{"id":19025,"date":"2026-11-11T22:51:56","date_gmt":"2026-11-11T21:51:56","guid":{"rendered":"https:\/\/www.s-vt.net\/oq-operasyonel-kalifikasyon-operational-qualification\/"},"modified":"2026-11-11T23:21:12","modified_gmt":"2026-11-11T22:21:12","slug":"operasyonel-kalifikasyon","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/tr\/operasyonel-kalifikasyon\/","title":{"rendered":"OQ \u2013 Operasyonel Kalifikasyon (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\">Operasyonel kalifikasyon (OQ), tesislerin, sistemlerin ve ekipman\u0131n kurulmu\u015f veya modifiye edilmi\u015f haliyle \u00f6ng\u00f6r\u00fclen \u00e7al\u0131\u015fma aral\u0131\u011f\u0131n\u0131n tamam\u0131nda ama\u00e7land\u0131\u011f\u0131 \u015fekilde \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131n belgelenmi\u015f kan\u0131t\u0131d\u0131r.<\/p><div class=\"svt-ptiles\"><div class=\"svt-ptile\"><i class=\"fa fa-cogs\" aria-hidden=\"true\"><\/i><strong>Fonksiyonlar\u0131 test etme<\/strong><span>Gereksinim \u015fartnamesinde istenen fonksiyonlarla uygunluk.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-tachometer\" aria-hidden=\"true\"><\/i><strong>Kalibrasyon<\/strong><span>\u00d6l\u00e7\u00fcm noktalar\u0131n\u0131 kalibre etme ve kalibrasyon aral\u0131klar\u0131n\u0131 belirleme.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><strong>Protokoller ve rapor<\/strong><span>Test protokolleri, kay\u0131t defteri ve OQ raporu.<\/span><\/div><\/div><h2>Operasyonel kalifikasyonun tan\u0131mlar\u0131<\/h2><div class=\"svt-kgrid svt-kgrid-2\"><div class=\"svt-kcard\"><i class=\"fa fa-book\" aria-hidden=\"true\"><\/i><h3>Aide Memoire GMP<\/h3><p>\u201cTesislerin, sistemlerin ve ekipman\u0131n kurulmu\u015f veya modifiye edilmi\u015f haliyle \u00f6ng\u00f6r\u00fclen \u00e7al\u0131\u015fma aral\u0131\u011f\u0131n\u0131n tamam\u0131nda ama\u00e7land\u0131\u011f\u0131 \u015fekilde \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131n belgelenmi\u015f kan\u0131t\u0131.\u201d<\/p><\/div><div class=\"svt-kcard\"><i class=\"fa fa-book\" aria-hidden=\"true\"><\/i><h3>EU-GMP K\u0131lavuzu, Ek 15<\/h3><p>\u201cTesislerin, sistemlerin ve ekipman\u0131n kurulmu\u015f veya modifiye edilmi\u015f haliyle, \u00f6ng\u00f6r\u00fclen \u00e7al\u0131\u015fma aral\u0131klar\u0131 i\u00e7inde beklendi\u011fi \u015fekilde \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131n belgelenmi\u015f do\u011frulamas\u0131.\u201d<\/p><\/div><\/div><h2>OQ'nun i\u00e7eri\u011fi<\/h2><p class=\"svt-knote\"><strong>\u00d6n ko\u015ful:<\/strong> \u00d6nceki ad\u0131m olan <a href=\"https:\/\/www.s-vt.net\/tr\/kurulum-kalifikasyonu\/\">IQ<\/a> ba\u015far\u0131yla tamamlanm\u0131\u015f olmal\u0131d\u0131r. Ard\u0131ndan OQ, teknik sistemin i\u015flevinin <a href=\"https:\/\/www.s-vt.net\/tr\/tesis-muhendisligi-proje-yonetimi\/#lastenheft\">gereksinim \u015fartnamesinde<\/a> istenen i\u015flevlerle uyumlu olup olmad\u0131\u011f\u0131n\u0131 kontrol eder.