{"id":18745,"date":"2026-11-11T22:39:22","date_gmt":"2026-11-11T21:39:22","guid":{"rendered":"https:\/\/www.s-vt.net\/oq-kvalifikace-provozu-operational-qualification\/"},"modified":"2026-11-11T23:14:10","modified_gmt":"2026-11-11T22:14:10","slug":"operational-qualification","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/cs\/operational-qualification\/","title":{"rendered":"OQ \u2013 Kvalifikace provozu (Operational Qualification)"},"content":{"rendered":"<div style='' class=''><section class='page-content' style=''  ><section class='container'><div style='' class=''><div class='row' style=''><div style='' class=''><div class='col-md-12 ' style=''><div style='' class=''><div class='cma-wysiwyg-editor'><p class=\"svt-lead2\">Kvalifikace provozu (OQ) je dokumentovan\u00fd doklad, \u017ee prostory, syst\u00e9my a za\u0159\u00edzen\u00ed v nainstalovan\u00e9m nebo upraven\u00e9m proveden\u00ed funguj\u00ed v cel\u00e9m zam\u00fd\u0161len\u00e9m provozn\u00edm rozsahu podle p\u0159edpis\u016f.<\/p><div class=\"svt-ptiles\"><div class=\"svt-ptile\"><i class=\"fa fa-cogs\" aria-hidden=\"true\"><\/i><strong>Kontrola funkc\u00ed<\/strong><span>Shoda s funkcemi po\u017eadovan\u00fdmi ve specifikaci po\u017eadavk\u016f.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-tachometer\" aria-hidden=\"true\"><\/i><strong>Kalibrace<\/strong><span>Kalibrace m\u011b\u0159ic\u00edch m\u00edst a stanoven\u00ed interval\u016f.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><strong>Protokoly a zpr\u00e1va<\/strong><span>Zku\u0161ebn\u00ed protokoly, provozn\u00ed den\u00edk a zpr\u00e1va OQ.<\/span><\/div><\/div><h2>Definice kvalifikace provozu<\/h2><div class=\"svt-kgrid svt-kgrid-2\"><div class=\"svt-kcard\"><i class=\"fa fa-book\" aria-hidden=\"true\"><\/i><h3>Aide-M\u00e9moire GMP<\/h3><p>\u201eDokumentovan\u00fd doklad, \u017ee prostory, syst\u00e9my a za\u0159\u00edzen\u00ed v nainstalovan\u00e9m, resp. upraven\u00e9m proveden\u00ed funguj\u00ed v cel\u00e9m zam\u00fd\u0161len\u00e9m provozn\u00edm rozsahu podle p\u0159edpis\u016f.\u201c<\/p><\/div><div class=\"svt-kcard\"><i class=\"fa fa-book\" aria-hidden=\"true\"><\/i><h3>Pokyny EU pro GMP, dopln\u011bk 15<\/h3><p>\u201eDokumentovan\u00e9 ov\u011b\u0159en\u00ed, \u017ee prostory, syst\u00e9my a za\u0159\u00edzen\u00ed, tak jak byly nainstalov\u00e1ny nebo upraveny, funguj\u00ed v r\u00e1mci zam\u00fd\u0161len\u00fdch provozn\u00edch rozsah\u016f podle o\u010dek\u00e1v\u00e1n\u00ed.\u201c<\/p><\/div><\/div><h2>Obsah OQ<\/h2><p class=\"svt-knote\"><strong>P\u0159edpoklad:<\/strong> f\u00e1ze <a href=\"https:\/\/www.s-vt.net\/cs\/installation-qualification\/\">IQ<\/a> byla \u00fasp\u011b\u0161n\u011b dokon\u010dena. N\u00e1sledn\u011b OQ ov\u011b\u0159uje, zda funkce technick\u00e9ho syst\u00e9mu odpov\u00edd\u00e1 <a href=\"https:\/\/www.s-vt.net\/cs\/plant-engineering-project-execution\/#lastenheft\">specifikaci po\u017eadavk\u016f<\/a> a funkc\u00edm v n\u00ed po\u017eadovan\u00fdm.