{"id":18582,"date":"2026-11-11T22:35:12","date_gmt":"2026-11-11T21:35:12","guid":{"rendered":"https:\/\/www.s-vt.net\/pq-qualification-de-performance\/"},"modified":"2026-11-11T23:08:49","modified_gmt":"2026-11-11T22:08:49","slug":"qualification-de-performance","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/fr\/qualification-de-performance\/","title":{"rendered":"PQ \u2013 Qualification de performance"},"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\">La qualification de performance (PQ) est la v\u00e9rification document\u00e9e que les installations, syst\u00e8mes et \u00e9quipements, agenc\u00e9s ensemble, fonctionnent de mani\u00e8re efficace et reproductible sur la base de la m\u00e9thode op\u00e9rationnelle approuv\u00e9e et de la sp\u00e9cification du produit.<\/p><div class=\"svt-ptiles\"><div class=\"svt-ptile\"><i class=\"fa fa-link\" aria-hidden=\"true\"><\/i><strong>Syst\u00e8mes interconnect\u00e9s<\/strong><span>Par exemple installations de production, remplisseuses ou installations d\u2019eau purifi\u00e9e.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-flask\" aria-hidden=\"true\"><\/i><strong>Test placebo<\/strong><span>Essai fond\u00e9 sur la sp\u00e9cification du produit et le cahier des charges.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><strong>Rapport de qualification<\/strong><span>Rapport final sur toutes les \u00e9tapes de la qualification.<\/span><\/div><\/div><div class=\"svt-kgrid svt-kgrid-2\"><div class=\"svt-kcard\"><i class=\"fa fa-book\" aria-hidden=\"true\"><\/i><h3>Guide GMP de l\u2019UE, annexe 15<\/h3><p>\u00ab&nbsp;V\u00e9rification document\u00e9e que les installations, syst\u00e8mes et \u00e9quipements, tels qu\u2019ils ont \u00e9t\u00e9 agenc\u00e9s ensemble, sont en mesure de fonctionner de mani\u00e8re efficace et reproductible, sur la base de la m\u00e9thode op\u00e9rationnelle approuv\u00e9e et de la sp\u00e9cification du produit.&nbsp;\u00bb<\/p><\/div><div class=\"svt-kcard\"><i class=\"fa fa-clock-o\" aria-hidden=\"true\"><\/i><h3>Moment de la PQ<\/h3><p>La PQ intervient apr\u00e8s l\u2019ach\u00e8vement de la phase <a href=\"https:\/\/www.s-vt.net\/fr\/qualification-operationnelle\/\">OQ<\/a>. Elle intervient toujours avant la validation du proc\u00e9d\u00e9 ou du nettoyage. Elle concerne g\u00e9n\u00e9ralement des syst\u00e8mes complexes et interconnect\u00e9s \u2013 par exemple une installation de production pharmaceutique, une remplisseuse ou des <a href=\"https:\/\/www.s-vt.net\/fr\/eau-demineralisee-boucles\/\">installations d\u2019eau purifi\u00e9e<\/a>.<\/p><\/div><\/div><h2>Crit\u00e8res d\u2019essai de la PQ<\/h2><p>Les essais reposent sur la sp\u00e9cification approuv\u00e9e du produit et sur le <a href=\"https:\/\/www.s-vt.net\/fr\/ingenierie-installations-gestion-projet\/#lastenheft\">cahier des charges<\/a>. Sur cette base, on r\u00e9alise par exemple un test placebo. Les crit\u00e8res sont des param\u00e8tres de performance avec des plages de valeurs ainsi que des limites sup\u00e9rieures et inf\u00e9rieures, par exemple&nbsp;:<\/p><ul class=\"svt-tags\"><li>limites de temp\u00e9rature<\/li><li>plages de vitesse de rotation<\/li><li>plages de pression<\/li><li>d\u00e9bits<\/li><li>param\u00e8tres de performance et rendement convenus<\/li><li>quantit\u00e9s produites<\/li><li>pr\u00e9cisions et tol\u00e9rances<\/li><\/ul><h2>Cl\u00f4ture de la qualification<\/h2><p>\u00c0 l\u2019issue des travaux de qualification, un rapport complet est d\u2019usage. Il documente toutes les \u00e9tapes \u2013 de l\u2019analyse de risques \u00e0 la DQ, l\u2019IQ et l\u2019OQ, jusqu\u2019\u00e0 la PQ.<\/p><h2>Le processus de qualification en bref<\/h2><ol class=\"svt-steps\"><li><span class=\"svt-step-n\">1<\/span><strong>RA \u2013 Analyse de risques<\/strong><span class=\"svt-step-tx\">Identifier et \u00e9valuer les risques avant que la conception ne soit fig\u00e9e.<\/span><\/li><li><span class=\"svt-step-n\">2<\/span><strong><a href=\"https:\/\/www.s-vt.net\/fr\/qualification-de-conception\/\">DQ \u2013 Qualification de conception<\/a><\/strong><span class=\"svt-step-tx\">Preuve que la conception convient \u00e0 l\u2019usage pr\u00e9vu.<\/span><\/li><li><span class=\"svt-step-n\">3<\/span><strong><a href=\"https:\/\/www.s-vt.net\/fr\/qualification-d-installation\/\">IQ \u2013 Qualification d\u2019installation<\/a><\/strong><span class=\"svt-step-tx\">V\u00e9rification de l\u2019installation par rapport aux documents de commande.<\/span><\/li><li><span class=\"svt-step-n\">4<\/span><strong><a href=\"https:\/\/www.s-vt.net\/fr\/qualification-operationnelle\/\">OQ \u2013 Qualification op\u00e9rationnelle<\/a><\/strong><span class=\"svt-step-tx\">V\u00e9rification du fonctionnement pr\u00e9vu.