Chiyambireni kulengeza kwake mu 1992, "Good Manufacturing Practice for Drugs" (GMP) mumakampani opanga mankhwala ku China pang'onopang'ono azindikirika, kuvomerezedwa, ndikukhazikitsidwa ndi mabizinesi opanga mankhwala.GMP ndi mfundo yovomerezeka yadziko lonse yamabizinesi, ndipo mabizinesi omwe amalephera kukwaniritsa zofunikira mkati mwanthawi yomwe yatchulidwa adzasiya kupanga.
Zomwe zili pachiphaso cha GMP ndikuwongolera kasamalidwe kabwino kakupanga mankhwala.Zomwe zili mkati mwake zitha kufotokozedwa mwachidule m'magawo awiri: kasamalidwe ka mapulogalamu ndi zida za Hardware.Nyumba yosungiramo zipinda zoyera ndi imodzi mwazinthu zazikulu zopangira ndalama muzinthu zamagetsi.Mukamaliza kumanga chipinda choyera, ngati chitha kukwaniritsa zolinga zake ndikukwaniritsa zofunikira za GMP ziyenera kutsimikiziridwa poyesa.
Mkati mwa kuyendera zipinda zaukhondo, ena a iwo analephera kuyendera ukhondo, ena anali am'deralo ku fakitale, ndipo ena anali ntchito yonse.Ngati kuyenderako sikuli koyenerera, ngakhale kuti mbali zonse ziwiri zakwaniritsa zofunikira kudzera mu kukonzanso, kukonza zolakwika, kuyeretsa, ndi zina zotero, nthawi zambiri zimawononga anthu ambiri ndi zinthu zakuthupi, zimachedwetsa nthawi yomanga, ndikuchedwetsa ndondomeko ya chiphaso cha GMP.Zifukwa zina ndi zolakwika zitha kupewedwa musanayesedwe.Pantchito yathu yeniyeni, tapeza kuti zifukwa zazikulu ndi njira zowongolera zaukhondo wosayenerera ndi kulephera kwa GMP ndi:
1. Mapangidwe a uinjiniya osayenerera
Chodabwitsa ichi ndi chosowa, makamaka pomanga zipinda zazing'ono zoyera ndi zofunikira zaukhondo.Mpikisano wa uinjiniya wa zipinda zoyera ndiwowopsa tsopano, ndipo mayunitsi ena omanga apereka mawu ochepera pamabizinesi awo kuti apeze ntchitoyi.M'magawo omangamanga, mayunitsi ena adagwiritsidwa ntchito kudula ngodya ndikugwiritsa ntchito mayunitsi ochepetsera mpweya komanso mpweya wabwino wa kompresa chifukwa chosowa chidziwitso, zomwe zidapangitsa kuti magetsi azikhala osagwirizana komanso malo oyera, zomwe zimapangitsa kuti pakhale ukhondo wosayenerera.Chifukwa china ndi chakuti wogwiritsa ntchitoyo adawonjezera zofunikira zatsopano ndi malo oyera pambuyo poyambira kupanga ndi kumanga, zomwe zidzapangitsenso kuti mapangidwe oyambirira asakwaniritsidwe.Chilema chobadwa nachochi ndi chovuta kuwongolera ndipo chikuyenera kupewedwa panthawi yopanga uinjiniya.
2. Kusintha zinthu zapamwamba ndi zotsika mtengo
Pogwiritsira ntchito zosefera za hepa m’zipinda zoyera, dzikolo likunena kuti pamankhwala oyeretsa mpweya ndi mlingo waukhondo wa 100000 kapena kupitirira apo, kusefa kwa magawo atatu a zosefera za pulayimale, zapakati, ndi za hepa ziyenera kugwiritsidwa ntchito.Panthawi yotsimikizira, zidapezeka kuti projekiti yayikulu yachipinda choyera idagwiritsa ntchito fyuluta ya mpweya ya sub hepa kuti ilowe m'malo mwa fyuluta ya mpweya wa hepa pamlingo waukhondo wa 10000, zomwe zimapangitsa kuti pakhale ukhondo wosayenerera.Pomaliza, fyuluta yochita bwino kwambiri idasinthidwa kuti ikwaniritse zofunikira za certification ya GMP.
