Kuvaka imba yeGMP yakachena kunonetsa. Kwete chete inoda zero kusvibiswa, asi kunewo zvakawanda zvakawanda zvisingagoni kukanganisa. Naizvozvo, zvinotora nguva yakareba kupfuura mamwe mapurojekiti. Nguva yekuvaka uye zvinodiwa uye kuomarara kwemutengi kuchakanganisa zvakananga nguva yekuvaka.
1. Zvinotora nguva yakareba sei kuvaka imba yeGMP yakachena?
(1). Chekutanga pane zvese, zvinoenderana nehuremu hwese hwenzvimbo yeGMP yakachena kamuri uye chaiyo inoshanda zvinodiwa. Wekishopu ingangoita 1,000 square metres uye 3,000 square metres inotora inenge mwedzi miviri, uye yakakura inotora inenge mwedzi mitatu kusvika mina.
(2). Chechipiri, zvakaoma kuvaka GMP yakachena kamuri kana iwe uchida kuchengetedza mari iwe pachako. Zvinokurudzirwa kuwana yakachena kamuri engineering kambani kuti ikubatsire kuronga nekugadzira.
(3). Makamuri akachena eGMP anoshandiswa mumishonga, chikafu, kuchengetedza ganda uye mamwe maindasitiri ekugadzira. Chekutanga, musangano wese wekugadzira unofanirwa kugovaniswa zvakarongeka zvinoenderana nemaitiro ekugadzira uye mirau yekugadzira. Kuronga kwedunhu kunofanirwa kuona kushanda nesimba uye kusimba, kudzivirira kukanganiswa kwemachaneli emaoko uye kutakura zvinhu; uye kuiswa nenzira yakatsetseka zvinoenderana nemaitiro ekugadzira kudzikisa kumonyoroka uye kutendeuka kwemaitiro ekugadzira.
(4). Zvemidziyo uye midziyo yekuchenesa makamuri eGMP yakachena kamuri yekirasi 100,000 uye pamusoro, anogona kurongwa munzvimbo ino. Makamuri akachena epamusoro-chikamu chekirasi 100,000 uye kirasi 1,000 anofanirwa kuvakwa kunze kwenzvimbo yakachena, uye hutsanana hwavo hunogona kuva nhanho imwe yakaderera pane nzvimbo yekugadzira; maturusi ekuchenesa kuchenesa, makamuri ekuchengetera, uye makamuri ekugadzirisa haana kukodzera kuvakwa munzvimbo yakachena yekugadzira; chiyero chehutsanana chekuchenesa uye kuomesa makamuri embatya dzakachena kazhinji inogona kunge yakaderera pane imwe nzvimbo yekugadzira, ukuwo hutsanana hutsanana hwemakamuri ekumisikidza uye sterilization yembatya dzebvunzo dzisina kuchena dzinofanira kufanana nenzvimbo yekugadzira.
(5). Zvakaoma kwazvo kuvaka yakakwana GMP yakachena kamuri. Kwete chete ukuru hwenzvimbo yemiti inofanirwa kutariswa, asiwo inofanirwa kugadziriswa maererano nenzvimbo dzakasiyana.
2. Matanho mangani aripo mukuvakwa kwekamuri rakachena reGMP?
(1). Process midziyo
Panofanirwa kuve nekamuri rakachena reGMP rine nzvimbo yakakwana yekugadzirwa uye kuyerwa kwemhando uye kuongororwa, uye mvura yakanaka, magetsi uye gasi. Zvinoenderana nezvinodiwa tekinoroji tekinoroji uye mhando, nzvimbo yekugadzira yakakamurwa kuita nhanho dzehutsanana, kazhinji yakakamurwa mukirasi 100, 1000, 10000 uye 100000. Nzvimbo yakachena inofanira kuchengetedza kudzvanywa kwakanaka.
(2). Zvido zvekugadzira
①. Urongwa hwekuvaka uye kuronga nzvimbo kunofanirwa kuve nekubatana kwakakodzera. Chimiro chikuru chegmp chirimwa hachina kukodzera kushandisa mukati uye kunze kwemadziro mitoro.
②. Nzvimbo yakachena inofanira kunge yakashongedzerwa nehunyanzvi partitions kana tekinoroji alleys yekurongeka kweventilation ducts uye mapaipi akasiyana.
③. Iko kushongedzwa kwenzvimbo yakachena kunofanirwa kushandisa zvinhu zvine chisimbiso chakanaka uye diki deformation pasi pemhedzisiro yekushisa uye humidity shanduko.
(2) Kuvaka zvinodiwa
①. Iyo gmp chirimwa chepasi chinofanirwa kunge chakanyatso kutenderedzwa, chakafuratira, chisina gap, chisingapfeke, chinodzivirira corrosion, chinodzivirira-simba, chisingaendere kumagetsi akamira, uye nyore kuchenesa.
②. Iko kushongedzwa kwepamusoro kweiyo exhaust duct, kudzoka kwemhepo duct, uye kugovera mweya duct kunofanirwa kuve 20% kunoenderana nekudzoka kwese uye kugovera mweya system uye nyore kuchenesa.
③. Mapombi akasiyana-siyana, zvigadziriso zvemwenje, mavhavha emhepo, uye zvimwe zvivakwa zvakajairika mukati mekamuri rakachena zvinofanirwa kunyatsotariswa panguva yekugadzira uye kuisa kudzivirira nzvimbo dzinonetsa kuwana.
Kazhinji, zvinodikanwa zveGMP yakachena kamuri zvakakwirira pane izvo zveyakajairwa yakachena kamuri. Chikamu chimwe nechimwe chekuvaka chakasiyana, uye zvinodiwa zvinosiyana, zvinoda kuteedzera zviyero zvinoenderana padanho rega rega.
Nguva yekutumira: Aug-28-2025