IiNdlela zokuSebenza eziLungileyo zoMveliso okanye i-GMP yinkqubo eneenkqubo, iinkqubo kunye namaxwebhu aqinisekisa ukuba iimveliso zokuvelisa, ezifana nokutya, izinto zokuthambisa, kunye neempahla zamayeza, zisoloko ziveliswa kwaye zilawulwa ngokwemigangatho ebekiweyo yomgangatho.Ukuphumeza i-GMP kunokunceda ukunciphisa ilahleko kunye nenkcitho, ukuphepha ukukhumbula, ukubanjwa, izohlwayo kunye nexesha lokuvalelwa entolongweni.Ngokubanzi, ikhusela inkampani kunye nomthengi kwimisitho engalunganga yokhuseleko lokutya.
Ii-GMPs zihlola kwaye zigqume yonke inkalo yenkqubo yokwenziwa kwemveliso ukugada kuyo nayiphi na imingcipheko enokuba yintlekele kwiimveliso, ezinje ngongcoliseko olunqamlezayo, ukukrexeza, kunye nokubhalwa kakubi.Ezinye iindawo ezinokuphembelela ukhuseleko kunye nomgangatho weemveliso isikhokelo se-GMP kunye nedilesi yommiselo zezi zilandelayo:
·Ulawulo lomgangatho
·Ucoceko kunye nococeko
·Isakhiwo kunye nezibonelelo
·Izixhobo
·Iimpahla ezingekasilwa
·Abasebenzi
·Ukuqinisekiswa kunye nesiqinisekiso
·Izikhalazo
·Amaxwebhu kunye nokugcinwa kweerekhodi
·Uhlolo nophicotho-zincwadi olusemgangathweni
Yintoni umahluko phakathi kwe-GMP kunye ne-cGMP?
IiNdlela eziLungileyo zokuVelisa (i-GMP) kunye neZiqhelo zokuVelisa eziLungileyo zangoku (cGMP), kwiimeko ezininzi, ziyatshintshana.I-GMP ngummiselo osisiseko owabhengezwa yi-US Food and Drug Administration (FDA) phantsi kwegunya leFederal Food, Drug, and Cosmetic Act ukuqinisekisa ukuba abavelisi bathatha amanyathelo okuqinisekisa ukuba iimveliso zabo zikhuselekile kwaye ziyasebenza.I-cGMP, kwelinye icala, yaphunyezwa yi-FDA ukuqinisekisa ukuphuculwa okuqhubekayo kwindlela abavelisi kumgangatho wemveliso.Oku kuthetha ukuzinikela okuthe gqolo kweyona migangatho iphezulu yomgangatho ifumanekayo ngokusetyenziswa kweenkqubo ezihlaziyiweyo kunye nobuchwepheshe.
Ngawaphi aMalungu ama-5 angundoqo oQeqesho oluLungileyo lweMveliso?
Kubaluleke kakhulu kwishishini lokuvelisa ukulawula i-GMP kwindawo yokusebenza ukuze kuqinisekiswe umgangatho ongaguqukiyo kunye nokhuseleko lweemveliso.Ukujolisa kwezi 5 P zilandelayo ze-GMP kunceda ukuthobela imigangatho engqongqo kuyo yonke inkqubo yemveliso.
IiPs ezi-5 ze-GMP
1. Abantu
Bonke abasebenzi kulindeleke ukuba babambelele ngokungqongqo kwiinkqubo nemimiselo yokwenziwa kwemveliso.Uqeqesho lwangoku lwe-GMP kufuneka lwenziwe ngabo bonke abasebenzi ukuze baqonde ngokupheleleyo iindima noxanduva lwabo.Ukuvavanya ukusebenza kwabo kunceda ukukhulisa imveliso yabo, ukusebenza kakuhle, kunye nobuchule.
