{"id":19021,"date":"2026-11-11T22:51:50","date_gmt":"2026-11-11T21:51:50","guid":{"rendered":"https:\/\/www.s-vt.net\/pq-performans-kalifikasyonu-performance-qualification\/"},"modified":"2026-11-11T23:21:05","modified_gmt":"2026-11-11T22:21:05","slug":"performans-kalifikasyonu","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/tr\/performans-kalifikasyonu\/","title":{"rendered":"PQ \u2013 Performans Kalifikasyonu (Performance 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\">Performans kalifikasyonu (PQ), tesislerin, sistemlerin ve ekipman\u0131n birbirine ba\u011fl\u0131 halde, onaylanm\u0131\u015f proses y\u00f6ntemi ve \u00fcr\u00fcn spesifikasyonuna dayanarak etkin ve tekrarlanabilir \u015fekilde \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131n belgelenmi\u015f do\u011frulamas\u0131d\u0131r.<\/p><div class=\"svt-ptiles\"><div class=\"svt-ptile\"><i class=\"fa fa-link\" aria-hidden=\"true\"><\/i><strong>Birbirine ba\u011fl\u0131 sistemler<\/strong><span>\u00d6rne\u011fin \u00fcretim tesisleri, dolum makineleri veya saf su sistemleri.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-flask\" aria-hidden=\"true\"><\/i><strong>Plasebo testi<\/strong><span>\u00dcr\u00fcn spesifikasyonu ve gereksinim \u015fartnamesine dayal\u0131 test.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><strong>Kalifikasyon raporu<\/strong><span>T\u00fcm kalifikasyon ad\u0131mlar\u0131na ili\u015fkin nihai rapor.<\/span><\/div><\/div><div class=\"svt-kgrid svt-kgrid-2\"><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 birbirine ba\u011fland\u0131klar\u0131 haliyle, onaylanm\u0131\u015f proses y\u00f6ntemi ve \u00fcr\u00fcn spesifikasyonuna dayanarak etkin ve tekrarlanabilir \u015fekilde \u00e7al\u0131\u015fabildi\u011finin belgelenmi\u015f do\u011frulamas\u0131.\u201d<\/p><\/div><div class=\"svt-kcard\"><i class=\"fa fa-clock-o\" aria-hidden=\"true\"><\/i><h3>PQ'nun zamanlamas\u0131<\/h3><p>PQ, \u015fu a\u015fama tamamland\u0131ktan sonra gelir: <a href=\"https:\/\/www.s-vt.net\/tr\/operasyonel-kalifikasyon\/\">OQ<\/a>. Her zaman proses veya temizlik validasyonundan \u00f6nce yap\u0131l\u0131r. Genellikle karma\u015f\u0131k, birbirine ba\u011fl\u0131 sistemleri kapsar \u2013 \u00f6rne\u011fin bir ila\u00e7 \u00fcretim tesisi, bir dolum makinesi veya <a href=\"https:\/\/www.s-vt.net\/tr\/demineralize-su-sistemleri\/\">saf su sistemleri<\/a>.<\/p><\/div><\/div><h2>PQ'nun test kriterleri<\/h2><p>Testlerin temeli: onaylanm\u0131\u015f \u00fcr\u00fcn spesifikasyonu ve <a href=\"https:\/\/www.s-vt.net\/tr\/tesis-muhendisligi-proje-yonetimi\/#lastenheft\">gereksinim \u015fartnamesi<\/a>. Bu temele dayanarak \u00f6rne\u011fin bir plasebo testi yap\u0131l\u0131r. Kriter olarak de\u011fer aral\u0131klar\u0131 ile \u00fcst ve alt s\u0131n\u0131rlar\u0131 olan performans parametreleri kullan\u0131l\u0131r, \u00f6rne\u011fin:<\/p><ul class=\"svt-tags\"><li>s\u0131cakl\u0131k s\u0131n\u0131rlar\u0131<\/li><li>devir aral\u0131klar\u0131<\/li><li>bas\u0131n\u00e7 aral\u0131klar\u0131<\/li><li>debiler<\/li><li>\u00fczerinde anla\u015f\u0131lan performans parametreleri ve \u00fcretim kapasitesi<\/li><li>adetler<\/li><li>do\u011fruluklar ve toleranslar<\/li><\/ul><h2>Kalifikasyonun tamamlanmas\u0131<\/h2><p>Kalifikasyon \u00e7al\u0131\u015fmalar\u0131n\u0131n sonunda kapsaml\u0131 bir rapor haz\u0131rlanmas\u0131 ola\u011fand\u0131r. Bu rapor, risk analizinden DQ, IQ ve OQ'ya ve PQ'ya kadar t\u00fcm ad\u0131mlar\u0131 belgeler.