Eduard Marty wa ku Codols akufotokoza kuti zida zoyeretsera mankhwala ndi labu zili ndi mawonekedwe apadera omwe opanga ayenera kudziwa kuti atsimikizire kuti akutsatira malamulo.
Opanga zida amatsatira miyezo yokhwima popanga ndi kupanga makina oyeretsera a makampani opanga mankhwala. Kapangidwe kameneka n'kofunika chifukwa zinthu zosiyanasiyana zimaperekedwa kuti zigwirizane ndi Good Manufacturing Practice (zida za GMP) ndi Good Laboratory Practice (zida za GLP).
Monga gawo la chitsimikizo cha khalidwe, GMP imafuna kuonetsetsa kuti zinthu zimapangidwa mofanana komanso motsogozedwa motsatira miyezo ya khalidwe yoyenera kugwiritsidwa ntchito kwa mankhwalawo komanso malinga ndi zomwe zimafunika pa malonda. Wopanga ayenera kuwongolera zinthu zonse zomwe zingakhudze mtundu womaliza wa mankhwalawo, cholinga chachikulu ndikuchepetsa chiopsezo pakupanga mankhwala onse.
Malamulo a GMP ndi ofunikira kwa opanga mankhwala onse. Pa zipangizo za GMP, njirayi ili ndi zolinga zina zapadera:
Pali mitundu yosiyanasiyana ya njira zoyeretsera: zamanja, zomwe zili m'malo mwake (CIP) ndi zida zapadera. Nkhaniyi ikuyerekeza kusamba m'manja ndi kuyeretsa pogwiritsa ntchito zida za GMP.
Ngakhale kusamba m'manja kuli ndi ubwino wosinthasintha, pali zovuta zambiri monga nthawi yayitali yosamba, ndalama zambiri zokonzera, komanso zovuta poyesanso.
Makina ochapira a GMP amafunika ndalama zoyambira, koma ubwino wa zidazi ndikuti ndi zosavuta kuyesa ndipo ndi njira yobwerezedwanso komanso yoyenera kugwiritsa ntchito chida chilichonse, phukusi ndi gawo lina. Zinthuzi zimakupatsani mwayi woyeretsa bwino, kusunga nthawi ndi ndalama.
Makina oyeretsera okha amagwiritsidwa ntchito m'mafakitale ofufuza ndi opanga mankhwala kuti ayeretse zinthu zambiri. Makina ochapira amagwiritsa ntchito madzi, sopo ndi makina kuti ayeretse malo kuchokera ku zinyalala za m'ma laboratories ndi m'mafakitale.
Popeza pali makina ochapira osiyanasiyana omwe amagwiritsidwa ntchito mosiyanasiyana pamsika, mafunso angapo amabuka: Kodi makina ochapira a GMP ndi chiyani? Kodi ndi liti pamene ndikufunika kutsuka ndi manja ndipo ndi liti pamene ndikufunika kutsuka ndi GMP? Kodi kusiyana kwa magasket a GMP ndi GLP ndi kotani?
Mutu 21, Gawo 211 ndi 212 la Malamulo a Federal Regulations (CFR) a US Food and Drug Administration amafotokoza malamulo omwe amagwiritsidwa ntchito potsatira malamulo a GMP pa mankhwala osokoneza bongo. Gawo D la Gawo 211 limaphatikizapo magawo asanu okhudza zida ndi makina, kuphatikizapo ma gasket.
Gawo 11 la CFR 21 liyeneranso kuganiziridwa chifukwa likukhudzana ndi kugwiritsa ntchito ukadaulo wamagetsi. Limagawidwa m'magawo awiri akuluakulu: kulembetsa pakompyuta ndi siginecha yamagetsi.
Malamulo a FDA pakupanga ndi kupanga zipangizo ayeneranso kutsatira malangizo otsatirawa:
Kusiyana pakati pa makina ochapira a GMP ndi GLP kungagawidwe m'mbali zingapo, koma chofunika kwambiri ndi kapangidwe ka makina awo, zolemba, komanso mapulogalamu, makina odzichitira okha ndi kuwongolera njira. Onani tebulo.
Kuti mugwiritse ntchito moyenera, makina ochapira a GMP ayenera kufotokozedwa bwino, kupewa zofunikira zapamwamba kapena zomwe sizikukwaniritsa miyezo yovomerezeka. Chifukwa chake, ndikofunikira kupereka Chidziwitso Chofunikira cha Ogwiritsa Ntchito (URS) choyenera pa ntchito iliyonse.
Mafotokozedwe ayenera kufotokoza miyezo yomwe iyenera kutsatiridwa, kapangidwe ka makina, zowongolera njira, mapulogalamu ndi makina owongolera, ndi zikalata zofunika. Malangizo a GMP amafuna kuti makampani azichita kuwunika zoopsa kuti athandize kupeza makina ochapira oyenera omwe akukwaniritsa zofunikira zomwe zatchulidwa kale.
Ma Gasket a GMP: Zigawo zonse zolumikizira ma clamp zavomerezedwa ndi FDA ndipo mapaipi onse ndi AISI 316L ndipo amatha kuchotsedwa madzi. Perekani chithunzi chokwanira cha mawaya a zida ndi kapangidwe kake malinga ndi GAMP5. Ma trolley kapena ma racks amkati mwa chotsukira cha GMP amapangidwira mitundu yonse ya zida zogwirira ntchito, mwachitsanzo ziwiya, matanki, zotengera, zida zolumikizira mabotolo, galasi, ndi zina zotero.
Ma Gasket a GPL: Opangidwa kuchokera ku zinthu zovomerezeka pang'ono, chitoliro cholimba komanso chosinthasintha, ulusi ndi mitundu yosiyanasiyana ya ma gasket. Si mapaipi onse omwe amatha kutulutsa madzi ndipo kapangidwe kake sikagwirizana ndi GAMP 5. Trolley yamkati ya washer ya GLP idapangidwira mitundu yonse ya zipangizo za labotale.
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