Kapangidwe kathunthu ka ukadaulo woyera ndi komwe nthawi zambiri timatcha chipinda choyera cha fakitale ya mankhwala, chomwe chimagawidwa m'magulu awiri: chipinda choyera cha mafakitale ndi chipinda choyera chachilengedwe. Ntchito yayikulu ya chipinda choyera cha mafakitale ndikuwongolera kuipitsa kwa tinthu tosakhala tachilengedwe, pomwe ntchito yayikulu ya chipinda choyera chachilengedwe ndikuwongolera kuipitsa kwa tinthu tachilengedwe. GMP ndiye muyezo wopanga mankhwala ndi kasamalidwe kabwino, komwe kumaonetsetsa kuti mankhwala ndi otetezeka komanso abwino. Pakupanga, kumanga ndi kugwiritsa ntchito zipinda zoyera mumakampani opanga mankhwala, miyezo yoyenera ya zipinda zoyera ndi zofunikira za kasamalidwe kabwino ka mankhwala ziyenera kutsatiridwa. Kenako, tikambirana za kapangidwe ka chipinda choyera cha fakitale yoyera ya mankhwala motsatira malamulo okongoletsa mkati mwa "Mafotokozedwe a Kapangidwe ka Fakitale Yoyera ya Makampani Opanga Mankhwala", kuphatikiza ndi zomwe Shanghai IVEN idakumana nazo pakupanga kwaukadaulo kwa mafakitale ophatikizika a mankhwala.

Kapangidwe ka Zipinda Zotsukira Zamakampani
Mu zipinda zoyera zamafakitale, zomera zopangira mankhwala ndi mapangidwe auinjiniya omwe nthawi zambiri timakumana nawo. Malinga ndi zofunikira za GMP pazipinda zoyera, pali zinthu zingapo zofunika zomwe ziyenera kuganiziridwa.

1. Ukhondo
Vuto la momwe mungasankhire molondola magawo mu workshop ya zinthu zopangidwa ndi manja. Malinga ndi zinthu zosiyanasiyana zaukadaulo, momwe mungasankhire molondola magawo a mapangidwe ndi vuto lalikulu pakupanga. Chizindikiro chofunikira chikuperekedwa mu GMP, ndiko kuti, mulingo wa kuyeretsa mpweya. Mulingo wa kuyeretsa mpweya ndiye chizindikiro chachikulu chowunikira kuyeretsa mpweya. Ngati mulingo wa kuyeretsa mpweya si wolondola, vuto la akavalo akuluakulu kukoka ngolo yaying'ono lidzawonekera, zomwe sizili zotsika mtengo komanso zopulumutsa mphamvu. Mwachitsanzo, mawonekedwe atsopano a phukusi la mulingo wa 300,000 omwe si oyenera kugwiritsidwa ntchito mu njira yayikulu yazinthu pakadali pano, koma omwe ndi othandiza kwambiri m'zipinda zina zothandizira.

Chifukwa chake, kusankha mulingo womwe umagwirizana mwachindunji ndi ubwino ndi chuma cha chinthucho. Magwero a fumbi omwe amakhudza ukhondo amachokera makamaka ku kupanga fumbi la zinthu panthawi yopanga, kuyenda kwa ogwiritsa ntchito komanso tinthu ta fumbi tomwe timabweretsedwa ndi mpweya wabwino wakunja. Kuphatikiza pa kugwiritsa ntchito zida zotsekedwa zochotsera utsi ndi fumbi pazida zopangira fumbi, njira yothandiza yowongolera kulowa kwa fumbi mchipindamo ndikugwiritsa ntchito kusefa kwa magawo atatu koyambirira, kwapakatikati komanso kogwira ntchito bwino kwambiri kwa mpweya watsopano wobwerera wa makina oziziritsira mpweya komanso chipinda chosambira kuti anthu adutse.

2. Mtengo wosinthira mpweya
Kawirikawiri, kuchuluka kwa kusintha kwa mpweya mu makina oziziritsira mpweya ndi nthawi 8 mpaka 10 pa ola limodzi, pomwe kuchuluka kochepa kwambiri kwa kusintha kwa mpweya mu chipinda choyera cha mafakitale ndi nthawi 12, ndipo kuchuluka kwakukulu ndi nthawi mazana ambiri. Mwachionekere, kusiyana kwa kusintha kwa mpweya kumabweretsa kusiyana kwakukulu kwa kuchuluka kwa mpweya ndi mphamvu zomwe zimagwiritsidwa ntchito. Pakapangidwe kake, potengera malo olondola aukhondo, ndikofunikira kuonetsetsa kuti mpweya umakhala wokwanira nthawi yopumira. Kupanda kutero, mavuto angapo angawonekere, monga zotsatira za ntchito sizili bwino, mphamvu yoletsa kusokoneza ya chipinda choyera ndi yotsika.

3. Kusiyana kwa kuthamanga kwa mpweya
Kusiyana kwa kuthamanga kwa mpweya pakati pa zipinda zoyera ndi zipinda zosayera pamlingo wosiyana sikuyenera kukhala kochepera 5pa, ndipo kuthamanga kwa mpweya pakati pa zipinda zoyera ndi zipinda zakunja sikuyenera kukhala kochepera 10Pa. Njira yowongolera kusiyana kwa kuthamanga kwa mpweya wosasunthika makamaka ndikupereka mpweya wabwino. Zipangizo zabwino zomwe zimagwiritsidwa ntchito popanga ndi valavu yotsalira ya kuthamanga, chowongolera mpweya wamagetsi wosiyana ndi mpweya wouma womwe umayikidwa pamalo otulutsira mpweya wobwerera. M'zaka zaposachedwa, nthawi zambiri pakupanga, mpweya woperekedwa ndi waukulu kuposa mpweya wobwerera komanso mpweya wotulutsa mpweya wotuluka mumlengalenga poyamba popanda chipangizo chabwino cha kuthamanga, ndipo makina owongolera okha amatha kuchita chimodzimodzi.

