I-Good Manufacturing Practices okanye i-GMP yinkqubo equlathe iinkqubo, iinkqubo kunye namaxwebhu aqinisekisa ukuba iimveliso zokwenza, ezifana nokutya, izinto zokuthambisa, kunye neemveliso zamayeza, ziveliswa kwaye zilawulwa rhoqo ngokwemigangatho ebekiweyo yomgangatho. Ukusebenzisa i-GMP kunokunceda ukunciphisa ilahleko kunye nenkunkuma, kuthintele ukukhunjulwa, ukuhluthwa, izohlwayo kunye nexesha lokuvalelwa entolongweni. Lilonke, ikhusela inkampani kunye nomthengi kwiziganeko ezimbi zokhuseleko lokutya.
Ii-GMP zihlola kwaye zigubungela yonke into eyenzeka kwinkqubo yokuvelisa ukuze zikhusele naziphi na iingozi ezinokuba yintlekele kwiimveliso, ezinje ngokungcoliswa, ukungcoliswa, kunye nokulebhelishwa ngendlela engafanelekanga. Ezinye iindawo ezinokuchaphazela ukhuseleko kunye nomgangatho weemveliso ezijongwa yisikhokelo kunye nomthetho we-GMP zezi zilandelayo:
·Ulawulo lomgangatho
·Ucoceko kunye nococeko
·Izakhiwo kunye nezibonelelo
·Izixhobo
·Iimpahla ezingekasilwa
·Abasebenzi
·Ukuqinisekiswa kunye neziqinisekiso
·Izikhalazo
·Ukubhala amaxwebhu nokugcina iirekhodi
·Uhlolo kunye nokuhlolwa komgangatho
Yintoni umahluko phakathi kwe-GMP kunye ne-cGMP?
Iindlela Zokuvelisa Ezilungileyo (i-GMP) kunye neendlela Zokuvelisa Ezilungileyo (i-cGMP) zangoku, kwiimeko ezininzi, ziyatshintshana. I-GMP ngumgaqo osisiseko opapashwe yi-US Food and Drug Administration (FDA) phantsi kwegunya le-Federal Food, Drug, and Cosmetic Act ukuqinisekisa ukuba abavelisi bathatha amanyathelo okuqinisekisa ukuba iimveliso zabo zikhuselekile kwaye ziyasebenza. Kwelinye icala, i-cGMP yaphunyezwa yi-FDA ukuqinisekisa ukuphuculwa okuqhubekayo kwindlela abavelisi abafikelela ngayo kumgangatho wemveliso. Oku kuthetha ukuzibophelela rhoqo kwimigangatho ephezulu ekhoyo ngokusebenzisa iinkqubo kunye nobuchwepheshe obuhlaziyiweyo.
Ziziphi izinto ezi-5 eziphambili zeMikhwa emihle yoKwenziwa kweMveliso?
Kubaluleke kakhulu kwishishini lemveliso ukulawula i-GMP kwindawo yokusebenza ukuqinisekisa umgangatho ozinzileyo kunye nokhuseleko lweemveliso. Ukugxila kwezi P zi-5 zilandelayo ze-GMP kunceda ukuthobela imigangatho engqongqo kuyo yonke inkqubo yemveliso.
Ii-P ezi-5 ze-GMP
1. Abantu
Bonke abasebenzi kulindeleke ukuba balandele ngokungqongqo iinkqubo nemigaqo yokuvelisa. Uqeqesho lwe-GMP lwangoku kufuneka lwenziwe ngabo bonke abasebenzi ukuze baqonde ngokupheleleyo imisebenzi yabo kunye noxanduva lwabo. Ukuvavanya ukusebenza kwabo kunceda ekunyuseni imveliso yabo, ukusebenza kakuhle, kunye nobuchule.
