela yokuqinisekisa yokusetyenziswa
- Ukuphathwa kwezikhalazo