3. Kusasindikizidwa bwino kwa njira yoperekera mpweya kapena fyuluta
Chodabwitsa ichi chimayamba chifukwa cha zomangamanga zovuta, ndipo panthawi yovomerezeka, zingawoneke kuti chipinda china kapena gawo limodzi la dongosolo lomwelo silili oyenerera.Njira yosinthira ndikugwiritsa ntchito njira yoyesera yotayira panjira yoperekera mpweya, ndipo fyulutayo imagwiritsa ntchito kauntala ya tinthu ting'onoting'ono kuti ijambule gawo lalikulu, guluu wosindikiza, ndi chimango choyikira chosefera, kuzindikira komwe kudatsikira, ndikusindikiza mosamala.
4. Kusakonza bwino ndi kutumiza kwa ma ducts obwerera mpweya kapena ma air vents
Pazifukwa zamapangidwe, nthawi zina chifukwa cha kuchepa kwa malo, kugwiritsa ntchito "kubwereranso kwapamwamba" kapena kuchuluka kwa mpweya wobwerera sikutheka.Pambuyo pochotsa zifukwa zamapangidwe, kukonzanso kwa mpweya wobwereranso ndi njira yofunikira yomanga.Ngati kusokoneza sikuli bwino, kukana kwa mpweya wobwerera kumakhala kwakukulu kwambiri, ndipo voliyumu yobwereranso imakhala yochepa kusiyana ndi kuchuluka kwa mpweya woperekera, kumayambitsanso ukhondo wosayenerera.Kuonjezera apo, kutalika kwa mpweya wobwerera kuchokera pansi panthawi yomanga kumakhudzanso ukhondo.
5. Kusakwanira nthawi yodziyeretsa pazipinda zoyera panthawi yoyezetsa
Malinga ndi muyezo wadziko lonse, kuyesako kuyambika pakatha mphindi 30 makina oyeretsera mpweya akugwira ntchito bwino.Ngati nthawi yothamanga ndi yochepa kwambiri, ingayambitsenso ukhondo wosayenerera.Pankhaniyi, ndikwanira kukulitsa nthawi yogwiritsira ntchito makina oyeretsera mpweya moyenera.
6. Njira yoyeretsera mpweya yoyeretsera sinayeretsedwe bwino
Panthawi yomanga, njira yonse yoyeretsera mpweya, makamaka zoperekera ndi kubwezeretsa mpweya, sizimalizidwa nthawi imodzi, ndipo ogwira ntchito yomangamanga ndi malo omanga angayambitse kuipitsidwa kwa ma ducts ndi zosefera.Ngati sichiyeretsedwa bwino, chidzakhudza zotsatira za mayeso.Njira yosinthira ndikuyeretsa pomanga, ndipo gawo lapitalo loyika mapaipi litatsukidwa bwino, filimu yapulasitiki itha kugwiritsidwa ntchito kusindikiza kuletsa kuipitsidwa ndi chilengedwe.
7. Malo ogwirira ntchito ayeretsedwe osatsukidwa bwino
Mosakayikira, msonkhano waukhondo uyenera kutsukidwa bwino musanayesedwe.Amafuna kuti opukuta omaliza azivala zovala zantchito zoyeretsera kuti athetse kuipitsidwa ndi thupi la munthu woyeretsayo.Zoyeretsa zimatha kukhala madzi apampopi, madzi oyera, zosungunulira zakuthupi, zotsukira zopanda ndale, ndi zina. Kwa iwo omwe ali ndi zofunikira zotsutsana ndi malo, pukutani bwino ndi nsalu yoviikidwa mumadzimadzi oletsa static.
Nthawi yotumiza: Jul-26-2023