<\/p><div class=\"svt-kgrid svt-kgrid-3\"><div class=\"svt-kcard\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><h3>Planlama ve dok\u00fcmantasyon<\/h3><ul class=\"svt-klist\"><li>OQ'nun uygulanmas\u0131na y\u00f6nelik plan<\/li><li>tek tek fonksiyon testleri i\u00e7in test protokolleri<\/li><li>bir kay\u0131t defteri olu\u015fturulmas\u0131<\/li><li>tedarik\u00e7inin teknik dok\u00fcmantasyonunun kontrol\u00fc<\/li><li>eksiksizlik kontrol\u00fc<\/li><li>OQ'nun uygulanmas\u0131na ili\u015fkin rapor<\/li><\/ul><\/div><div class=\"svt-kcard\"><i class=\"fa fa-cogs\" aria-hidden=\"true\"><\/i><h3>Fonksiyon testleri<\/h3><ul class=\"svt-klist\"><li>tekil fonksiyonlar\u0131n kontrol\u00fc<\/li><li>kaliteyi etkileyen fonksiyonlar\u0131n belirlenmesi ve test edilmesi<\/li><li>performans parametrelerinin kontrol\u00fc<\/li><li>ortam ko\u015fullar\u0131n\u0131n kontrol\u00fc<\/li><li>elektromanyetik uyumlulu\u011fun kontrol\u00fc<\/li><li>risk analizinin g\u00f6zden ge\u00e7irilmesi<\/li><\/ul><\/div><div class=\"svt-kcard\"><i class=\"fa fa-wrench\" aria-hidden=\"true\"><\/i><h3>Kalibrasyon ve i\u015fletme<\/h3><ul class=\"svt-klist\"><li>\u00f6l\u00e7\u00fcm noktalar\u0131n\u0131n kalibrasyonu ve kalibrasyon aral\u0131klar\u0131n\u0131n belirlenmesi<\/li><li>kullan\u0131m k\u0131lavuzlar\u0131n\u0131 tamamlayan \u00e7al\u0131\u015fma talimatlar\u0131<\/li><li>kalibrasyon ve bak\u0131m \u00e7al\u0131\u015fma talimatlar\u0131n\u0131n uyarlanmas\u0131<\/li><\/ul><\/div><\/div><h2>Kalifikasyon s\u00fcrecine genel bak\u0131\u015f<\/h2><ol class=\"svt-steps\"><li><span class=\"svt-step-n\">1<\/span><strong>RA \u2013 Risk analizi<\/strong><span class=\"svt-step-tx\">Tasar\u0131m kesinle\u015fmeden \u00f6nce riskleri belirleme ve de\u011ferlendirme.<\/span><\/li><li><span class=\"svt-step-n\">2<\/span><strong><a href=\"https:\/\/www.s-vt.net\/tr\/tasarim-kalifikasyonu\/\">DQ \u2013 Tasar\u0131m kalifikasyonu<\/a><\/strong><span class=\"svt-step-tx\">Tasar\u0131m\u0131n kullan\u0131m amac\u0131na uygun oldu\u011funun kan\u0131t\u0131.<\/span><\/li><li><span class=\"svt-step-n\">3<\/span><strong><a href=\"https:\/\/www.s-vt.net\/tr\/kurulum-kalifikasyonu\/\">IQ \u2013 Kurulum kalifikasyonu<\/a><\/strong><span class=\"svt-step-tx\">Kurulumun sipari\u015f belgelerine g\u00f6re kontrol\u00fc.<\/span><\/li><li><span class=\"svt-step-n\">4<\/span><strong>OQ \u2013 Operasyonel kalifikasyon (bu sayfa)<\/strong><span class=\"svt-step-tx\">\u00d6ng\u00f6r\u00fclen \u00e7al\u0131\u015fma \u015feklinin kontrol\u00fc.<\/span><\/li><li><span class=\"svt-step-n\">5<\/span><strong><a href=\"https:\/\/www.s-vt.net\/tr\/performans-kalifikasyonu\/\">PQ \u2013 Performans kalifikasyonu<\/a><\/strong><span class=\"svt-step-tx\">\u0130\u015fletmede gereken performans\u0131n kan\u0131t\u0131.<\/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\/tr\/performans-kalifikasyonu\/\">Sonraki ad\u0131m: PQ \u2013 Performans kalifikasyonu <i class=\"fa fa-arrow-right\" aria-hidden=\"true\"><\/i><\/a><\/div><p>\u00d6nceki ad\u0131m olan <strong>SEEFRIED Verfahrenstechnik GmbH<\/strong> olarak, operasyonel kalifikasyonun dok\u00fcmantasyonunun haz\u0131rlanmas\u0131nda ve kontrol\u00fcnde size destek veriyoruz.<\/p><h2>Operasyonel kalifikasyon (OQ) hakk\u0131nda s\u0131k sorulan sorular<\/h2><h3>Operasyonel kalifikasyon (OQ) nedir?<\/h3><p>OQ, tesislerin, sistemlerin ve ekipman\u0131n kurulmu\u015f haliyle \u00f6ng\u00f6r\u00fclen \u00e7al\u0131\u015fma aral\u0131\u011f\u0131n\u0131n tamam\u0131nda beklendi\u011fi \u015fekilde \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131n belgelenmi\u015f kan\u0131t\u0131d\u0131r (EU-GMP K\u0131lavuzu, Ek 15).