Izinyathelo zokulawula ikhwalithi zezimboni zemithi ze-HPMC (hydroxypropyl methylcellulose) ziyindlela ebalulekile yokuqinisekisa ukuvumelana, ukuhlanzeka nokuphepha kwemikhiqizo phakathi nenqubo yokukhiqiza.
1. Ukulawula impahla eluhlaza
1.1 Ukuhlolwa komphakeli wezinto ezingavuthiwe
Izimboni ezenza imithi zidinga ukukhetha abahlinzeki bempahla eluhlaza abaqinisekisiwe futhi zibahlole futhi zibahlole njalo ukuze kuqinisekiswe ukuzinza kwekhwalithi yezinto ezingavuthiwe.
1.2 Ukwamukelwa kokuhlolwa kwezinto ezingavuthiwe
Iqoqo ngalinye lezinto ezingavuthiwe kufanele zihlolwe ngokuqinile ngaphambi kokungena ohlelweni lokukhiqiza, njengokuhlolwa kokubukeka, ukuhlaziya ukwakheka kwamakhemikhali, ukunqunywa kokuqukethwe komswakama, njll., ukuze kuqinisekiswe ukuthi ziyahlangabezana nezindinganiso zekhwalithi.
1.3 Ukuqapha isimo sesitoreji
Indawo yokugcina izinto ezingavuthiwe ilawulwa ngokuqinile, njengezinga lokushisa nomswakama, ukuvimbela izinguquko zekhwalithi ngesikhathi sokugcina.
2. Ukulawulwa kwenqubo yokukhiqiza
2.1 Ukuqinisekiswa kwenqubo
Inqubo yokukhiqiza kufanele iqinisekiswe ukuze kuqinisekiswe ukuthi ingakhiqiza ngokuzinza imikhiqizo ehlangabezana namazinga ekhwalithi alindelekile.Ukuqinisekisa kufaka phakathi ukusetha amapharamitha enqubo, ukuhlonza nokuqapha izindawo zokulawula ezibucayi (CCP) ohlelweni lokukhiqiza.
2.2 Ukuqapha ku-inthanethi
Phakathi nenqubo yokukhiqiza, imishini yokuqapha ethuthukisiwe ye-inthanethi isetshenziselwa ukuqapha imingcele ebalulekile ngesikhathi sangempela, njengokushisa, ukucindezela, isivinini esishukumisayo, njll, ukuqinisekisa ukuthi inqubo yokukhiqiza isebenza ngaphakathi kwebanga elimisiwe.
2.3 Ukuhlolwa Komkhiqizo Okumaphakathi
Imikhiqizo ephakathi iyathathwa futhi ihlolwe njalo ukuze kuqinisekiswe ukuthi izinga layo lihlala lingashintshile kuzo zonke izigaba zokukhiqiza.Lokhu kuhlola kufaka phakathi izakhiwo ezingokomzimba namakhemikhali njengokubukeka, ukuncibilika, i-viscosity, inani le-pH, njll.
3. Ukulawulwa Kwekhwalithi Yomkhiqizo Kuqediwe
3.1 Ukuhlolwa Komkhiqizo Okuphelile
Umkhiqizo wokugcina ungaphansi kokuhlolwa kwekhwalithi okuphelele, okuhlanganisa ukubukeka, izakhiwo zomzimba namakhemikhali, ubumsulwa, okuqukethwe ukungcola, njll., ukuze kuqinisekiswe ukuthi umkhiqizo uhlangabezana ne-pharmacopoeia noma izindinganiso zangaphakathi.
3.2 Ukuhlola Ukuzinza
Umkhiqizo oqediwe uhlolelwa ukuzinza ukuze kuhlolwe izinguquko zekhwalithi yomkhiqizo ngesikhathi sokugcinwa.Izinto zokuhlola zihlanganisa ukubukeka, ukufana kokuqukethwe, ukwenziwa kokungcola, njll.
3.3 Ukuhlolwa Kokukhishwa
Ngemuva kokuthi ukuhlolwa komkhiqizo oqediwe sekufanelekile, kuyadingeka futhi ukuthi kuhlolwe ukukhishwa ukuze kuqinisekiswe ukuthi umkhiqizo uhlangabezana nazo zonke izidingo zekhwalithi ngaphambi kokuthengisa noma ukusetshenziswa.
4. Izisetshenziswa kanye nokulawulwa kwemvelo
4.1 Ukuqinisekiswa Kokuhlanza Izinsiza
Izinto ezisetshenziswayo zokukhiqiza zidinga ukuhlanzwa futhi zibulawe amagciwane njalo, futhi umphumela wokuhlanza kufanele uqinisekiswe ukuze kuvinjelwe ukungcola okuphambanayo.Ukuqinisekisa kufaka phakathi ukutholwa kwezinsalela, ukusetha ipharamitha yokuhlanza kanye namarekhodi enqubo yokuhlanza.
4.2 Ukuqapha Imvelo
Izimo zemvelo endaweni yokukhiqiza zigadwa ngokuqinile, okuhlanganisa ukuhlanzeka komoya, umthwalo we-microbial, izinga lokushisa kanye nomswakama, ukuze kuqinisekiswe ukuthi indawo yokukhiqiza ihlangabezana nezidingo ze-GMP (Good Manufacturing Practice).
4.3 Ukugcinwa Kwezisetshenziswa kanye Nokulinganisa
Izinto zokwakha zidinga ukunakekelwa futhi zilinganiswe njalo ukuze kuqinisekiswe ukusebenza kwazo okuvamile kanye nokunemba kwesilinganiso, nokugwema ukwehluleka kwezisetshenziswa ezithinta ikhwalithi yomkhiqizo.