<\/p><div class=\"svt-kgrid svt-kgrid-3\"><div class=\"svt-kcard\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><h3>Pl\u00e1nov\u00e1n\u00ed a dokumentace<\/h3><ul class=\"svt-klist\"><li>pl\u00e1n proveden\u00ed OQ<\/li><li>zku\u0161ebn\u00ed protokoly pro jednotliv\u00e9 funk\u010dn\u00ed zkou\u0161ky<\/li><li>zalo\u017een\u00ed provozn\u00edho den\u00edku<\/li><li>kontrola technick\u00e9 dokumentace dodavatele<\/li><li>kontrola \u00faplnosti<\/li><li>zpr\u00e1va o proveden\u00ed OQ<\/li><\/ul><\/div><div class=\"svt-kcard\"><i class=\"fa fa-cogs\" aria-hidden=\"true\"><\/i><h3>Funk\u010dn\u00ed zkou\u0161ky<\/h3><ul class=\"svt-klist\"><li>ov\u011b\u0159en\u00ed jednotliv\u00fdch funkc\u00ed<\/li><li>identifikace a ov\u011b\u0159en\u00ed funkc\u00ed ovliv\u0148uj\u00edc\u00edch kvalitu<\/li><li>ov\u011b\u0159en\u00ed v\u00fdkonov\u00fdch parametr\u016f<\/li><li>ov\u011b\u0159en\u00ed podm\u00ednek okol\u00ed<\/li><li>ov\u011b\u0159en\u00ed elektromagnetick\u00e9 kompatibility<\/li><li>ov\u011b\u0159en\u00ed anal\u00fdzy rizik<\/li><\/ul><\/div><div class=\"svt-kcard\"><i class=\"fa fa-wrench\" aria-hidden=\"true\"><\/i><h3>Kalibrace a provoz<\/h3><ul class=\"svt-klist\"><li>kalibrace m\u011b\u0159ic\u00edch m\u00edst a stanoven\u00ed kalibra\u010dn\u00edch interval\u016f<\/li><li>pracovn\u00ed postupy dopl\u0148uj\u00edc\u00ed n\u00e1vody k obsluze<\/li><li>\u00faprava pracovn\u00edch postup\u016f pro kalibraci a \u00fadr\u017ebu<\/li><\/ul><\/div><\/div><h2>P\u0159ehled pr\u016fb\u011bhu kvalifikace<\/h2><ol class=\"svt-steps\"><li><span class=\"svt-step-n\">1<\/span><strong>RA \u2013 Anal\u00fdza rizik<\/strong><span class=\"svt-step-tx\">Rozpoznat a vyhodnotit rizika d\u0159\u00edve, ne\u017e je n\u00e1vrh definitivn\u00ed.<\/span><\/li><li><span class=\"svt-step-n\">2<\/span><strong><a href=\"https:\/\/www.s-vt.net\/cs\/design-qualification\/\">DQ \u2013 Kvalifikace n\u00e1vrhu<\/a><\/strong><span class=\"svt-step-tx\">Doklad, \u017ee n\u00e1vrh je vhodn\u00fd pro zam\u00fd\u0161len\u00e9 pou\u017eit\u00ed.<\/span><\/li><li><span class=\"svt-step-n\">3<\/span><strong><a href=\"https:\/\/www.s-vt.net\/cs\/installation-qualification\/\">IQ \u2013 Kvalifikace instalace<\/a><\/strong><span class=\"svt-step-tx\">Kontrola instalace podle objednac\u00ed dokumentace.<\/span><\/li><li><span class=\"svt-step-n\">4<\/span><strong>OQ \u2013 Kvalifikace provozu (tato str\u00e1nka)<\/strong><span class=\"svt-step-tx\">Kontrola zam\u00fd\u0161len\u00e9 funkce.<\/span><\/li><li><span class=\"svt-step-n\">5<\/span><strong><a href=\"https:\/\/www.s-vt.net\/cs\/process-qualification\/\">PQ \u2013 Kvalifikace funkce<\/a><\/strong><span class=\"svt-step-tx\">Doklad po\u017eadovan\u00e9ho v\u00fdkonu v provozu.<\/span><\/li><\/ol><div class=\"svt-pcta-btns\"><a class=\"svt-btn svt-btn-ghost\" style=\"flex:0 0 auto\" href=\"https:\/\/www.s-vt.net\/cs\/process-qualification\/\">Pokra\u010dovat na PQ \u2013 Kvalifikace funkce <i class=\"fa fa-arrow-right\" aria-hidden=\"true\"><\/i><\/a><\/div><p>f\u00e1ze <strong>SEEFRIED Verfahrenstechnik GmbH<\/strong> v\u00e1m pom\u016f\u017ee s tvorbou dokumentace a s ov\u011b\u0159en\u00edm kvalifikace provozu.<\/p><h2>\u010cast\u00e9 dotazy ke kvalifikaci provozu (OQ)<\/h2><h3>Co je kvalifikace provozu (OQ)?<\/h3><p>OQ je dokumentovan\u00fd doklad, \u017ee prostory, syst\u00e9my a za\u0159\u00edzen\u00ed v nainstalovan\u00e9m proveden\u00ed funguj\u00ed v cel\u00e9m zam\u00fd\u0161len\u00e9m provozn\u00edm rozsahu podle o\u010dek\u00e1v\u00e1n\u00ed (Pokyny EU pro GMP, dopln\u011bk 15).<\/p><h3>Co je p\u0159edpokladem pro OQ?