UEduard Marty waseCodols uchaza ukuba izixhobo zokucoca amayeza kunye neelebhu zineempawu ezikhethekileyo zoyilo ekufuneka abavelisi baziqaphele ukuqinisekisa ukuba ziyathotyelwa.
Abavelisi bezixhobo balandela imigangatho engqongqo xa beyila kwaye besenza oomatshini bokucoca kwishishini lamayeza. Olu yilo lubalulekile kuba iimpawu ezahlukeneyo zibonelelwa ukuze zihambelane neMisebenzi yoKuvelisa eLungileyo (izixhobo ze-GMP) kunye neMisebenzi yoKusebenza eLungileyo yeLebhu (izixhobo ze-GLP).
Njengenxalenye yokuqinisekisa umgangatho, i-GMP ifuna ukuqinisekisa ukuba iimveliso ziveliswa ngendlela efanayo nelawulwayo ngokwemigangatho yomgangatho efanelekileyo ekusetyenzisweni kwemveliso naphantsi kweemeko ezifunekayo kurhwebo. Umenzi kufuneka alawule zonke izinto ezinokuchaphazela umgangatho wokugqibela wemveliso yamayeza, injongo ephambili kukunciphisa umngcipheko ekwenziweni kwemveliso yamayeza yonke.
Imithetho ye-GMP iyimfuneko kubo bonke abavelisi bamayeza. Kwizixhobo ze-GMP, le nkqubo ineenjongo ezithile ezongezelelweyo:
Kukho iintlobo ezahlukeneyo zeenkqubo zokucoca: ngesandla, endaweni (CIP) kunye nezixhobo ezikhethekileyo. Eli nqaku lithelekisa ukuhlamba izandla nokucoca ngezixhobo ze-GMP.
Nangona ukuhlamba izandla kunenzuzo yokuba nobuchule obuhlukeneyo, kukho iingxaki ezininzi ezifana nokuhlamba ixesha elide, iindleko eziphezulu zokulungisa, kunye nobunzima bokuvavanya kwakhona.
Umatshini wokuhlamba we-GMP ufuna utyalo-mali lokuqala, kodwa inzuzo yesixhobo kukuba kulula ukusivavanya kwaye yinkqubo ephindaphindwayo nefanelekileyo kuyo nayiphi na isixhobo, iphakheji kunye nenxalenye. Ezi mpawu zikuvumela ukuba ucoce kakuhle, wonge ixesha kunye nemali.
Iinkqubo zokucoca ngokuzenzekelayo zisetyenziswa kuphando nakwimizi-mveliso yamayeza ukucoca inani elikhulu lezinto. Oomatshini bokuhlamba basebenzisa amanzi, isepha kunye nesenzo soomatshini ukucoca iindawo ezimdaka zelebhu kunye neendawo zoshishino.
Njengoko kukho iintlobo ngeentlobo zeemashini zokuhlamba iimpahla ezisetyenziselwa izinto ezahlukeneyo kwimarike, kuphakama imibuzo eliqela: Yintoni umatshini wokuhlamba we-GMP? Kufuneka ndiwucoce nini ngesandla kwaye kufuneka ndiwuhlambe nini nge-GMP? Yintoni umahluko phakathi kwee-gasket ze-GMP kunye ne-GLP?
Isihloko 21, iiCandelo 211 kunye ne-212 zeKhowudi yeMimiselo yeFederal (CFR) ye-US Food and Drug Administration zichaza isakhelo solawulo esisebenzayo ekuthobeleni i-GMP yamayeza. Icandelo D leCandelo 211 liquka amacandelo amahlanu kwizixhobo kunye noomatshini, kubandakanya ii-gaskets.
21 ICandelo le-CFR 11 kufuneka liqwalaselwe njengoko linxulumene nokusetyenziswa kobuchwepheshe be-elektroniki. Lahlulwe laba ziinxalenye ezimbini eziphambili: ubhaliso lwe-elektroniki kunye notyikityo lwe-elektroniki.
Imigaqo ye-FDA yoyilo kunye nokwenziwa kwezixhobo kufuneka ihambelane nale migaqo ilandelayo:
Umahluko phakathi koomatshini bokuhlamba be-GMP kunye ne-GLP unokwahlulwahlulwa ube ziinkalo ezininzi, kodwa eyona ibalulekileyo luyilo lwabo loomatshini, amaxwebhu, kunye nesoftware, ukuzenzekela kunye nolawulo lwenkqubo. jonga itafile.
Ukuze zisetyenziswe ngokufanelekileyo, ii-washer ze-GMP kufuneka zichazwe ngokuchanekileyo, kuthintelwe iimfuno eziphezulu okanye ezo zingahlangabezani nemigangatho yolawulo. Ke ngoko, kubalulekile ukubonelela ngeNkcazelo yeMfuneko yoMsebenzisi (URS) efanelekileyo kwiprojekthi nganye.
Iinkcukacha mazichaze imigangatho ekufuneka ihlangatyezwe, uyilo loomatshini, ulawulo lwenkqubo, iinkqubo zesoftware kunye nolawulo, kunye namaxwebhu afunekayo. Izikhokelo ze-GMP zifuna iinkampani zenze uvavanyo lomngcipheko ukunceda ekuchongeni oomatshini bokuhlamba abafanelekileyo abahlangabezana neemfuno esele zichaziwe.
IiGasket zeGMP: Zonke iindawo zokufakela ii-clamp zivunyiwe yi-FDA kwaye zonke iipayipi ziyi-AISI 316L kwaye zingasuswa amanzi. Nika umzobo opheleleyo wentambo yesixhobo kunye nolwakhiwo ngokwe-GAMP5. Iitroli zangaphakathi okanye iirakhi zewasher yeGMP zenzelwe zonke iintlobo zezinto zenkqubo, oko kukuthi, izixhobo, amatanki, izikhongozeli, izinto zomgca webhotile, iglasi, njl.njl.
IiGasket zeGPL: Zenziwe ngokudibanisa izinto ezisemgangathweni ezivunyiweyo kancinci, umbhobho oqinileyo noguquguqukayo, imisonto kunye neentlobo ngeentlobo zeegasket. Ayizizo zonke iipayipi ezinokutsalwa amanzi kwaye uyilo lwazo aluhambelani neGAMP 5. Itroli yangaphakathi ye-washer yeGLP yenzelwe zonke iintlobo zezixhobo zelebhu.
Le webhusayithi igcina idatha efana neekuki zokusebenza kwewebhusayithi, kubandakanya uhlalutyo kunye nokwenza ngokwezifiso. Ngokusebenzisa le sayithi, uyavuma ngokuzenzekelayo ukusebenzisa kwethu iikuki.