5. Ukuqeqeshwa Nokuphathwa Kwabasebenzi
5.1 Ukuqeqeshwa Kwabasebenzi
Abasebenzi abakhiqizayo nabalawula ikhwalithi badinga ukuthola ukuqeqeshwa njalo ukuze bakwazi izinqubo zakamuva zokusebenza, izindlela zokulawula ikhwalithi kanye nezidingo ze-GMP ukuze bathuthukise amakhono abo ochwepheshe kanye nokuqwashisa ngekhwalithi.
5.2 Uhlelo Lokubophezela Umsebenzi
Uhlelo lwesibopho somsebenzi luyasetshenziswa, futhi isixhumanisi ngasinye sinomuntu ozinikele ophethe, ocacisa izibopho zabo ekulawuleni ikhwalithi nokuqinisekisa ukuthi izinyathelo zokulawula ikhwalithi zingasetshenziswa ngokuphumelelayo kusixhumanisi ngasinye.
5.3 Ukuhlolwa kokusebenza
Ngasikhathi sinye hlaziya umsebenzi wabasebenzi abalawula ikhwalithi ukuze ubakhuthaze ukuthi bathuthukise izinga lomsebenzi nokusebenza kahle, futhi ukhombe ngokushesha futhi ulungise izinkinga ekusebenzeni.
6. Ukuphathwa kwemibhalo
6.1 Amarekhodi nemibiko
Yonke idatha nemiphumela yenqubo yokulawula ikhwalithi kufanele irekhodwe futhi umbiko ophelele kufanele wakhelwe ukuze ubuyekezwe futhi ulandeleke.Lawa marekhodi ahlanganisa ukwamukelwa kwezinto ezingavuthiwe, imingcele yenqubo yokukhiqiza, imiphumela yokuhlolwa komkhiqizo ophelile, njll.
6.2 Ukubuyekezwa kombhalo
Hlaziya futhi ubuyekeze amadokhumenti ahlobene nokulawulwa kwekhwalithi ukuze uqinisekise ukunemba nokufika ngesikhathi kokuqukethwe kwawo futhi ugweme izinkinga zekhwalithi ezibangelwa amadokhumenti aphelelwe yisikhathi noma angalungile.
7. Ukuhlolwa kwangaphakathi nokuhlolwa kwangaphandle
7.1 Ukucwaninga kwangaphakathi
Izimboni ezenza imithi kudingeka zenze ucwaningo lwangaphakathi njalo ukuze zihlole ukuqaliswa kokulawulwa kwekhwalithi kusixhumanisi ngasinye, zibone futhi zilungise ubungozi bekhwalithi obungaba khona, futhi zithuthukise ngokuqhubekayo uhlelo lokuphatha ikhwalithi.
7.2 Ukuhlolwa kwangaphandle
Yamukela ukuhlolwa okuvamile kweziphathimandla ezilawulayo zikahulumeni nama-ejensi ezinkampani zangaphandle ezinikeza izitifiketi ukuze uqinisekise ukuthi uhlelo lokulawula ikhwalithi luhambisana nemithetho efanele, izimiso kanye namazinga emboni.
8. Ukuphathwa kwesikhalazo nokukhumbula
8.1 Ukusingatha izikhalo
Izimboni ezenza imithi kufanele zisungule indlela ekhethekile yokusingatha izikhalazo ukuze ziqoqe futhi zihlaziye impendulo yamakhasimende ngesikhathi, zixazulule izinkinga zekhwalithi, futhi zithathe izinyathelo zokuthuthukisa ezihambisanayo.
8.2 Ukukhumbula umkhiqizo
Yakha futhi usebenzise izinqubo zokukhumbula umkhiqizo, futhi lapho izinkinga zekhwalithi engathi sína noma izingozi zokuphepha zitholakala emikhiqizweni, bangakhumbula ngokushesha imikhiqizo eyinkinga futhi bathathe izinyathelo zokulungisa ezihambisanayo.
9. Ukuthuthuka okuqhubekayo
9.1 Ukulawulwa kwekhwalithi yobungozi
Sebenzisa amathuluzi okulawula ubungozi bekhwalithi (njenge-FMEA, i-HACCP) ukuze uhlole futhi ulawule ubungozi, uhlonze futhi ulawule ubungozi bekhwalithi obungaba khona.
9.2 Uhlelo lokuthuthukisa ikhwalithi
Dala uhlelo lokuthuthukisa ikhwalithi ukuze uthuthukise ngokuqhubekayo izinqubo zokukhiqiza futhi uthuthukise ikhwalithi yomkhiqizo ngokusekelwe kudatha yokulawula ikhwalithi nemiphumela yocwaningo.
9.3 Ukuthuthukiswa kobuchwepheshe
Yethula ubuchwepheshe obusha namathuluzi, ngokuqhubekayo ubuyekeze futhi uthuthukise izindlela zokukhiqiza nezindlela zokulawula ikhwalithi, futhi uthuthukise ukunemba kokutholwa nokusebenza kahle kokukhiqiza.
Lezi zinyathelo zokulawula ikhwalithi ziqinisekisa ukuthi izimboni zemithi ze-HPMC zingaqhubeka zikhiqiza imikhiqizo yekhwalithi ephezulu, ethobelana nemithetho phakathi nenqubo yokukhiqiza, ngaleyo ndlela iqinisekise ukuphepha nokusebenza kwezidakamizwa.
Isikhathi sokuthumela: Jul-03-2024