Isiqinisekiso se-GMP kunye neNkqubo yoLawulo lwe-GMP

Yintoni i-GMP?

I-GMP-Uqheliselo oluLungileyo lokuVelisa

Isenokuthiwa yiNgcebiso yangoku yokuVelisa okuLungileyo (cGMP).

Iindlela zokuSebenza eziLungileyo zokuVelisa zibhekisa kwimithetho nemimiselo yokuveliswa kunye nokulawulwa komgangatho wokutya, iziyobisi kunye neemveliso zonyango. Ifuna ukuba amashishini ahlangabezane neemfuno zomgangatho wezococeko ngokwemathiriyeli ekrwada, abasebenzi, izixhobo kunye nezixhobo, inkqubo yokuvelisa, ukupakishwa kunye nokuthutha. ,ulawulo lomgangatho, njl.njl. ngokwemithetho nemimiselo yesizwe echaphazelekayo, ukwenza iseti yeenkcukacha zokusebenza ezisebenzayo ukunceda amashishini ukuphucula imekobume yococeko lwamashishini, kunye nokufumana iingxaki kwinkqubo yemveliso ngexesha lokuphucula.

Umahluko phakathi kweTshayina kunye namanye amazwe amaninzi ehlabathi kukuba ukusetyenziswa kweziyobisi zabantu kunye nokusetyenziswa kweziyobisi zezilwanyana kwahlukile e-China, eyamkela ukusetyenziswa kweziyobisi zabantu i-GMP kunye neyeza lezilwanyana GMP. kwi-2010 kwaye iphunyezwe ngokusemthethweni inguqu entsha ye-GMP ngo-2011.Uguqulelo olutsha lwesiqinisekiso se-GMP lubeka phambili iimfuno eziphezulu zokuveliswa kwamalungiselelo angenazintsholongwane kunye nee-API.

Ke kutheni le nto iifektri ezininzi zamayeza kufuneka ziphumelele isiqinisekiso se-GMP?

Abavelisi okanye amashishini anesiqinisekiso se-GMP afumana iliso elingqongqo kumasebe kazwelonke afanelekileyo kuthotho lweenkqubo ezinjengokuveliswa kwemveliso kunye novavanyo. Kubathengi, ngumqobo wokulawula umgangatho wemveliso, kwaye ikwalukhuselo lwamashishini ngokwawo, iimveliso zinomgangatho wokulawula ngcono umgangatho wemveliso.

Amashishini anesiqinisekiso se-GMP kufuneka aseke inkqubo yolawulo lomgangatho we-GMP ukuqinisekisa ukuthembeka kunye nokulandeleka komgangatho weshishini, kuba ishishini lifumana rhoqo uphicotho lwe-GMP kuLawulo lweSizwe lokuTya kunye neDrugs rhoqo emva kweminyaka emihlanu ukujonga onke amaxwebhu e-GMP kunye nokusebenza okufanelekileyo. iirekhodi zembali yeshishini kwiminyaka emihlanu edlulileyo.

Njengomzi-mveliso we-GMP,Handeiphumeza ulawulo lomgangatho ngokungqongqo ngokweemfuno ze-cGMP kunye namaxwebhu akhoyo olawulo lomgangatho.ISebe loQinisekiso loMgangatho lilawula ukuphunyezwa komsebenzi osemgangathweni kuwo onke amasebe, kwaye ngokuqhubekayo liphucula kwaye ligqibelelisa inkqubo yolawulo lomgangatho wenkampani ngokuzihlola ngaphakathi kwe-GMP kunye ne-GMP yangaphandle. uphicotho (uphicotho lwabathengi, uphicotho lomntu wesithathu kunye nophicotho lwe-arhente elawulayo).