Umgangatho wolawulo lomgangatho wokwenziwa kwamachiza (GMP) esiqhelene nawo, ukufakwa ngokuthe ngcembe kwe-EHS kwi-GMP, yindlela eqhelekileyo.
Ingundoqo ye-GMP, ayifuni kuphela imveliso yokugqibela ukuhlangabezana nemigangatho yomgangatho, kodwa nayo yonke inkqubo yokuvelisa kufuneka ihlangabezane neemfuno ze-GMP, ulawulo lweteknoloji yenkqubo, i-batch / i-batch yolawulo lwenombolo, ukukhutshwa kunye nokuhlolwa kwezinto eziphathekayo, ulawulo lwezempilo, ulawulo lokuchongwa, ulawulo lokutenxa njengogxininiso.Kuyo nayiphi na inkqubo echaphazela imiba ephambili yomgangatho wemveliso (isixhobo somntu-umatshini) ukuthatha zonke iintlobo zamanyathelo asebenzayo ukuthintela ungcoliseko kunye nongcoliseko olunqamlezayo, ukudideka kunye nempazamo yomntu, ukuqinisekisa ukhuseleko lwemveliso yeziyobisi, ukuqinisekisa umgangatho wemveliso. iziyobisi.NgoMeyi ka-2019, i-WHO yapapasha iMiba yokusiNgqongileyo yeNdlela eziLungileyo zoMveliso: Iingqwalasela kuBavelisi kunye nabahloli kuthintelo lokunganyangeki ngamayeza okubulala iintsholongwane, kubandakanya inkunkuma kunye nonyango lwamanzi amdaka njengeendawo zokukhangela ze-GMP.Umba wokhuseleko lwabasebenzi ukwanamarhe okuba ubhalwe kwi-GMP entsha.Ukhuseleko lwenqanaba lokuchasa emsebenzini (OEB), kufuneka lubangele ingqwalasela yamashishini axuba amayeza!
Iingozi zomsebenzi ezibangelwa izithako ezisebenzayo zamachiza (API) zingundoqo kunye namanqaku anzima okuthintela ubungozi bomsebenzi kunye nolawulo lolawulo kumashishini amayeza.Ngokusekelwe kumngcipheko, amachiza amatsha ngokubanzi kunye namachiza asebenzayo kakhulu, njengamachiza omhlaza kunye ne-penicillin, atsala ingqalelo engakumbi, kodwa amachiza aqhelekileyo awatsali ingqalelo kakhulu ekhaya nakwamanye amazwe.Eyona nto inzima kakhulu kukuba "ucoceko lwamashishini (IH)" lwexabiso lesithako esisebenzayo kunzima ukumisela kwaye kufuneka luqale kwi-toxicology kunye neklinikhi.Inqanaba lolawulo lwe-OEB lihlelwa ngokubanzi ngokweziphumo zemibuzo ye-MSDS yeekhompawundi.Ukuba wenza amachiza aqalayo, kungafuneka ukuba uchithe imali yakho kunye namandla ukwenza uvavanyo lwemisebenzi edibeneyo;Kumachiza enziwe afana nalawo aveliswe ngumenzi, imida kunye namabanga e-OEL/OEB angafunyanwa ngokubanzi ngokubuza ulwazi lwe-MSDS lwekhompawundi.Amanyathelo olawulo lobunjineli anxulumeneyo ahlulwe ngokubanzi: 1. Ukusebenza okuvulekileyo;2. Ukusebenza okuvaliweyo;3. Ubonelelo lomoya lulonke;4. Ukukhutshwa kwendawo;5. Ukuhamba kwelaminari;6. Oyedwa;7. I-valve ye-alpha beta, njl. Enyanisweni, sonke siyazi ezi zinto ngokwembono ye-GMP, kodwa isiqalo sokuqwalasela ngokuqhelekileyo sivela kumbono wokuthintela ukungcola kunye nokungcoliswa kwe-cross-contamination, kwaye kunqabile kwimbono yococeko lwamashishini.
Amashishini amayeza asekhaya kufuneka aqinise ukhuseleko lwabasebenzi be-EHS kwaye azise izixhobo zokuvelisa nge-API OEB yokulinganisa ibakala.Kufanelekile ukufumana izifundo kwinto yokuba abanye ababoneleli bezixhobo baseYurophu nabaseMelika benze kakuhle kakhulu ekukhuseleni abasebenzi babo, befuna iifayile ezihambelanayo zeMSDS kunye nokhuseleko oluhambelanayo kuthetha amaxwebhu okulungiselela iimveliso zovavanyo.Kwixesha elidlulileyo, xa amashishini amayeza asekhaya enza iimveliso ezahlukeneyo ezifana ne-anesthesia efanelekileyo kunye nokukhutshwa kwe-toxin, ukhuseleko lwe-OEB lwalungekho, olubangela ukuba impilo yabasebenzi abaninzi bangaphambili bachaphazeleke.Phantsi kwemeko yokuba ulwazi olusemthethweni lwabaqeshwa luye lwaqiniswa ngokuthe ngcembe, amashishini awakwazanga ukulubaleka uxanduva lweengozi ezihambelanayo zomsebenzi.
Ngokusebenzisa uhlalutyo lwengozi ye-API, i-formula yokubala ye-occupational exposure limit (OEL) inikezelwa, inkqubo yokuhlelwa kweengozi ze-API i-PBOEL iqaliswe, kwaye imigaqo eqhelekileyo ekufuneka ilandelwe kumanyathelo okuthintela nokulawula abekwe phambili.Kwixesha elizayo, siya kuhlalutya isicwangciso solawulo olunzulu.Hla umamele!
Ixesha lokuposa: Apr-12-2022