<\/p><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><a href=\"https:\/\/www.s-vt.net\/tr\/operasyonel-kalifikasyon\/\">OQ \u2013 Operasyonel kalifikasyon<\/a><\/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>PQ \u2013 Performans kalifikasyonu (bu sayfa)<\/strong><span class=\"svt-step-tx\">\u0130\u015fletmede gereken performans\u0131n kan\u0131t\u0131.<\/span><\/li><\/ol><p>Biz <strong>SEEFRIED Verfahrenstechnik GmbH<\/strong> olarak, performans kalifikasyonunun dok\u00fcmantasyonunda ve kontrol\u00fcnde \u2013 talep \u00fczerine di\u011fer t\u00fcm kalifikasyon ad\u0131mlar\u0131nda da \u2013 size destek veriyoruz.<\/p><h2>Performans kalifikasyonu (PQ) hakk\u0131nda s\u0131k sorulan sorular<\/h2>\n<h3>Performans kalifikasyonu (PQ) nedir?<\/h3>\n<p>PQ (Performance Qualification), birbirine ba\u011fl\u0131 tesislerin, sistemlerin ve ekipman\u0131n onaylanm\u0131\u015f proses y\u00f6ntemi ve \u00fcr\u00fcn spesifikasyonuna dayanarak etkin ve tekrarlanabilir \u015fekilde \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131n belgelenmi\u015f kan\u0131t\u0131d\u0131r (EU-GMP K\u0131lavuzu, Ek 15).<\/p>\n<h3>PQ ne zaman yap\u0131l\u0131r?<\/h3>\n<p>OQ ba\u015far\u0131yla tamamland\u0131ktan sonra ve her zaman proses veya temizlik validasyonundan \u00f6nce.<\/p>\n<h3>Hangi tesisler PQ gerektirir?<\/h3>\n<p>Genellikle ila\u00e7 \u00fcretim tesisleri, dolum makineleri veya saf su sistemleri gibi karma\u015f\u0131k, birbirine ba\u011fl\u0131 sistemler.<\/p>\n<h3>PQ'da hangi kriterler test edilir?<\/h3>\n<p>\u00dcst ve alt s\u0131n\u0131rlar\u0131 olan performans parametreleri, \u00f6rne\u011fin s\u0131cakl\u0131k, devir, bas\u0131n\u00e7, debi, \u00fczerinde anla\u015f\u0131lan \u00fcretim kapasitesi ile do\u011fruluklar ve toleranslar \u2013 \u00e7o\u011fu zaman bir plasebo testi kapsam\u0131nda.<\/p>\n<h3>Kalifikasyonun tamamlanmas\u0131 i\u00e7in neler gerekir?<\/h3>\n<p>Risk analizinden DQ, IQ ve OQ'ya ve PQ'ya kadar t\u00fcm ad\u0131mlar\u0131 kapsayan bir rapor.<\/p>\n<p><\/p><h2 class=\"svt-pcta-h\">Bizimle ileti\u015fime ge\u00e7in<\/h2><div class=\"svt-pcta svt-pcta-m\"><div class=\"svt-pcta-tx\">Performans kalifikasyonu 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:&#105;n&#102;&#111;&#64;&#115;-vt.&#110;et\">info&#64;s-&#118;t&#46;n&#101;t<\/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\/operasyonel-kalifikasyon\/\"><span>OQ \u2013 Operasyonel kalifikasyon<\/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 class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><\/div><script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Service\",\"name\":\"PQ \u2013 Performans kalifikasyonu\",\"description\":\"GMP tesisleri i\u00e7in performans kalifikasyonunun (PQ) dok\u00fcmantasyonu ve kontrol\u00fc ile nihai kalifikasyon raporunda destek.\",\"url\":\"https:\/\/www.s-vt.net\/tr\/performans-kalifikasyonu\/\",\"provider\":{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.s-vt.net\/#seefried\",\"name\":\"SEEFRIED Verfahrenstechnik GmbH\",\"url\":\"https:\/\/www.s-vt.net\/\",\"telephone\":\"+49 4203 789492\"},\"areaServed\":\"Worldwide\"},{\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Performans kalifikasyonu (PQ) 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