4. Kugawa mpweya
Njira yogawa mpweya mchipinda choyera ndiyo chinthu chofunikira kwambiri kuti chitsimikizire ukhondo. Njira yogawa mpweya yomwe imagwiritsidwa ntchito nthawi zambiri mu kapangidwe kameneka imatsimikiziridwa malinga ndi mulingo wa ukhondo. Mwachitsanzo, chipinda choyera cha magulu 300,000 nthawi zambiri chimagwiritsa ntchito njira yotumizira pamwamba ndi kumbuyo, zipinda zoyera za magulu 100,000 ndi 10,000 nthawi zambiri zimagwiritsa ntchito njira yoyendera mpweya yobwerera pamwamba ndi pansi, ndipo chipinda choyera chapamwamba chimagwiritsa ntchito njira yoyenda yolunjika kapena yoyimirira.

5. Kutentha ndi chinyezi
Kuwonjezera pa njira zapadera, poganizira za kutentha, mpweya wabwino ndi mpweya woziziritsa, cholinga chachikulu ndi kusunga bata la ogwira ntchito, ndiko kuti, kutentha ndi chinyezi choyenera. Kuphatikiza apo, pali zizindikiro zingapo zomwe ziyenera kutikopa chidwi, monga liwiro la mphepo ya m'mphepete mwa mpweya, phokoso, kuunikira ndi chiŵerengero cha kuchuluka kwa mpweya wabwino ndi zina zotero, zomwe sizinganyalanyazidwe pakupanga.

Kapangidwe ka chipinda choyera
Zipinda zoyera zachilengedwe zimagawidwa m'magulu awiri; zipinda zoyera zachilengedwe ndi zipinda zoyera zachilengedwe. Pa zipinda zoyera zamafakitale, popanga bwino kutentha, mpweya wabwino ndi mpweya wabwino, njira zofunika kwambiri zowongolera kuchuluka kwa ukhondo ndi kusefa ndi kupanikizika kwabwino. Pa zipinda zoyera zachilengedwe, kuwonjezera pa kugwiritsa ntchito njira zomwezo monga zipinda zoyera zamafakitale, ziyeneranso kuganiziridwa poganizira za chitetezo chachilengedwe, ndipo nthawi zina ndikofunikira kugwiritsa ntchito njira zoletsa kuipitsidwa kwa zinthuzo ku chilengedwe.
Kugwira ntchito kwa zinthu zoopsa kwambiri kumakhudzidwa ndi njira yopangira zinthu zomwe zikuchitika, ndipo makina ake oyeretsera mpweya ndi zinthu zina ziyeneranso kukwaniritsa zofunikira zapadera. Kusiyana pakati pa chipinda choyeretsera cha biosafety ndi chipinda choyeretsera mafakitale ndikuwonetsetsa kuti malo ogwirira ntchito akusunga mpweya woipa. Ngakhale kuti mulingo wa malo opangidwirawo suli wokwera kwambiri, udzakhala ndi chiopsezo chachikulu cha biohazard. Ponena za chiopsezo cha zamoyo, pali miyezo yofanana ku China, WTO ndi mayiko ena padziko lonse lapansi. Nthawi zambiri, njira zomwe zimagwiritsidwa ntchito ndi kudzipatula kwachiwiri. Choyamba, tizilombo toyambitsa matenda timachotsedwa kwa wogwiritsa ntchito ndi kabati yotetezera kapena bokosi lodzipatula, lomwe makamaka ndi chotchinga choletsa kusefukira kwa tizilombo toyambitsa matenda oopsa. Kudzipatula kwachiwiri kumatanthauza kudzipatula kwa labotale kapena malo ogwirira ntchito kuchokera kunja mwa kusandutsa malo opanikizika olakwika. Pa dongosolo loyeretsera mpweya, njira zina zimatengedwanso moyenerera, monga kusunga mpweya woipa wa 30Pa~10Pa mkati, ndikukhazikitsa malo oletsa mpweya woipa pakati pa malo oyandikana nawo osayera.

Shanghai IVEN nthawi zonse imakhala ndi udindo waukulu ndipo imatsatira miyezo yonse pamene ikuthandiza makasitomala kumanga mafakitale opanga mankhwala. Monga kampani yokhala ndi zaka zambiri zogwira ntchito yopereka uinjiniya wophatikizana wa mankhwala, IVEN ili ndi zaka zambiri zogwira ntchito mogwirizana padziko lonse lapansi. Pulojekiti iliyonse ya Shanghai IVEN ikugwirizana ndi miyezo ya EU GMP/US FDA GMP, WHO GMP, PIC/S GMP ndi mfundo zina. Kuwonjezera pa kupatsa makasitomala ntchito zapamwamba, IVEN imatsatiranso lingaliro la "kupereka thanzi kwa anthu".

Shanghai IVEN ikuyembekezera kugwira nanu ntchito.