• ibhena_yephepha

Zingaphi iindawo ezinokuhlukaniswa kuzo igumbi lokuCoca le-GMP ngokubanzi?

Abanye abantu basenokuba baqhelene negumbi lokucoca le-GMP, kodwa uninzi lwabantu alukayiqondi. Abanye basenokungaqondi ngokupheleleyo nokuba bava into ethile, kwaye ngamanye amaxesha kunokubakho into nolwazi olungaziwayo ngabakhi abaziingcali. Kuba ulwahlulo lwegumbi lokucoca le-GMP kufuneka lwahlulwe ngokwesayensi ngokusekelwe kwezi nqanaba:

A: Ulawulo olufanelekileyo lwegumbi elicocekileyo; B: ukuhlangabezana neemfuno zenkqubo yemveliso;

C: Kulula ukuyilawula nokuyigcina; D: Icandelo leenkqubo zikarhulumente.

Igumbi elicocekileyo

Zingaphi iindawo ekufuneka igumbi elicocekileyo le-GMP lahlulwe ngazo?

1. Indawo yoMveliso kunye neGumbi eliNcedisayo elicocekileyo

Kubandakanya amagumbi acocekileyo abasebenzi, amagumbi acocekileyo ezinto zokwakha, kunye namanye amagumbi okuhlala, njl. Kukho ukhula, indawo yokugcina amanzi, kunye nenkunkuma yasezidolophini kwindawo yokuvelisa yegumbi elicocekileyo le-GMP. Indawo yokugcina igesi ye-ethylene oxide ibekwe ecaleni kwegumbi lokulala labasebenzi ngaphandle kweendlela zokukhusela, kwaye igumbi lesampulu libekwe ecaleni kwekhanteni yenkampani.

2. Isithili soLawulo kunye neSithili soLawulo

Kubandakanya iofisi, umsebenzi, ulawulo, kunye namagumbi okuphumla, njl. Iifektri kunye nezibonelelo zoshishino kufuneka zithobele imigaqo yokuvelisa, kwaye ulwakhiwo lwendawo yemveliso, amasebe olawulo, kunye neendawo ezincedisayo kufuneka lusebenze kwaye lungaphazamisani. Ukusekwa kwamasebe olawulo kunye neendawo zokuvelisa kuya kukhokelela ekuphazamisekeni okulinganayo kunye nolwakhiwo olungelulo olwenzululwazi.

3. Indawo yezixhobo kunye nendawo yokugcina izinto

Kubandakanya amagumbi okucoca iinkqubo zomoya opholileyo, amagumbi ombane, amagumbi amanzi acocekileyo aphezulu kunye negesi, amagumbi okupholisa kunye nezixhobo zokufudumeza, njl. Apha, kuyimfuneko ukuqwalasela kungekuphela nje indawo eyaneleyo yangaphakathi kwigumbi lokucoca le-gmp, kodwa kunye nemigaqo yobushushu kunye nokufuma kokusingqongileyo, kunye nezixhobo zokulungisa ubushushu kunye nokufuma kunye nezixhobo zokubeka esweni. Indawo yokugcina kunye nokuhambisa yegumbi lokucoca le-GMP kufuneka iqwalasele imigangatho yokugcina kunye nemigaqo yezinto ezikrwada, iimveliso zokupakisha, iimveliso eziphakathi, iimpahla, njl., kwaye yenze indawo yokugcina ngokweemeko ezifana nokulinda ukuhlolwa, ukuhlangabezana nemigangatho, ukungahlangabezani nemigangatho, ukubuyiselwa kunye nokutshintshiselana, okanye ukubuyiswa, okulungele ukuhlolwa rhoqo kweemonitha.

Ngokubanzi, ezi ziindawo ezimbalwa kwicandelo le-GMP clean room, kwaye ewe, kukwakho neendawo ezicocekileyo zokulawula amasuntswana othuli kubasebenzi. Uhlengahlengiso oluthile lunokufuneka lwenziwe ngokusekelwe kwimeko yokwenyani.

Igumbi lokucoca le-GMP

Ixesha lokuthumela: Meyi-21-2023