{"id":18928,"date":"2026-11-11T22:47:54","date_gmt":"2026-11-11T21:47:54","guid":{"rendered":"https:\/\/www.s-vt.net\/pq-calificarea-performantei-performance-qualification\/"},"modified":"2026-11-11T23:18:22","modified_gmt":"2026-11-11T22:18:22","slug":"process-qualification","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/ro\/process-qualification\/","title":{"rendered":"PQ \u2013 calificarea performan\u021bei (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\">Calificarea performan\u021bei (PQ) este verificarea documentat\u0103 a faptului c\u0103 facilit\u0103\u021bile, instala\u021biile \u0219i echipamentele, conectate \u00eempreun\u0103, func\u021bioneaz\u0103 eficient \u0219i reproductibil pe baza metodei de proces \u0219i a specifica\u021biei de produs aprobate.<\/p><div class=\"svt-ptiles\"><div class=\"svt-ptile\"><i class=\"fa fa-link\" aria-hidden=\"true\"><\/i><strong>Sisteme interconectate<\/strong><span>De exemplu instala\u021bii de produc\u021bie, ma\u0219ini de umplere sau instala\u021bii de ap\u0103 ultrapur\u0103.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-flask\" aria-hidden=\"true\"><\/i><strong>Test placebo<\/strong><span>Testare pe baza specifica\u021biei de produs \u0219i a caietului de sarcini.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-file-text-o\" aria-hidden=\"true\"><\/i><strong>Raport de calificare<\/strong><span>Raport final privind toate etapele de calificare.<\/span><\/div><\/div><div class=\"svt-kgrid svt-kgrid-2\"><div class=\"svt-kcard\"><i class=\"fa fa-book\" aria-hidden=\"true\"><\/i><h3>Ghidul GMP al UE, Anexa 15<\/h3><p>\u201eVerificarea documentat\u0103 a faptului c\u0103 facilit\u0103\u021bile, sistemele \u0219i echipamentele, a\u0219a cum sunt conectate \u00eempreun\u0103, pot func\u021biona eficient \u0219i reproductibil pe baza metodei de proces \u0219i a specifica\u021biei de produs aprobate.\u201d<\/p><\/div><div class=\"svt-kcard\"><i class=\"fa fa-clock-o\" aria-hidden=\"true\"><\/i><h3>Momentul PQ<\/h3><p>PQ urmeaz\u0103 \u00eencheierii <a href=\"https:\/\/www.s-vt.net\/ro\/operational-qualification\/\">OQ<\/a>. Din punct de vedere temporal, are loc \u00eentotdeauna \u00eenaintea valid\u0103rii procesului, respectiv a cur\u0103\u021b\u0103rii. De regul\u0103, prive\u0219te sisteme complexe, interconectate \u2013 de exemplu o instala\u021bie de produc\u021bie farmaceutic\u0103, o ma\u0219in\u0103 de umplere sau <a href=\"https:\/\/www.s-vt.net\/ro\/di-water-plants\/\">instala\u021bii de ap\u0103 ultrapur\u0103<\/a>.<\/p><\/div><\/div><h2>Criteriile de testare ale PQ<\/h2><p>Baza testelor o constituie specifica\u021bia de produs aprobat\u0103 \u0219i <a href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#lastenheft\">caietul de sarcini<\/a>. Pe aceast\u0103 baz\u0103 se efectueaz\u0103, de exemplu, un test placebo. Drept criterii servesc parametri de performan\u021b\u0103 cu intervale de valori, precum \u0219i limite superioare \u0219i inferioare, de exemplu:<\/p><ul class=\"svt-tags\"><li>limite de temperatur\u0103<\/li><li>domenii de tura\u021bie<\/li><li>domenii de presiune<\/li><li>debite<\/li><li>parametri de performan\u021b\u0103 \u0219i randament conveni\u021bi<\/li><li>num\u0103r de buc\u0103\u021bi<\/li><li>precizii \u0219i toleran\u021be<\/li><\/ul><h2>Finalizarea calific\u0103rii<\/h2><p>La finalul lucr\u0103rilor de calificare se obi\u0219nuie\u0219te \u00eentocmirea unui raport cuprinz\u0103tor. Acesta documenteaz\u0103 toate etapele \u2013 de la analiza riscurilor, prin DQ, IQ \u0219i OQ, p\u00e2n\u0103 la PQ.<\/p><h2>Procesul de calificare pe scurt<\/h2><ol class=\"svt-steps\"><li><span class=\"svt-step-n\">1<\/span><strong>RA \u2013 analiza riscurilor<\/strong><span class=\"svt-step-tx\">Identificarea \u0219i evaluarea riscurilor \u00eenainte de stabilirea designului.<\/span><\/li><li><span class=\"svt-step-n\">2<\/span><strong><a href=\"https:\/\/www.s-vt.net\/ro\/design-qualification\/\">DQ \u2013 calificarea designului<\/a><\/strong><span class=\"svt-step-tx\">Dovada c\u0103 designul este adecvat utiliz\u0103rii prev\u0103zute.<\/span><\/li><li><span class=\"svt-step-n\">3<\/span><strong><a href=\"https:\/\/www.s-vt.net\/ro\/installation-qualification\/\">IQ \u2013 calificarea instal\u0103rii<\/a><\/strong><span class=\"svt-step-tx\">Verificarea instal\u0103rii \u00een raport cu documentele de comand\u0103.<\/span><\/li><li><span class=\"svt-step-n\">4<\/span><strong><a href=\"https:\/\/www.s-vt.net\/ro\/operational-qualification\/\">OQ \u2013 calificarea opera\u021bional\u0103<\/a><\/strong><span class=\"svt-step-tx\">Verificarea func\u021bion\u0103rii prev\u0103zute.