Ngomhla wama-27 kuTshazimpuzi, 2024 - i-HumanwellCaps iququzelele ikhosi yoQeqesho kuLwazi oluSisiseko lwe-cGMP kubasebenzi bayo ukuze kukhuthazwe uphuhliso oluphezulu{2}}lomgangatho weHumanwellCaps, ukuphumeza isicwangciso seMveliso yokuQala, ukukhawulezisa ubume bezizwe ngezizwe, ukubonelela ngeemveliso ezikumgangatho ophezulu kunye neenkonzo kubathengi basekhaya nabangaphandle, ukuqinisekisa umgangatho kunye nokhuseleko lwemveliso ye-capsule enokubakho kunye nokuphucula umgangatho wemveliso yomngcipheko kunye nokunciphisa umngcipheko wemveliso kunye nomgangatho wemveliso. Ikhosi yathathwa yingcali yolawulo lomgangatho onamava kulo mmandla.
Ukuze kukhuthazwe uphuhliso oluphezulu -lomgangatho weHumanwellCaps, ukuphumeza isicwangciso seMveliso yokuQala, ukukhawulezisa ubume bamazwe ngamazwe, ukubonelela ngeemveliso eziphakamileyo{1}}ezikumgangatho ophezulu kunye neenkonzo kubathengi basekhaya nabangaphandle, ukuqinisekisa umgangatho kunye nokhuseleko lwemveliso yeziyobisi, ukufezekisa injongo yokuphucula ukusebenza kakuhle kunye nomgangatho wemveliso, ukunciphisa ubungozi obunokubakho kunye neempazamo. I-Hubei Renfu Pharmaceutical Excipients Co., Ltd. ibambe "i-cGMP Training Basic Knowledge" ikhosi yoqeqesho esemgangathweni kubo bonke abasebenzi nge-27 ka-Epreli 2024, eyayifundiswe ziingcali zolawulo lomgangatho ophezulu kwishishini.
Usihlalo weHumanwellCaps, u-Huang Jianhua, ugxininise kwintetho yakhe kumsitho wokuvula ukuba umgangatho bubomi beshishini. Ukukhuthaza umsebenzi wokufayilisha we-FDA DMF yindlela eyimfuneko yokuhlangabezana neemfuno zabathengi basekhaya nabangaphandle kumgangatho ophezulu, kwaye ikwayindawo ebalulekileyo yokuqala yokuphucula ngokuthe ngcembe amandla athambileyo amashishini. Ukwakhiwa kwenkqubo esemgangathweni ngokuhambelana neemfuno zamazwe ngamazwe kuhamba kumjikelo wobomi bemveliso, kwaye wonke umqeshwa sisithethi senkampani. Kuyafuneka ngokuqhubekayo ukuphucula izakhono zayo kunye nomgangatho obanzi, ukukholelwa ngokuqinileyo kwingqikelelo yoQeqesho loQeqesho loQeqesho, uTshintsho lokuziphatha, kunye noTshintsho lweNdlela yokuSebenza, ukuthobela ngokungqongqo iimfuno ze-cGMP. NgoMthengi ekuqaleni, ukuba yinkokeli yehlabathi kwicandelo labancedisi bamayeza ukwenza ixabiso kubathengi.
Umxholo woqeqesho ubandakanya ikakhulu i-GMP yaseTshayina (2010), i-US FDA cGMP 21CFR ICANDELO 210 NE-211, EUGMP2008, ICH Q7 Review, ukutolikwa okuneenkcukacha kunye nokusetyenziswa kweminye imimiselo, kunye nophononongo oludityanisiweyo kunye neyona meko yamashishini. Ngelo xesha, iphinda igxininise kwizixhobo eziqhelekileyo kunye neendlela zokuhlalutya eziqhelekileyo kunye neendlela zokulawula umgangatho, ukwenzela ukuba abathathi-nxaxheba babe nokuqonda okunzulu kwinkqubo yethiyori, kodwa kunye nomsebenzi wemihla ngemihla.
Ekupheleni kweseshoni yokufundisa, umqeqeshi woqeqesho unike iimpendulo ezineenkcukacha kwimibuzo yabafundi. Kwangaxeshanye, inkampani iququzelele kwaye iqhube iSeshini yokuCinga kunye noKwabelana malunga noLawulo loBulunga, iinkokeli eziphambili zeHumanwellCaps kunye neentloko zamasebe, abameli babasebenzi kuqeqesho lombono, abasebenzi abaqeqeshiweyo ukuba babelane kwaye baxoxe, ukuze iingcamango kunye nokuqonda kokulawula umgangatho kungene ngakumbi kwingqondo kunye nokuziphatha komsebenzi ngamnye.