<\/h3><p>Kvalifikace instalace (IQ) mus\u00ed b\u00fdt \u00fasp\u011b\u0161n\u011b dokon\u010dena.<\/p><h3>Co se p\u0159i OQ ov\u011b\u0159uje?<\/h3><p>Zda funkce za\u0159\u00edzen\u00ed odpov\u00eddaj\u00ed funkc\u00edm po\u017eadovan\u00fdm ve specifikaci po\u017eadavk\u016f \u2013 mimo jin\u00e9 jednotliv\u00e9 funkce, funkce ovliv\u0148uj\u00edc\u00ed kvalitu, v\u00fdkonov\u00e9 parametry, podm\u00ednky okol\u00ed, kalibrace m\u011b\u0159ic\u00edch m\u00edst a elektromagnetick\u00e1 kompatibilita.<\/p><h3>Jak\u00e9 dokumenty v r\u00e1mci OQ vznikaj\u00ed?<\/h3><p>Pl\u00e1n OQ, zku\u0161ebn\u00ed protokoly, kalibra\u010dn\u00ed intervaly, pracovn\u00ed postupy pro provoz, kalibraci a \u00fadr\u017ebu, provozn\u00ed den\u00edk a z\u00e1v\u011bre\u010dn\u00e1 zpr\u00e1va OQ.<\/p><h2 class=\"svt-pcta-h\">Kontaktujte n\u00e1s<\/h2><div class=\"svt-pcta svt-pcta-m\"><div class=\"svt-pcta-tx\">R\u00e1di v\u00e1m porad\u00edme v oblasti kvalifikace provozu \u2013 telefonicky na \u010d\u00edsle <a href=\"tel:+494203789492\">+49 4203 789492<\/a> nebo e-mailem na adrese <a href=\"mailto:i&#110;fo&#64;s&#45;&#118;&#116;.&#110;&#101;t\">i&#110;&#102;&#111;&#64;&#115;&#45;&#118;t.net<\/a>.<\/div><div class=\"svt-pcta-btns\"><a class=\"svt-btn svt-btn-primary\" href=\"https:\/\/www.s-vt.net\/cs\/contact\/?produkt=Verfahrenstechnische%20Beratung\">Odeslat popt\u00e1vku<\/a><a class=\"svt-btn svt-btn-ghost\" href=\"https:\/\/www.s-vt.net\/cs\/plant-engineering-project-execution\/#planung\">V\u0161echny slu\u017eby<\/a><\/div><\/div><h2>Dal\u0161\u00ed slu\u017eby<\/h2><div class=\"svt-sgrid\"><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/cs\/plant-engineering-project-execution\/#planung\"><span>Pl\u00e1nov\u00e1n\u00ed<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/cs\/plant-engineering-project-execution\/#basic-engineering\"><span>Basic engineering (z\u00e1kladn\u00ed projektov\u00e1n\u00ed)<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/cs\/plant-engineering-project-execution\/#konstruktion\"><span>Podpora p\u0159i konstrukci<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/cs\/plant-engineering-project-execution\/#beschaffung\"><span>Podpora p\u0159i n\u00e1kupu<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/cs\/plant-engineering-project-execution\/#lastenheft\"><span>Specifikace po\u017eadavk\u016f pro procesn\u00ed za\u0159\u00edzen\u00ed<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/cs\/plant-engineering-project-execution\/#terminplanung\"><span>Pl\u00e1nov\u00e1n\u00ed a kontrola term\u00edn\u016f<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/cs\/plant-engineering-project-execution\/#bauueberwachung\"><span>Stavebn\u00ed dozor<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/cs\/design-qualification\/\"><span>DQ \u2013 Kvalifikace n\u00e1vrhu<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/cs\/installation-qualification\/\"><span>IQ \u2013 Kvalifikace instalace<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/cs\/process-qualification\/\"><span>PQ \u2013 Kvalifikace funkce<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/cs\/process-optimisation\/\"><span>Optimalizace proces\u016f<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><\/div><script 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