U-Eduard Marty waseCodols uchaza ukuba izixhobo zokucoca amayeza kunye nelebhu zineempawu zoyilo ezikhethekileyo ekufuneka abavelisi bazi ngazo ukuze baqinisekise ukuthotyelwa.
Abavelisi bezixhobo balandela imigangatho engqongqo xa beyila kwaye besenza oomatshini bokucoca kushishino lwamayeza. Olu luyilo lubalulekile kuba iimpawu ezahlukeneyo zibonelelwa ukuthobela uMsebenzi wokuVelisa oLungileyo (izixhobo ze-GMP) kunye neZiqheliselo eziLungileyo zeLabhoratri (izixhobo ze-GLP).
Njengenxalenye yoqinisekiso lomgangatho, i-GMP ifuna ukuqinisekisa ukuba iimveliso ziveliswa ngendlela efanayo kunye nokulawulwa kwemigangatho yomgangatho ofanelekileyo kusetyenziso olucetywayo lwemveliso naphantsi kweemeko eziyimfuneko kurhwebo. Umenzi kufuneka alawule zonke izinto ezinokuchaphazela umgangatho wokugqibela wemveliso yeyeza, kunye nenjongo ephambili yokunciphisa umngcipheko ekwenzeni yonke imveliso yeyeza.
Imigaqo ye-GMP inyanzelekile kubo bonke abavelisi bamayeza. Kwizixhobo ze-GMP, inkqubo ineenjongo ezithile ezongezelelweyo:
Kukho iintlobo ezahlukeneyo zeenkqubo zokucoca: manual, in-place (CIP) kunye nezixhobo ezizodwa. Eli nqaku lithelekisa ukuhlamba izandla nokucoca ngezixhobo ze-GMP.
Ngelixa ukuhlamba izandla kunenzuzo yokuguquguquka, kukho izinto ezininzi eziphazamisayo ezifana namaxesha amade okuhlamba, iindleko eziphezulu zokulondoloza, kunye nobunzima bokuvavanya kwakhona.
Umatshini wokuhlamba we-GMP ufuna utyalo-mali lokuqala, kodwa inzuzo yesixhobo kukuba kulula ukuvavanya kwaye yinkqubo yokuvelisa kunye nefanelekileyo nayiphi na isixhobo, iphakheji kunye necandelo. Ezi mpawu zikuvumela ukuba wenze ngcono ukucoca, ukonga ixesha kunye nemali.
Iinkqubo zokucoca ngokuzenzekelayo zisetyenziselwa uphando kunye nezityalo zokuvelisa amayeza ukucoca inani elikhulu lezinto. Oomatshini bokuhlamba basebenzisa amanzi, isicoci kunye nesenzo soomatshini ukucoca imiphezulu kwinkunkuma yaselabhoratri kunye neendawo zoshishino.
Ngoluhlu olubanzi loomatshini bokuhlamba bezicelo ezahlukeneyo kwimarike, kuphakama imibuzo emininzi: Yintoni umatshini wokuhlamba we-GMP? Ingaba ndifuna nini ukucocwa ngesandla kwaye ndifuna nini ukuvaswa kwe-GMP? Yintoni umahluko phakathi kwe-GMP kunye ne-GLP gaskets?
Isihloko se-21, iSahlulo se-211 kunye ne-212 yeKhowudi ye-Federal Regulations (CFR) ye-US Food and Drug Administration ichaza isakhelo esilawulayo esisebenzayo kwi-GMP yokuthotyelwa kweziyobisi. Icandelo D leSigaba 211 libandakanya amacandelo amahlanu ezixhobo kunye noomatshini, kubandakanywa iigaskets.
21 CFR iSigaba 11 kufuneka kwakhona sithathelwe ingqalelo njengoko sinxulumene nokusetyenziswa kobuchwepheshe be-elektroniki. Yahlulwe yangamacandelo amabini aphambili: ubhaliso lwe-elektroniki kunye notyikityo lwe-elektroniki.
Imimiselo ye-FDA yoyilo kunye nokwenziwa kwezixhobo kufuneka kwakhona ihambelane nezi zikhokelo zilandelayo:
Umahluko phakathi kwe-GMP kunye noomatshini bokuhlamba be-GLP unokwahlulwa ngokwemiba emininzi, kodwa eyona nto ibalulekileyo luyilo lwabo lomatshini, amaxwebhu, kunye nesoftware, i-automation kunye nolawulo lwenkqubo. bona itafile.
Ukusetyenziswa ngokufanelekileyo, i-GMP washers kufuneka icaciswe ngokuchanekileyo, ukuphepha iimfuno eziphezulu okanye ezo zingahlangabezani nemigangatho yokulawula. Ke ngoko, kubalulekile ukubonelela ngeNgcaciso efanelekileyo yoMsebenzisi (i-URS) kwiprojekthi nganye.
Iinkcukacha kufuneka zichaze imigangatho ekufuneka ifikelelwe, uyilo lomatshini, ulawulo lwenkqubo, isoftware kunye neenkqubo zolawulo, kunye namaxwebhu afunekayo. Izikhokelo ze-GMP zifuna ukuba iinkampani zenze uvavanyo lomngcipheko ukunceda ukuchonga oomatshini bokuhlamba abafanelekileyo abahlangabezana neemfuno esele zichaziwe.
IiGaskets ze-GMP: Zonke iindawo ezifakela i-clamp zivunyiwe yi-FDA kwaye yonke imibhobho yi-AISI 316L kwaye inokutsalwa. Nika isixhobo esipheleleyo somzobo wocingo kunye nesakhiwo ngokuhambelana ne-GAMP5. Iitroli zangaphakathi okanye ii-racks ze-washer ye-GMP zenzelwe zonke iintlobo zamacandelo enkqubo, oko kukuthi izitya, iitanki, izikhongozeli, iinqununu zomgca weebhotile, iglasi, njl.
I-GPL Gaskets: Yenziwe ngokudityaniswa kwamacandelo asemgangathweni avunyiweyo ngokuyinxenye, umbhobho oqinileyo kunye oguquguqukayo, iintambo kunye neentlobo ezahlukeneyo zeegaskets. Ayiyiyo yonke imibhobho ehambisa amanzi kwaye uyilo lwabo aluhambelani ne-GAMP 5. Itroli yangaphakathi ye-GLP yewasha yenzelwe zonke iintlobo zemathiriyeli yaselabhoratri.
Le webhusayithi igcina idatha efana necookies ekusebenzeni kwewebhusayithi, kubandakanya uhlalutyo kunye nobuntu. Ngokusebenzisa le sayithi, uvuma ngokuzenzekelayo ukusebenzisa kwethu iikuki.