U-Eduard Marty waseCodols uchaza ukuthi imishini yokuhlanza imithi kanye nelebhu inezici ezikhethekile zokuklama okudingeka abakhiqizi baziqaphele ukuze baqinisekise ukuthi ziyalandelwa.
Abakhiqizi bemishini balandela izindinganiso eziqinile lapho beklama futhi bekhiqiza imishini yokuhlanza yemboni yezemithi. Lo mklamo ubalulekile ngoba izici ezahlukahlukene zinikezwa ukuze zihambisane ne-Good Manufacturing Practice (imishini ye-GMP) kanye ne-Good Laboratory Practice (imishini ye-GLP).
Njengengxenye yokuqinisekiswa kwekhwalithi, i-GMP idinga ukuqinisekisa ukuthi imikhiqizo ikhiqizwa ngendlela efanayo nelawulwayo ngokwezindinganiso zekhwalithi ezifanele ukusetshenziswa okuhlosiwe komkhiqizo nangaphansi kwezimo ezidingekayo zokuhweba. Umenzi kumele alawule zonke izinto ezingathinta ikhwalithi yokugcina yomkhiqizo wezokwelapha, ngenhloso eyinhloko yokunciphisa ubungozi ekukhiqizweni komkhiqizo wonke wezokwelapha.
Imithetho ye-GMP iyimpoqo kubo bonke abakhiqizi bemithi. Kumadivayisi e-GMP, inqubo inezinhloso ezithile ezengeziwe:
Kunezinhlobo ezahlukene zezinqubo zokuhlanza: ngesandla, endaweni (i-CIP) kanye nemishini ekhethekile. Lesi sihloko siqhathanisa ukugeza izandla nokuhlanza ngemishini ye-GMP.
Nakuba ukugeza izandla kunenzuzo yokuguquguquka, kunezinkinga eziningi ezifana nokugeza isikhathi eside, izindleko eziphezulu zokulungisa, kanye nobunzima bokuhlola kabusha.
Umshini wokuwasha we-GMP udinga ukutshalwa kwezimali kokuqala, kodwa inzuzo yale mishini ukuthi kulula ukuyihlola futhi iyinqubo ephindaphindwayo nefanelekile yanoma yiliphi ithuluzi, iphakheji kanye nengxenye. Lezi zici zikuvumela ukuthi uthuthukise ukuhlanza, wonge isikhathi nemali.
Izinhlelo zokuhlanza ezizenzakalelayo zisetshenziswa ocwaningweni kanye nasezimbonini zokukhiqiza imithi ukuhlanza inani elikhulu lezinto. Imishini yokuwasha isebenzisa amanzi, insipho kanye nesenzo somshini ukuhlanza izindawo ezisuka emfucumfucwini yelabhorethri kanye nezingxenye zezimboni.
Njengoba kunezinhlobo eziningi zemishini yokuwasha yezinhlelo zokusebenza ezahlukene emakethe, kuphakama imibuzo eminingana: Uyini umshini wokuwasha we-GMP? Kunini lapho ngidinga ukuhlanzwa ngesandla futhi nini lapho ngidinga ukuhlanzwa kwe-GMP? Uyini umehluko phakathi kwama-gasket e-GMP nama-GLP?
Isihloko 21, Izingxenye 211 kanye no-212 zeKhodi Yemithetho Kahulumeni (i-CFR) ye-US Food and Drug Administration zichaza uhlaka lokulawula olusebenza ekuhambisaneni ne-GMP yezidakamizwa. Isigaba D seNgxenye 211 sihlanganisa izingxenye ezinhlanu zemishini nemishini, kufaka phakathi ama-gasket.
Ingxenye 11 ye-CFR engu-21 kufanele icatshangelwe njengoba ihlobene nokusetshenziswa kobuchwepheshe be-elekthronikhi. Ihlukaniswe izingxenye ezimbili eziyinhloko: ukubhaliswa kwe-elekthronikhi kanye nokusayina kwe-elekthronikhi.
Imithethonqubo ye-FDA yokuklama nokukhiqizwa kwamadivayisi kumele futhi ihambisane neziqondiso ezilandelayo:
Umehluko phakathi kwemishini yokuwasha ye-GMP ne-GLP ungahlukaniswa ngezici eziningana, kodwa okubaluleke kakhulu ukwakheka kwayo kwemishini, imibhalo, kanye nesofthiwe, ukuzenzekela kanye nokulawula izinqubo. bheka ithebula.
Ukuze kusetshenziswe kahle, ama-washer e-GMP kumele achazwe kahle, kugwenywe izidingo eziphakeme noma lezo ezingahlangabezani nezindinganiso zomthetho. Ngakho-ke, kubalulekile ukuhlinzeka nge-User Requirement Specification (URS) efanele yephrojekthi ngayinye.
Imininingwane kufanele ichaze amazinga okufanele ahlangatshezwane nawo, ukwakheka kwemishini, izilawuli zenqubo, izinhlelo zesofthiwe nokulawula, kanye nemibhalo edingekayo. Iziqondiso ze-GMP zidinga izinkampani ukuthi zenze ukuhlolwa kwengozi ukusiza ekutholeni imishini yokuwasha efanelekile ehlangabezana nezidingo esezichaziwe kakade.
Ama-GMP Gaskets: Zonke izingxenye zokufaka i-clamp zivunyelwe yi-FDA futhi wonke amapayipi ayi-AISI 316L futhi angakhishwa amanzi. Nikeza umdwebo ophelele wezintambo zensimbi kanye nesakhiwo ngokusho kwe-GAMP5. Ama-trolley noma ama-rack angaphakathi e-GMP washer aklanyelwe zonke izinhlobo zezingxenye zenqubo, okungukuthi izitsha, amathangi, izitsha, izingxenye zomugqa wamabhodlela, ingilazi, njll.
Ama-Gasket e-GPL: Akhiwe ngenhlanganisela yezingxenye ezijwayelekile ezivunyelwe kancane, ipayipi eliqinile neliguquguqukayo, imicu kanye nezinhlobo ezahlukene zama-gasket. Akuwona wonke amapayipi angakhishwa amanzi futhi ukwakheka kwawo akuhambelani ne-GAMP 5. I-GLP washer inner trolley yenzelwe zonke izinhlobo zezinto zelebhu.
Le webhusayithi igcina idatha efana namakhukhi okusebenza kwewebhusayithi, okuhlanganisa ukuhlaziya kanye nokwenza kube ngokwakho. Ngokusebenzisa le sayithi, uyavuma ngokuzenzakalelayo ukusebenzisa kwethu amakhukhi.