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Qualification
Kupinda: Ziva zvinodikanwa.
Izwi rekuti qualification rinenge rave nezvarinoreva rakatsanangurwa muzita raro: Kuchengetedza uye kusimbisa kunaka kwemaitiro. MuGMP-inoenderana nemishonga uye kugadzirwa kwechikafu, chirimwa kana michina qualification inosungirwa. Isu tinokutsigira mukuita bvunzo dzese dzinodiwa dzemidziyo yako yeradobio pamwe nemagwaro.
Nekukodzera kwemudziyo, unoratidza kuti mudziyo wako wakaiswa (IQ) uye unoshanda nemazvo (OQ) zvinoenderana negwara reGMP. Chinhu chakakosha ndeye Performance Qualification (PQ). Iyi qualification yekuita chikamu chekusimbiswa kwese kugadzirwa kwemaitiro pamusoro penguva uye kune chimwe chigadzirwa. Mutengi-chaiwo mamiriro uye maitiro anotariswa uye akanyorwa.
Iwe unogona kuverenga kuti ndeapi masevhisi emunhu radobio anopa sechikamu cheIQ/OQ/PQ zvakadzama muchikamu chedu chehunyanzvi.
Sei kukodzera kweiyo radobio unit kwakakosha?
Hunhu hunoenderana hwezvigadzirwa zvatinogadzira - tisingataure nezve kuberekana kwemaitiro edu ekuyedza - kwakakosha kumarabhoritari uye zvivakwa zvekugadzira zvinoshanda zvinoenderana neGMP kana GLP zvinodiwa. Chisungo chinokonzeresa chekupa humbowo hunotsigira chinoda huwandu hukuru hwebvunzo dzeyuniti kuti dziitwe uye kurekodhwa chaizvo. RADOBIO inogona kukubatsira zvakanyanya kuderedza basa rakabatana neakakodzera uye anosimbisa zvikamu.
IQ, OQ uye PQ zvinorevei?
IQ - Kuiswa qualification
IQ, inomiririra Kuiswa Kwekufanirwa, inosimbisa kuti iyo unit yakaiswa zvakanaka zvinoenderana nezvinodiwa nevatengi kusanganisira zvinyorwa. Technician anotarisa kuti iyo unit yakaiswa nemazvo, sekutsanangurwa kwazvakaita muforodha yekufanirwa. Iwo maforodha ekufanirwa anogona kuodha pane imwe unit-chaiyo hwaro.
OQ - Inoshanda qualification
OQ, kana Operational Qualification, inotarisa uye inosimbisa kuti chikwata chiri kushanda nemazvo munzvimbo isina kurodzwa. Iwo maedzo anodiwa anowanikwa mune qualification folder.
PQ - Kufanirwa kwekuita
PQ, iyo inomiririra Performance Qualification, inotarisa uye inonyora iyo unit basa munzvimbo yakaremerwa pasi pezvinodiwa nemutengi. Iwo maedzo anodiwa anotsanangurwa nekubvumirana kubvumirana zvinoenderana nezvinodiwa nevatengi.
Ndezvipi zvikomborero zvauchawana kubva pakugadzirisa?
RADOBIO inogona kukubatsira zvakanyanya kuderedza basa rakabatana neakakodzera uye anosimbisa zvikamu.
Reproducible data
Reproducible data yako radobio unit - inofananidzwa nemaitiro ako uye zviyero
RADOBIO unyanzvi
Kushandiswa kweRADOBIO hunyanzvi panguva yekusimbisa uye kufanirwa
nyanzvi dzakakwanisa uye dzine ruzivo
Kuitwa nevanokwanisa uye vane ruzivo nyanzvi
Isu tinofara kukutsigira neyako IQ/OQ qualifications uye mukugadzira bvunzo zvirongwa zvePQ yako.
Ingotaura nesu.