Eduard Marty wa ku Codols akufotokoza kuti zida zoyeretsera mankhwala ndi labu zili ndi mapangidwe apadera omwe opanga amayenera kudziwa kuti akutsatira.
Opanga zida amatsata miyezo yokhazikika popanga ndi kupanga makina oyeretsera amakampani opanga mankhwala. Mapangidwe awa ndi ofunikira chifukwa mawonekedwe osiyanasiyana amaperekedwa kuti azitsatira Good Production Practice (zida za GMP) ndi Good Laboratory Practice (zida za GLP).
Monga gawo la chitsimikizo chaubwino, GMP imafuna kuwonetsetsa kuti zinthu zikupangidwa mofananira komanso mowongoleredwa kuti zigwirizane ndi zomwe akufuna kugwiritsa ntchito komanso malinga ndi zofunikira pakugulitsa. Wopangayo ayenera kulamulira zinthu zonse zomwe zingakhudze khalidwe lomaliza la mankhwala, ndi cholinga chachikulu chochepetsera chiopsezo pakupanga mankhwala onse.
Malamulo a GMP ndi ovomerezeka kwa onse opanga mankhwala. Pazida za GMP, njirayi ili ndi zolinga zina zowonjezera:
Pali njira zosiyanasiyana zoyeretsera: pamanja, pamalo (CIP) ndi zida zapadera. Nkhaniyi ikuyerekeza kusamba m'manja ndi kuyeretsa ndi zida za GMP.
Ngakhale kuti kusamba m'manja kuli ndi ubwino wosinthasintha, pali zovuta zambiri monga nthawi yayitali yosamba, kukwera mtengo kwa kukonza, ndi kuvutika kuyesanso.
Makina ochapira a GMP amafunikira ndalama zoyambira, koma ubwino wa zidazo ndikuti ndizosavuta kuyesa ndipo ndi njira yobwereketsa komanso yoyenerera pa chida chilichonse, phukusi ndi chigawo chilichonse. Izi zimakupatsani mwayi wokonza zoyeretsa, kupulumutsa nthawi ndi ndalama.
Makina otsuka okha amagwiritsidwa ntchito pofufuza ndi kupanga mankhwala kuyeretsa zinthu zambiri. Makina ochapira amagwiritsa ntchito madzi, zotsukira ndi makina kuyeretsa malo kuchokera ku zinyalala za labotale ndi zigawo zamakampani.
Ndi makina ochapira osiyanasiyana amitundu yosiyanasiyana pamsika, mafunso angapo amabuka: Kodi makina ochapira a GMP ndi chiyani? Ndi liti pamene ndikufunika kuyeretsedwa pamanja ndipo ndifunika liti kutsuka kwa GMP? Kodi pali kusiyana kotani pakati pa GMP ndi GLP gaskets?
Mutu 21, Gawo 211 ndi 212 la Code of Federal Regulations (CFR) la US Food and Drug Administration limatanthauzira njira zoyendetsera GMP pamankhwala. Gawo D la Gawo 211 limaphatikizapo magawo asanu pazida ndi makina, kuphatikiza ma gaskets.
21 CFR Gawo 11 liyeneranso kuganiziridwa ngati likukhudzana ndi kugwiritsa ntchito matekinoloje amagetsi. Amagawidwa m'magawo awiri akuluakulu: kulembetsa pakompyuta ndi siginecha yamagetsi.
Malamulo a FDA pakupanga ndi kupanga zida ayeneranso kutsatira malangizo awa:
Kusiyanitsa pakati pa makina ochapira a GMP ndi GLP kumatha kugawidwa m'magawo angapo, koma chofunikira kwambiri ndi kapangidwe kawo ka makina, zolemba, komanso mapulogalamu, zodziwikiratu komanso kuwongolera njira. onani tebulo.
Kuti mugwiritse ntchito moyenera, ma washer a GMP ayenera kufotokozedwa molondola, kupewa zofunikira zapamwamba kapena zomwe sizikukwaniritsa miyezo yoyendetsera. Chifukwa chake, ndikofunikira kupereka Mafotokozedwe Ofunikira Ogwiritsa Ntchito (URS) pa projekiti iliyonse.
Zofunikira ziyenera kufotokozera miyezo yomwe iyenera kukwaniritsidwa, kapangidwe ka makina, kuwongolera kachitidwe, mapulogalamu ndi machitidwe owongolera, ndi zolemba zofunika. Malangizo a GMP amafuna kuti makampani aziwunika zomwe zingawopsezedwe kuti athe kuzindikira makina ochapira oyenera omwe amakwaniritsa zomwe zanenedwa kale.
Ma Gaskets a GMP: Zigawo zonse zotchingira zotchingira ndizovomerezeka ndi FDA ndipo mapaipi onse ndi AISI 316L ndipo amatha kutsanulidwa. Perekani chithunzi chathunthu cholumikizira zida ndi kapangidwe molingana ndi GAMP5. Ma trolleys amkati kapena ma racks a GMP washer amapangidwira mitundu yonse yazinthu zopangira, mwachitsanzo, ziwiya, akasinja, zotengera, zida zamabotolo, magalasi, ndi zina zambiri.
Ma Gaskets a GPL: Opangidwa kuchokera kumagulu ovomerezeka pang'ono, chitoliro cholimba komanso chosinthika, ulusi ndi mitundu yosiyanasiyana ya gaskets. Si mapaipi onse omwe amatha kuthira madzi ndipo mapangidwe ake sakugwirizana ndi GAMP 5. Trolley yamkati ya GLP washer idapangidwira mitundu yonse ya zida za labotale.
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