U-Eduard Marty we-Codols uchaza ukuthi imishini yokuhlanza imithi nelebhu inezici zokuklama ezikhethekile abakhiqizi okudingeka baziqaphele ukuze baqinisekise ukuthotshelwa komthetho.
Abakhiqizi bemishini balandela izindinganiso eziqinile lapho beklama futhi bekhiqiza imishini yokuhlanza embonini yezemithi. Lo mklamo ubalulekile ngoba izici ezihlukahlukene zihlinzekwa ukuze zihambisane Nomkhuba Wokukhiqiza Okuhle (imishini ye-GMP) kanye Nomkhuba Omuhle Waselabhorethri (imishini ye-GLP).
Njengengxenye yokuqinisekiswa kwekhwalithi, i-GMP idinga ukuqinisekisa ukuthi imikhiqizo ikhiqizwa ngendlela efanayo futhi elawulwayo ukuya kumazinga ekhwalithi afanele ukusetshenziswa okuhlosiwe komkhiqizo nangaphansi kwezimo ezidingekayo zohwebo. Umkhiqizi kufanele alawule zonke izici ezingase zithinte ikhwalithi yokugcina yomkhiqizo womuthi, ngenhloso enkulu yokunciphisa ubungozi ekwenziweni kwawo wonke umkhiqizo womuthi.
Imithetho ye-GMP iyimpoqo kubo bonke abakhiqizi bemithi. Kumadivayisi e-GMP, inqubo inezinjongo ezithile ezengeziwe:
Kunezinhlobo ezahlukene zezinqubo zokuhlanza: imanuwali, endaweni (CIP) kanye nemishini ekhethekile. Lesi sihloko siqhathanisa ukugeza izandla nokuhlanza ngemishini ye-GMP.
Nakuba ukugeza izandla kunenzuzo yokuguquguquka, kuningi ukuphazamiseka okufana nezikhathi ezinde zokugeza, izindleko eziphezulu zokunakekela, kanye nobunzima bokuhlola kabusha.
Umshini wokuwasha we-GMP udinga ukutshalwa kwezimali kokuqala, kodwa inzuzo yemishini ukuthi kulula ukuyihlola futhi iyinqubo ekwazi ukukhiqiza futhi efanelekayo yanoma yiliphi ithuluzi, iphakheji kanye nengxenye. Lezi zici zikuvumela ukuthi uthuthukise ukuhlanza, ukonga isikhathi nemali.
Amasistimu okuhlanza okuzenzakalelayo asetshenziswa ocwaningweni nasezimbonini ezikhiqiza imithi ukuhlanza inani elikhulu lezinto. Imishini yokuwasha isebenzisa amanzi, okokuhlanza kanye nemishini ukuhlanza izindawo emfucumfucu waselabhorethri kanye nezingxenye zezimboni.
Ngezinhlobonhlobo zemishini yokuwasha yezinhlelo zokusebenza ezahlukene emakethe, kuphakama imibuzo eminingana: Uyini umshini wokuwasha we-GMP? Ngikudinga nini ukuhlanzwa ngesandla futhi ngidinga nini ukuwashwa kwe-GMP? Uyini umehluko phakathi kwe-GMP ne-GLP gaskets?
Isihloko sama-21, Izingxenye 211 kanye no-212 zeKhodi Yemithetho Yombuso (CFR) ye-US Food and Drug Administration ichaza uhlaka lokulawula olusebenza ekuthotshelweni kwe-GMP kwezidakamizwa. Isigaba D seNgxenye 211 sihlanganisa izigaba ezinhlanu zemishini nemishini, okuhlanganisa nama-gaskets.
21 CFR Ingxenye 11 kufanele futhi icatshangwe njengoba ihlobene nokusetshenziswa kobuchwepheshe be-elekthronikhi. Ihlukaniswe yaba izingxenye ezimbili eziyinhloko: ukubhaliswa nge-elekthronikhi kanye nesiginesha ye-elekthronikhi.
Imithetho ye-FDA yokuklama nokukhiqizwa kwamadivayisi kufanele futhi ihambisane nale mihlahlandlela elandelayo:
Umehluko phakathi kwemishini yokuwasha ye-GMP ne-GLP ingahlukaniswa ngezici eziningana, kodwa okubaluleke kakhulu ukwakheka kwayo kwemishini, imibhalo, kanye nesoftware, i-automation kanye nokulawulwa kwenqubo. bheka ithebula.
Ukuze usebenzise kahle, amawasha e-GMP kufanele acaciswe kahle, kugwenywe izidingo eziphakeme noma lawo angahlangabezani namazinga okulawula. Ngakho-ke, kubalulekile ukunikeza Ukucaciswa Kwesidingo Somsebenzisi esifanele (i-URS) kuphrojekthi ngayinye.
Imininingwane kufanele ichaze izindinganiso okufanele kuhlangatshezwane nazo, ukwakheka kwemishini, izilawuli zenqubo, isofthiwe nezinhlelo zokulawula, kanye nemibhalo edingekayo. Imihlahlandlela ye-GMP idinga ukuthi izinkampani zenze ukuhlolwa kobungozi ukuze zisize ukukhomba imishini yokuwasha efanelekile ehlangabezana nezidingo esezibaluliwe.
Ama-GMP Gaskets: Zonke izingxenye ezifaka i-clamp zivunyiwe yi-FDA futhi wonke amapayipi yi-AISI 316L futhi angakhanywa. Nikeza umdwebo ophelele wezintambo zensimbi kanye nesakhiwo ngokuya nge-GAMP5. Ama-trolleys angaphakathi noma ama-racks we-washer ye-GMP yakhelwe zonke izinhlobo zezingxenye zenqubo, okungukuthi izitsha, amathangi, iziqukathi, izingxenye zomugqa wamabhodlela, ingilazi, njll.
Ama-Gaskets e-GPL: Akhiqizwe ngenhlanganisela yezingxenye ezijwayelekile ezivunywe ngokwengxenye, ipayipi eliqinile neliguquguqukayo, izintambo kanye nezinhlobo ezahlukene zamagesi. Akuwona wonke amapayipi adonsa amanzi futhi ukwakheka kwawo akuhambelani ne-GAMP 5. I-GLP washer trolley yangaphakathi yakhelwe zonke izinhlobo zezinto zaselabhorethri.
Le webhusayithi igcina idatha efana namakhukhi ekusebenzeni kwewebhusayithi, okuhlanganisa izibalo nokwenza kube ngokwakho. Ngokusebenzisa le sayithi, uvuma ngokuzenzakalela ukusebenzisa kwethu amakhukhi.