2. Iimveliso
Zonke iimveliso kufuneka zivavanywe rhoqo, zithelekiswe, kwaye ziqinisekiswe umgangatho ngaphambi kokuba zisasazwe kubathengi. Abavelisi kufuneka baqinisekise ukuba izinto eziphambili kuquka iimveliso eziluhlaza kunye nezinye izinto zineenkcukacha ezicacileyo kuzo zonke izigaba zemveliso. Indlela eqhelekileyo kufuneka ilandelwe xa kufakwa, kuvavanywa, kwaye kwabelwa iimveliso zesampulu.
3. Iinkqubo
Iinkqubo kufuneka zibhalwe phantsi ngokufanelekileyo, zicace, zihambelane, kwaye zisasazwe kubo bonke abasebenzi. Uvavanyo oluqhelekileyo kufuneka lwenziwe ukuqinisekisa ukuba bonke abasebenzi bayayithobela inkqubo yangoku kwaye bayahlangabezana nemigangatho efunekayo yombutho.
4. Iinkqubo
Inkqubo yiseti yezikhokelo zokwenza inkqubo ebalulekileyo okanye inxalenye yenkqubo ukuze kufunyanwe iziphumo ezifanayo. Kufuneka ichazwe kubo bonke abasebenzi kwaye ilandelwe rhoqo. Nakuphi na ukuphambuka kwinkqubo eqhelekileyo kufuneka kuxelwe ngoko nangoko kwaye kuphandwe.
5. Indawo
Indawo kufuneka ikhuthaze ucoceko ngamaxesha onke ukuze kuthintelwe ukungcoliswa okugqithisileyo, iingozi, okanye nokufa. Zonke izixhobo mazibekwe okanye zigcinwe ngokufanelekileyo kwaye zilinganiswe rhoqo ukuqinisekisa ukuba zifanelekile ngenjongo yokuvelisa iziphumo ezihambelanayo ukuthintela umngcipheko wokungasebenzi kakuhle kwezixhobo.
Zithini iiMigaqo ezili-10 ze-GMP?
1. Yenza iiNkqubo zokuSebenza eziQhelekileyo (ii-SOP)
2. Ukunyanzelisa/ukuphumeza ii-SOP kunye nemiyalelo yomsebenzi
3. Bhala phantsi iinkqubo kunye neenkqubo
4. Qinisekisa ukusebenza kakuhle kwee-SOPs
5. Yila kwaye usebenzise iinkqubo zokusebenza
6. Gcina iinkqubo, izibonelelo, kunye nezixhobo zisemgangathweni
7. Ukuphuhlisa izakhono zomsebenzi zabasebenzi
8. Thintela ungcoliseko ngokucoca
9. Beka umgangatho phambili kwaye udibanise nomsebenzi
10. Yenza uhlolo lwe-GMP rhoqo
Indlela yokuthobela u-GUmgangatho we-MP
Izikhokelo nemigaqo ye-GMP zijongana nemiba eyahlukeneyo enokuphembelela ukhuseleko kunye nomgangatho wemveliso. Ukuhlangabezana nemigangatho ye-GMP okanye ye-cGMP kunceda umbutho ukuba uthobele imiyalelo yomthetho, unyuse umgangatho weemveliso zawo, uphucule ulwaneliseko lwabathengi, unyuse intengiso, kwaye ufumane imbuyekezo enenzuzo yotyalo-mali.
Ukwenza uhlolo lwe-GMP kudlala indima enkulu ekuvavanyeni ukuthobela kombutho imigaqo yokuvelisa kunye nezikhokelo. Ukwenza uhlolo rhoqo kunokunciphisa umngcipheko wokuguqulwa kunye nophawu olubi. Uhlolo lwe-GMP lunceda ukuphucula ukusebenza ngokubanzi kweenkqubo ezahlukeneyo kubandakanya oku kulandelayo:
·Izakhiwo kunye nezibonelelo
·Ulawulo lwezixhobo
·Iinkqubo zokulawula umgangatho
·Ukuvelisa
·Ukupakisha kunye nokubhala iilebheli zokuchonga
·Iinkqubo zolawulo lomgangatho
·Uqeqesho lwabasebenzi kunye ne-GMP
·Ukuthenga
·Inkonzo eyenzelwe
Ixesha lokuthumela: Matshi-29-2023