<\/span><\/li><li><span class=\"svt-step-n\">5<\/span><strong>PQ \u2013 Qualification de performance (cette page)<\/strong><span class=\"svt-step-tx\">Preuve de la performance requise en exploitation.<\/span><\/li><\/ol><p>La soci\u00e9t\u00e9 <strong>SEEFRIED Verfahrenstechnik GmbH<\/strong> vous accompagne dans la documentation et la v\u00e9rification de la qualification de performance \u2013 et, sur demande, dans toutes les autres \u00e9tapes de la qualification.<\/p><h2>Questions fr\u00e9quentes sur la qualification de performance (PQ)<\/h2>\n<h3>Qu\u2019est-ce que la qualification de performance (PQ)&nbsp;?<\/h3>\n<p>La PQ (Performance Qualification) est la preuve document\u00e9e que des installations, syst\u00e8mes et \u00e9quipements interconnect\u00e9s fonctionnent de mani\u00e8re efficace et reproductible sur la base de la m\u00e9thode op\u00e9rationnelle approuv\u00e9e et de la sp\u00e9cification du produit (guide GMP de l\u2019UE, annexe 15).<\/p>\n<h3>Quand la PQ est-elle r\u00e9alis\u00e9e&nbsp;?<\/h3>\n<p>Apr\u00e8s l\u2019ach\u00e8vement r\u00e9ussi de l\u2019OQ et toujours avant la validation du proc\u00e9d\u00e9 ou du nettoyage.<\/p>\n<h3>Quelles installations n\u00e9cessitent une PQ&nbsp;?<\/h3>\n<p>En r\u00e8gle g\u00e9n\u00e9rale, des syst\u00e8mes complexes et interconnect\u00e9s tels que les installations de production pharmaceutique, les remplisseuses ou les installations d\u2019eau purifi\u00e9e.<\/p>\n<h3>Quels crit\u00e8res sont v\u00e9rifi\u00e9s lors de la PQ&nbsp;?<\/h3>\n<p>Des param\u00e8tres de performance avec limites sup\u00e9rieures et inf\u00e9rieures, p. ex. temp\u00e9rature, vitesse de rotation, pression, d\u00e9bit, rendement convenu ainsi que pr\u00e9cisions et tol\u00e9rances \u2013 souvent dans le cadre d\u2019un test placebo.<\/p>\n<h3>Qu\u2019est-ce qui fait partie de la cl\u00f4ture de la qualification&nbsp;?<\/h3>\n<p>Un rapport complet sur toutes les \u00e9tapes \u2013 de l\u2019analyse de risques \u00e0 la DQ, l\u2019IQ et l\u2019OQ, jusqu\u2019\u00e0 la PQ.<\/p>\n<p><\/p><h2 class=\"svt-pcta-h\">Contactez-nous<\/h2><div class=\"svt-pcta svt-pcta-m\"><div class=\"svt-pcta-tx\">Nous vous conseillons volontiers sur la qualification de performance \u2013 par t\u00e9l\u00e9phone au <a href=\"tel:+494203789492\">+49 4203 789492<\/a> ou par e-mail \u00e0 <a href=\"mailto:inf&#111;&#64;&#115;&#45;vt.&#110;&#101;t\">&#105;&#110;&#102;o&#64;&#115;&#45;&#118;&#116;&#46;&#110;&#101;&#116;<\/a>.<\/div><div class=\"svt-pcta-btns\"><a class=\"svt-btn svt-btn-primary\" href=\"https:\/\/www.s-vt.net\/fr\/contact\/?produkt=Verfahrenstechnische%20Beratung\">Envoyer une demande<\/a><a class=\"svt-btn svt-btn-ghost\" href=\"https:\/\/www.s-vt.net\/fr\/ingenierie-installations-gestion-projet\/#planung\">Tous les services<\/a><\/div><\/div><h2>Autres services<\/h2><div class=\"svt-sgrid\"><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/fr\/ingenierie-installations-gestion-projet\/#planung\"><span>Planification<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/fr\/ingenierie-installations-gestion-projet\/#basic-engineering\"><span>Basic engineering<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/fr\/ingenierie-installations-gestion-projet\/#konstruktion\"><span>Assistance \u00e0 la conception<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/fr\/ingenierie-installations-gestion-projet\/#beschaffung\"><span>Assistance aux achats<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/fr\/ingenierie-installations-gestion-projet\/#lastenheft\"><span>Cahier des charges pour installations de process<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/fr\/ingenierie-installations-gestion-projet\/#terminplanung\"><span>Planification &amp; suivi des d\u00e9lais<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/fr\/ingenierie-installations-gestion-projet\/#bauueberwachung\"><span>Suivi de chantier<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/fr\/qualification-de-conception\/\"><span>DQ \u2013 Qualification de conception<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/fr\/qualification-d-installation\/\"><span>IQ \u2013 Qualification d\u2019installation<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/fr\/qualification-operationnelle\/\"><span>OQ \u2013 Qualification op\u00e9rationnelle<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/fr\/optimisation-des-procedes\/\"><span>Optimisation des proc\u00e9d\u00e9s<\/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 Qualification de performance\",\"description\":\"Accompagnement dans la documentation et la v\u00e9rification de la qualification de performance (PQ) ainsi que dans le rapport final de qualification pour installations 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