Mankhwala a biopharmaceuticals amatanthauza mankhwala opangidwa pogwiritsa ntchito biotechnology, monga mankhwala opangidwa ndi zamoyo, zinthu zachilengedwe, mankhwala achilengedwe, ndi zina zotero. Popeza kuti kuyera, ntchito, ndi kukhazikika kwa mankhwalawo kuyenera kutsimikiziridwa popanga mankhwala a biopharmaceuticals, ukadaulo wa chipinda choyera uyenera kugwiritsidwa ntchito popanga kuti zitsimikizire kuti zinthu zili bwino komanso zotetezeka. Kapangidwe, kapangidwe, ndi kagwiritsidwe ntchito ka chipinda choyera cha biopharmaceutical GMP kumafuna kutsatira kwambiri zomwe GMP imafuna, kuphatikizapo kuwongolera kuyera kwa mpweya, kutentha, chinyezi, kusiyana kwa kuthamanga ndi zina, komanso kuyang'anira antchito, zida, zipangizo, ndi zinyalala m'chipinda choyera. Nthawi yomweyo, ukadaulo wapamwamba wa chipinda choyera ndi zida, monga hepa filter, air shawa, benchi yoyera, ndi zina zotero, zimafunikanso kuti zitsimikizire kuti mpweya wabwino ndi kuchuluka kwa tizilombo toyambitsa matenda m'chipinda choyera zikukwaniritsa zofunikira.
Kapangidwe ka chipinda choyera cha mankhwala cha gmp
1. Kapangidwe ka zipinda zoyera sikungakwaniritse zosowa zenizeni za kupanga. Pa ntchito zatsopano zoyera zipinda kapena ntchito zazikulu zoyeretsa zipinda, eni nyumba nthawi zambiri amalemba ntchito mabungwe okonza mapulani kuti apange mapangidwe. Pa ntchito zazing'ono ndi zapakatikati zoyeretsa zipinda, poganizira mtengo wake, mwiniwake nthawi zambiri amasaina pangano ndi kampani ya uinjiniya, ndipo kampani ya uinjiniya idzakhala ndi udindo pa ntchito yokonza mapulani.
2. Pofuna kusokoneza cholinga cha kuyesa chipinda choyera, kuyesa magwiridwe antchito a chipinda choyera ndi ntchito yowunikira ndi gawo lofunikira kwambiri kuti muyese ngati zofunikira pakupanga zakwaniritsidwa (kuyesa kuvomereza) ndikuwonetsetsa kuti chipinda choyera chili bwino (kuyesa nthawi zonse) pamene kumanga chipinda choyera kwatha. Kuyesa kuvomereza kumaphatikizapo magawo awiri: kuyitanitsa kumaliza ndi kuwunika kwathunthu momwe chipinda choyera chikuyendera.
3. Mavuto pa ntchito yoyeretsa chipinda
①Mpweya suli bwino
②Kugwira ntchito mosakhazikika kwa antchito
③Kukonza zida sikunachitike pa nthawi yake
④ Kuyeretsa kosakwanira
⑤Kutaya zinyalala kosayenera
⑥Chikoka cha zinthu zachilengedwe
Pali zinthu zingapo zofunika kuziganizira popanga chipinda chotsukira mankhwala cha GMP.
1. Ukhondo wa mpweya
Vuto la momwe mungasankhire molondola magawo mu workshop ya zinthu zaluso. Malinga ndi zinthu zosiyanasiyana zaluso, momwe mungasankhire molondola magawo a mapangidwe ndi nkhani yayikulu pakupanga. GMP ikupereka zizindikiro zofunika, kutanthauza kuchuluka kwa kuyeretsa mpweya. Tebulo lotsatirali likuwonetsa kuchuluka kwa kuyeretsa mpweya komwe kwatchulidwa mu GMP ya dziko langa ya 1998: Nthawi yomweyo, WHO (World Health Organization) ndi EU (European Union) onse ali ndi zofunikira zosiyana pa kuchuluka kwa ukhondo. . Magawo omwe ali pamwambapa awonetsa bwino kuchuluka, kukula, ndi momwe tinthu tating'onoting'ono timakhalira.
Zikuoneka kuti ukhondo wa fumbi lochuluka ndi wochepa, ndipo ukhondo wa fumbi lochepa ndi wokwera. Ukhondo wa mpweya ndiye chizindikiro chachikulu chowunikira malo oyera. Mwachitsanzo, muyezo wa 300,000 umachokera ku mfundo yatsopano yopangira yomwe yaperekedwa ndi Medical Bureau. Pakadali pano sikoyenera kugwiritsidwa ntchito popangira zinthu zazikulu, koma imagwira ntchito bwino ikagwiritsidwa ntchito m'zipinda zina zothandizira.
