1. Izinjongo zokuqeqesha
Ngokuqeqeshwa, ukuthuthukisa ithiyori yokuvala inzalo kanye nezinga lokusebenza okungokoqobo kwabaqeqeshwayo, ukuxazulula izinkinga ezinzima okuhlangatshezwane nazo ohlelweni lokusetshenziswa kwemishini nokugcinwa kwemishini, ukukhuthaza ukusebenza okujwayelekile, kanye nokwenza ngcono isayensi nokuphepha kokuvala inzalo eshisayo ekudleni.
Lokhu kuqeqeshwa kulwela ukusiza abaqeqeshwayo ukuthi bafunde ngokugcwele ulwazi oluyisisekelo lwethiyori lokuvala inzalo eshisayo, baqonde izimiso, izindlela nezinyathelo zokwenza izinqubo zokuvala inzalo, futhi bajwayelane futhi bathuthukise izinqubo zokusebenza ezinhle ekusebenziseni inzalo yokudla okushisayo, futhi bathuthukise amathuba okuba khona. zokuhlangana emsebenzini wokuvala inzalo eshisayo.Ikhono lokubhekana nezinkinga lifinyelelwe.
2. Okuqukethwe kokuqeqeshwa okuyinhloko
(1) Isimiso esiyisisekelo sokuvala inzalo okushisayo kokudla okusemathinini
1. Izimiso zokulondoloza ukudla
2. I-Microbiology Yokudla Okusemathinini
3. Imiqondo eyisisekelo yokuvala inzalo eshisayo (inani lika-D, inani lika-Z, inani lika-F, ukuphepha kuka-F, i-LR neminye imiqondo kanye nokusetshenziswa okungokoqobo)
4. Incazelo yezinyathelo zendlela kanye nezibonelo zokwenza imithetho yokuvala inzalo ekudleni
(2) Amazinga kanye nokusetshenziswa okungokoqobo kokuvala inzalo eshisayo ekudleni
1. Izidingo zokulawula ze-US FDA zemishini yokuvala inzalo eshisayo kanye nokucushwa
2. Izinqubo ezijwayelekile zokuvala inzalo zichazwa ngesinyathelo ngesinyathelo-exhaust, izinga lokushisa elingashintshi, ukupholisa, indlela yokungena kwamanzi, ukulawula ingcindezi, njll.
3. Izinkinga ezivamile kanye nokuchezuka emisebenzini yokuvala inzalo eshisayo
4. Amarekhodi ahlobene nokuvala inzalo
5. Izinkinga ezivamile ekwakhiweni kwamanje kwezinqubo zokuvala inzalo
(3) Ukusabalalisa ukushisa kwe-retor, isimiso sokuhlola ukungena kokushisa kokudla kanye nokuhlolwa kwemiphumela
1. Inhloso yokuhlolwa kwe-thermodynamic
2. Izindlela zokuhlola i-thermodynamic
3. Incazelo enemininingwane yezizathu ezithinta imiphumela yokuhlolwa kokusabalalisa ukushisa kwesibulala-magciwane
4. Ukusetshenziswa kokuhlolwa kokungena okushisayo ekwenzeni izinqubo zokuvala inzalo yomkhiqizo
(4) Amaphuzu okulawula abalulekile ekwelashweni kwangaphambi kokwenziwa inzalo
1. Izinga lokushisa (izinga lokushisa lesikhungo somkhiqizo, izinga lokushisa lokupakisha, izinga lokushisa lokugcina, izinga lokushisa lomkhiqizo ngaphambi kokuvalwa inzalo)
2. Isikhathi (isikhathi sokwenza imali esiluhlaza nesiphekiwe, isikhathi sokupholisa, isikhathi sokugcina ngaphambi kokuvala inzalo)
3. Ukulawulwa kwamagciwane (izinto zokusetshenziswa, ukuvuthwa, ukungcoliswa kwamathuluzi namathuluzi okwenza inzuzo, kanye nenani lebhaktheriya ngaphambi kokuvalwa inzalo)
(5) Ukugcinwa nokugcinwa kwemishini yokuvala inzalo
(6) Ukuxazulula inkinga okuvamile kanye nokuvimbela okokusebenza kokuvala inzalo
3. Isikhathi sokuqeqesha
Meyi 13, 2020
Isikhathi sokuthumela: Aug-08-2020