<\/span><\/li><li><span class=\"svt-step-n\">5<\/span><strong>PQ \u2013 calificarea performan\u021bei (aceast\u0103 pagin\u0103)<\/strong><span class=\"svt-step-tx\">Dovada performan\u021bei cerute \u00een exploatare.<\/span><\/li><\/ol><p>Societatea <strong>SEEFRIED Verfahrenstechnik GmbH<\/strong> v\u0103 sprijin\u0103 la documentarea \u0219i verificarea calific\u0103rii performan\u021bei \u2013 \u0219i, la cerere, la toate celelalte etape de calificare.<\/p><h2>\u00centreb\u0103ri frecvente despre calificarea performan\u021bei (PQ)<\/h2>\n<h3>Ce este calificarea performan\u021bei (PQ)?<\/h3>\n<p>PQ (Performance Qualification) este dovada documentat\u0103 c\u0103 facilit\u0103\u021bile, instala\u021biile \u0219i echipamentele interconectate func\u021bioneaz\u0103 eficient \u0219i reproductibil pe baza metodei de proces \u0219i a specifica\u021biei de produs aprobate (Ghidul GMP al UE, Anexa 15).<\/p>\n<h3>C\u00e2nd se efectueaz\u0103 PQ?<\/h3>\n<p>Dup\u0103 \u00eencheierea cu succes a OQ \u0219i \u00eentotdeauna \u00eenaintea valid\u0103rii procesului, respectiv a cur\u0103\u021b\u0103rii.<\/p>\n<h3>Ce instala\u021bii necesit\u0103 PQ?<\/h3>\n<p>De regul\u0103, sistemele complexe, interconectate, precum instala\u021biile de produc\u021bie farmaceutic\u0103, ma\u0219inile de umplere sau instala\u021biile de ap\u0103 ultrapur\u0103.<\/p>\n<h3>Ce criterii se verific\u0103 \u00een cadrul PQ?<\/h3>\n<p>Parametri de performan\u021b\u0103 cu limite superioare \u0219i inferioare, de ex. temperatur\u0103, tura\u021bie, presiune, debit, randament convenit, precum \u0219i precizii \u0219i toleran\u021be \u2013 adesea \u00een cadrul unui test placebo.<\/p>\n<h3>Ce presupune finalizarea calific\u0103rii?<\/h3>\n<p>Un raport cuprinz\u0103tor privind toate etapele \u2013 de la analiza riscurilor, prin DQ, IQ \u0219i OQ, p\u00e2n\u0103 la PQ.<\/p>\n<p><\/p><h2 class=\"svt-pcta-h\">Contacta\u021bi-ne<\/h2><div class=\"svt-pcta svt-pcta-m\"><div class=\"svt-pcta-tx\">V\u0103 oferim cu pl\u0103cere consultan\u021b\u0103 privind calificarea performan\u021bei \u2013 telefonic la <a href=\"tel:+494203789492\">+49 4203 789492<\/a> sau prin e-mail la <a href=\"mailto:i&#110;fo&#64;s&#45;&#118;&#116;.&#110;&#101;&#116;\">inf&#111;&#64;&#115;&#45;v&#116;&#46;&#110;et<\/a>.<\/div><div class=\"svt-pcta-btns\"><a class=\"svt-btn svt-btn-primary\" href=\"https:\/\/www.s-vt.net\/ro\/contact\/?produkt=Verfahrenstechnische%20Beratung\">Trimite\u021bi solicitarea<\/a><a class=\"svt-btn svt-btn-ghost\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#planung\">Toate serviciile<\/a><\/div><\/div><h2>Alte servicii<\/h2><div class=\"svt-sgrid\"><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#planung\"><span>Proiectare<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#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\/ro\/plant-engineering-project-execution\/#konstruktion\"><span>Asisten\u021b\u0103 la proiectarea constructiv\u0103<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#beschaffung\"><span>Asisten\u021b\u0103 la achizi\u021bii<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#lastenheft\"><span>Caiet de sarcini pentru instala\u021bii de proces<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#terminplanung\"><span>Planificarea \u0219i controlul termenelor<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/plant-engineering-project-execution\/#bauueberwachung\"><span>Supravegherea execu\u021biei<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/design-qualification\/\"><span>DQ \u2013 calificarea designului<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/installation-qualification\/\"><span>IQ \u2013 calificarea instal\u0103rii<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/operational-qualification\/\"><span>OQ \u2013 calificarea opera\u021bional\u0103<\/span><i class=\"fa fa-angle-right\" aria-hidden=\"true\"><\/i><\/a><a class=\"svt-scard\" href=\"https:\/\/www.s-vt.net\/ro\/process-optimisation\/\"><span>Optimizarea proceselor<\/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 calificarea performan\u021bei\",\"description\":\"Sprijin la documentarea \u0219i verificarea calific\u0103rii performan\u021bei (PQ), precum \u0219i la raportul final de calificare pentru instala\u021bii GMP.\",\"url\":\"https:\/\/www.s-vt.net\/ro\/process-qualification\/\",\"provider\":{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.s-vt.net\/#seefried\",\"name\":\"SEEFRIED Verfahrenstechnik GmbH\",\"url\":\"https:\/\/www.s-vt.net\/\",\"telephone\":\"+49 4203 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