<\/p><h3>OQ'nun \u00f6n ko\u015fulu nedir?<\/h3><p>Kurulum kalifikasyonunun (IQ) ba\u015far\u0131yla tamamlanm\u0131\u015f olmas\u0131 gerekir.<\/p><h3>OQ'da neler test edilir?<\/h3><p>Tesisin fonksiyonlar\u0131n\u0131n gereksinim \u015fartnamesinde istenen i\u015flevlere uygun olup olmad\u0131\u011f\u0131 \u2013 di\u011ferlerinin yan\u0131 s\u0131ra tekil fonksiyonlar, kaliteyi etkileyen fonksiyonlar, performans parametreleri, ortam ko\u015fullar\u0131, \u00f6l\u00e7\u00fcm noktalar\u0131n\u0131n kalibrasyonu ve elektromanyetik uyumluluk.<\/p><h3>OQ'da hangi belgeler olu\u015fturulur?<\/h3><p>OQ plan\u0131, test protokolleri, kalibrasyon aral\u0131klar\u0131, i\u015fletme, kalibrasyon ve bak\u0131m i\u00e7in \u00e7al\u0131\u015fma talimatlar\u0131, kay\u0131t defteri ve nihai OQ raporu.<\/p><h2 class=\"svt-pcta-h\">Bizimle ileti\u015fime ge\u00e7in<\/h2><div class=\"svt-pcta svt-pcta-m\"><div class=\"svt-pcta-tx\">Operasyonel kalifikasyon konusunda size memnuniyetle dan\u0131\u015fmanl\u0131k veriyoruz \u2013 telefonla <a href=\"tel:+494203789492\">+49 4203 789492<\/a> veya e-posta ile <a href=\"mailto:inf&#111;&#64;&#115;&#45;v&#116;&#46;&#110;&#101;&#116;\">inf&#111;&#64;s-vt.&#110;e&#116;<\/a>.<\/div><div class=\"svt-pcta-btns\"><a class=\"svt-btn svt-btn-primary\" href=\"https:\/\/www.s-vt.net\/tr\/iletisim\/?produkt=Verfahrenstechnische%20Beratung\">Talep g\u00f6nderin<\/a><a class=\"svt-btn svt-btn-ghost\" href=\"https:\/\/www.s-vt.net\/tr\/tesis-muhendisligi-proje-yonetimi\/#planung\">T\u00fcm hizmetler<\/a><\/div><\/div><h2>Di\u011fer hizmetler<\/h2><div class=\"svt-sgrid\"><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/tr\/tesis-muhendisligi-proje-yonetimi\/#planung\"><span>Planlama<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/tr\/tesis-muhendisligi-proje-yonetimi\/#basic-engineering\"><span>Temel m\u00fchendislik (Basic Engineering)<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/tr\/tesis-muhendisligi-proje-yonetimi\/#konstruktion\"><span>Tasar\u0131m deste\u011fi<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/tr\/tesis-muhendisligi-proje-yonetimi\/#beschaffung\"><span>Sat\u0131n alma deste\u011fi<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/tr\/tesis-muhendisligi-proje-yonetimi\/#lastenheft\"><span>Proses tesisleri i\u00e7in gereksinim \u015fartnamesi<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/tr\/tesis-muhendisligi-proje-yonetimi\/#terminplanung\"><span>Termin planlama ve kontrol\u00fc<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/tr\/tesis-muhendisligi-proje-yonetimi\/#bauueberwachung\"><span>\u015eantiye denetimi<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/tr\/tasarim-kalifikasyonu\/\"><span>DQ \u2013 Tasar\u0131m kalifikasyonu<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/tr\/kurulum-kalifikasyonu\/\"><span>IQ \u2013 Kurulum kalifikasyonu<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/tr\/performans-kalifikasyonu\/\"><span>PQ \u2013 Performans kalifikasyonu<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/tr\/proses-optimizasyonu\/\"><span>Proses optimizasyonu<\/span><i 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