2. Kusinthana kwa mpweya
Chiwerengero cha kusintha kwa mpweya mu makina oziziritsira mpweya ndi nthawi 8 mpaka 10 pa ola limodzi, pomwe chiwerengero cha kusintha kwa mpweya mu chipinda choyera cha mafakitale ndi nthawi 12 pamlingo wotsika kwambiri komanso nthawi mazana angapo pamlingo wapamwamba kwambiri. Mwachionekere, kusiyana kwa kusintha kwa mpweya kumayambitsa kuchuluka kwa mpweya Kusiyana kwakukulu pakugwiritsa ntchito mphamvu. Pakapangidwe kake, potengera malo olondola aukhondo, nthawi yokwanira yosinthira mpweya iyenera kutsimikizika. Kupanda kutero, zotsatira za ntchito sizidzakhala zokhazikika, mphamvu yoletsa kusokoneza chipinda choyera idzakhala yofooka, mphamvu yodziyeretsa yokha idzakulitsidwa, ndipo mavuto angapo adzaposa phindu.
3. Kusiyana kwa kuthamanga kwa mpweya
Pali zofunikira zingapo monga mtunda pakati pa zipinda zoyera za milingo yosiyanasiyana ndi zipinda zosayera sizingakhale zochepera 5Pa, ndipo mtunda pakati pa zipinda zoyera ndi zakunja sungakhale wochepera 10Pa. Njira yowongolera kusiyana kwa kuthamanga kwa mpweya wosasunthika makamaka ndikupereka mpweya wabwino. Zipangizo zabwino zomwe zimagwiritsidwa ntchito popanga ndi ma valve otsalira, zowongolera mpweya wamagetsi wosiyana ndi mpweya wozizira komanso zigawo zopopera mpweya zomwe zimayikidwa pamalo opumulira mpweya wobwerera. M'zaka zaposachedwa, njira yosakhazikitsa chipangizo chabwino chopondereza koma kupangitsa mpweya wotuluka kukhala waukulu kuposa mpweya wobwerera komanso mpweya wotulutsa mpweya panthawi yoyambitsa ntchito nthawi zambiri imagwiritsidwa ntchito popanga, ndipo makina owongolera okhazikika amathanso kukwaniritsa zotsatira zomwezo.
4. Kapangidwe ka kayendedwe ka mpweya
Kapangidwe ka kayendedwe ka mpweya m'chipinda choyera ndi chinthu chofunikira kwambiri pakutsimikizira mulingo wa ukhondo. Kapangidwe ka kayendedwe ka mpweya komwe kamagwiritsidwa ntchito nthawi zambiri kamatsimikiziridwa kutengera mulingo wa ukhondo. Mwachitsanzo, kapangidwe ka chipinda choyera cha kalasi 300,000 nthawi zambiri kamagwiritsa ntchito mpweya wotuluka pamwamba ndi wotuluka pamwamba, kapangidwe ka chipinda choyera cha kalasi 100000 ndi kalasi 10000 nthawi zambiri kamagwiritsa ntchito mpweya wotuluka pamwamba ndi wotuluka pansi, ndipo zipinda zoyera zapamwamba zimagwiritsa ntchito kayendedwe kolunjika kapena kolunjika.
5. Kutentha ndi chinyezi
Kuwonjezera pa ukadaulo wapadera, poganizira za kutentha, mpweya wabwino ndi mpweya woziziritsa, imasunga chitonthozo cha wogwiritsa ntchito, kutanthauza kutentha ndi chinyezi choyenera. Kuphatikiza apo, pali zizindikiro zingapo zomwe ziyenera kukopa chidwi chathu, monga liwiro la mphepo yodutsa m'mbali mwa duct ya tuyere, phokoso, liwiro la mphepo yodutsa m'mbali mwa duct ya tuyere, phokoso, kuunikira, ndi chiŵerengero cha kuchuluka kwa mpweya wabwino, ndi zina zotero. Mbali izi sizinganyalanyazidwe pakupanga.
Kapangidwe ka chipinda choyera cha biopharmaceutical
Zipinda zoyera zamoyo zimagawidwa m'magulu awiri; zipinda zoyera zamoyo ndi zipinda zoyera zachitetezo chamoyo. Opanga mainjiniya a HVAC nthawi zambiri amakumana ndi zoyera, zomwe zimawongolera kuipitsa kwa ogwiritsa ntchito ndi tinthu tamoyo. Pamlingo wina, ndi chipinda choyera cha mafakitale chomwe chimawonjezera njira zoyeretsera. Pazipinda zoyera zamakampani, popanga makina aukadaulo a HVAC, njira yofunika kwambiri yowongolera kuchuluka kwa ukhondo ndi kusefa ndi kupanikizika kwabwino. Pazipinda zoyera zamoyo, kuwonjezera pa kugwiritsa ntchito njira zomwezo monga zipinda zoyera zamakampani, ndikofunikiranso kuganizira za chitetezo chachilengedwe. Nthawi zina ndikofunikira kugwiritsa ntchito kupanikizika koyipa kuti zinthu zisaipitse chilengedwe.
Nthawi yotumizira: Disembala-25-2023