2. Iimveliso
Zonke iimveliso kufuneka zihlale zivavanywa, zithelekiswe, kunye nokuqinisekiswa komgangatho ngaphambi kokuba zihanjiswe kubathengi.Abavelisi kufuneka baqinisekise ukuba imathiriyeli yokuqala ebandakanya iimveliso ezikrwada kunye namanye amacandelo anengcaciso ecacileyo kwinqanaba ngalinye lemveliso.Indlela esemgangathweni kufuneka iqwalaselwe ukupakisha, ukuvavanywa, kunye nokwabiwa kweemveliso zesampulu.
3. Iinkqubo
Iinkqubo kufuneka zibhalwe ngokufanelekileyo, zicace, zingaguquguquki, kwaye zisasazwe kubo bonke abasebenzi.Uvandlakanyo lwarhoqo kufuneka lwenziwe ukuze kuqinisekiswe ukuba bonke abasebenzi bayayithobela le nkqubo yangoku kwaye bayayifezekisa imigangatho efunekayo yombutho.
4. Iinkqubo
Inkqubo yiseti yezikhokelo zokwenziwa kwenkqubo ebaluleke kakhulu okanye inxalenye yenkqubo yokufumana isiphumo esingaguqukiyo.Kufuneka ichazwe kubo bonke abasebenzi kwaye ilandelwe rhoqo.Nakuphi na ukutenxa kwinkqubo emiselweyo kufuneka kuxelwe ngoko nangoko kwaye kuphandwe.
5. Iindawo
Izakhiwo kufuneka zikhuthaze ucoceko ngalo lonke ixesha ukuthintela ukungcoliseka, iingozi, okanye nokufa.Zonke izixhobo kufuneka zibekwe okanye zigcinwe ngokufanelekileyo kwaye zilinganiswe rhoqo ukuqinisekisa ukuba zifanelekile ngenjongo yokuvelisa iziphumo ezihambelanayo zokuthintela umngcipheko wokungaphumeleli kwezixhobo.
Yeyiphi iMigaqo eli-10 ye-GMP?
1. Yenza iiNkqubo zokuSebenza eziMgangatho (SOPs)
2. Ukunyanzelisa / Ukusebenzisa ii-SOP kunye nemiyalelo yomsebenzi
3. Iinkqubo zoxwebhu kunye neenkqubo
4. Qinisekisa ukusebenza kwe-SOPs
5. Yila kwaye usebenzise iinkqubo zokusebenza
6. Gcina iinkqubo, amaziko, kunye nezixhobo
7. Ukuphuhlisa ubuchule bomsebenzi wabasebenzi
8. Thintela ukosuleleka ngococeko
9. Beka phambili umgangatho kwaye udibanise ekuhambeni komsebenzi
10.Ukuqhuba uphicotho lwe-GMP rhoqo
Uhambelana njani noGumgangatho weMP
Izikhokelo kunye nemigaqo ye-GMP ijongana nemiba eyahlukeneyo enokuthi ibe nefuthe kukhuseleko kunye nomgangatho wemveliso.Ukudibana nemigangatho ye-GMP okanye ye-cGMP inceda umbutho ukuba uthobele imiyalelo yowiso-mthetho, unyuse umgangatho weemveliso zabo, uphucule ukwaneliseka kwabathengi, unyuse intengiso, kwaye ufumane imbuyekezo enengeniso kutyalo-mali.
Ukuqhuba uphicotho lwe-GMP kudlala indima enkulu ekuvavanyeni ukuthotyelwa kombutho kwiiprothokholi zokwenziwa kunye nezikhokelo.Ukwenza iitshekhi rhoqo kunokunciphisa umngcipheko wokukrexeza kunye ne-misbrand.Uphicotho lwe-GMP lunceda ukuphucula ukusebenza ngokubanzi kweenkqubo ezahlukeneyo kubandakanya oku kulandelayo:
·Isakhiwo kunye nezibonelelo
·Ulawulo lwezixhobo
·Iinkqubo zokulawula umgangatho
·Ukwenziwa
·Ukupakishwa nokuphawulwa kophawu
·Iinkqubo zolawulo lomgangatho
·Uqeqesho lwabasebenzi kunye neGMP
·Ukuthenga
·Inkonzo eyenzelwe
Ixesha lokuposa: Mar-29-2023