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Izinga Lemininingwane E-USA, imigomo ye-GMP ifakwe engxenyeni 210 kanye nengxenye 211 yekhodi yemithetho yenhlangano.Ngenxa yokuthi le mithetho kunzima ukuyichibiyela noma ukungeza, i-FDA ikhiphe imibhalo ehlukene yemithetho ye-GMP kanye neziqondiso zokusebenza kwezemithi, njenge-Guidance for...Funda kabanzi»
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I-GMP (Good Manufacturing Practice) iwumhlahlandlela okuhloswe ngawo ukulawula nokwengamela imisebenzi yokukhiqiza imithi emhlabeni wonke.Kuyimvume edingekayo futhi kubakhiqizi bemithi ukuthi bangene emkhakheni wohwebo lwamazwe ngamazwe.I-GMP ifaka: indawo, abantu, indawo, inhlanzeko, ukuqinisekiswa, ukwenza ...Funda kabanzi»
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I-China ibilokhu iyimakethe enkulu esafufusa yemboni yezemithi, muva nje ikhombisa ukuthi kungenzeka ukubusa emhlabeni.Phakathi kwazo, imishini yokwenza imithi ilokhu ikhula futhi ilandela eduze abakhiqizi bemithi.Kulokhu, yini ezokwenzeka esikhathini esizayo?1. Okuzenzakalelayo...Funda kabanzi»
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1. Khetha ama-excipients afanele Ngemva kokwengeza i-hydrated magnesium silicate kuma-herbal medicine granules, i-angle yokuphumula yehle ngokusobala, uketshezi lunyukile futhi ukuhluka kokugcwalisa kwesisindo kuye kwancipha.Ngakolunye uhlangothi, i-Avicel PH302 njenge-diluent iphinde inciphise ukuhluka kwesisindo sokugcwalisa...Funda kabanzi»
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Izimbangela ezintathu ezingenzeka zidinga ukutholakala: igobolondo le-capsule, izici zokuqukethwe kanye nemishini.Igobolondo le-Capsule Kubalulekile ukuqinisekisa ikhwalithi ye-capsule yakho engenalutho.Noma yiliphi igobolondo le-capsule elintekenteke noma elikhubazekile lingaletha imiphumela eyinhlekelele.Hlola igobolondo le-capsule ngamakhemikhali nangokomzimba...Funda kabanzi»
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I-Vacuum Decapsulator empeleni iwuhlobo olungajwayelekile kangako emakethe yezemithi, ikakhulukazi ngoba i-encapsulation kulula ukuyilawula.Noma kunjalo, lo mshini ongajwayelekile usathandwa phakathi kwabakhiqizi bemithi njengesixwayiso esidingekayo sokuvalwa kwe-capsule okungafanele.Nazi ezinye izinzuzo zoku...Funda kabanzi»
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Kungani ukhethe i-Halo Pharmatech njengomunye wabahlinzeki bakho embonini yezemithi?Nazi ezinye izizathu zokuthi uthole: Ukuqanjwa Kwemikhiqizo Emisha kanye nokwenza ngcono kuyitshe legumbi lokuthuthukiswa komkhiqizo.E-Halo Pharmatech, yonke imishini iklanyelwe ngokusekelwe esidingweni somkhiqizo wemithi...Funda kabanzi»
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Enqubweni yokuvalwa kwe-capsule yezemithi, ukukhubazeka kwe-capsule egcwele kubonakala kuyinkinga enzima kakhulu.Ukuhlukana, amaphilisi e-telescoped, ukugoqa kanye nama-cap tucks kwenzeka ngesikhathi sokuvalwa kwe-capsule, okubangela amathuba okuvuza komkhiqizo.Uma ama-capsules anesici cishe engenakugwemeka, ukulahlwa noma...Funda kabanzi»
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Amaphilisi angenalutho enziwe nge-gelatin, etholakala kumaprotheni esilwane (isikhumba sengulube, amathambo ezilwane & esikhumba namathambo ezinhlanzi) kanye nama-polysaccharides ezitshalo noma okuphuma kuwo (i-HPMC, isitashi, i-pupulan nokunye).Lawa ma-capsules angenalutho enziwa ngama-halves amabili: "umzimba" wobubanzi obuphansi ...Funda kabanzi»
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Emuva ngo-2012, i-Halo Pharmatech yaqala ukwakha i-capsule checkweigher yohlobo olusha, eyayihlukaniswa neningi leminye imishini yokukala emakethe.Ngokungafani nezinye izinhlobo ze-capsule weigher, isivinini sokusebenza salo mshini asilungisiwe, sifika ngokuphelele kumsebenzisi wawo.Isakhiwo esithandwa yibhlokhi...Funda kabanzi»