{"id":5136,"date":"2024-05-21T09:04:35","date_gmt":"2024-05-21T09:04:35","guid":{"rendered":"https:\/\/pfanstiehl.com\/systemes-de-qualite\/"},"modified":"2024-07-08T05:11:57","modified_gmt":"2024-07-08T05:11:57","slug":"systemes-de-qualite","status":"publish","type":"page","link":"https:\/\/pfanstiehl.com\/fr\/systemes-de-qualite\/","title":{"rendered":"Syst\u00e8mes de qualit\u00e9"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"5136\" class=\"elementor elementor-5136 elementor-200\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3577961 e-flex e-con-boxed e-con e-parent\" data-id=\"3577961\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-cfa3449 e-flex e-con-boxed e-con e-child\" data-id=\"cfa3449\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8d8a12e elementor-widget elementor-widget-heading\" data-id=\"8d8a12e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">Qualit\u00e9 Pfanstiehl<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-638d784 elementor-widget elementor-widget-text-editor\" data-id=\"638d784\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>Pfanstiehl est mondialement reconnu comme un leader dans la fabrication d\u2019excipients injectables de haute puret\u00e9, \u00e0 faible teneur en endotoxines et \u00e0 faible teneur en m\u00e9taux et de composants biopharmaceutiques pour diverses applications dans les domaines de la biotransformation, de la formulation et des domaines sp\u00e9cialis\u00e9s.<\/p>\n<\/p>\n<p>Tous les produits de Pfanstiehl sont fabriqu\u00e9s aux \u00c9tats-Unis dans son usine de Waukegan, dans l\u2019Illinois, qui adh\u00e8re aux normes ICH Q7 et est inspect\u00e9e et approuv\u00e9e par la FDA am\u00e9ricaine. L\u2019\u00e9tablissement est id\u00e9alement situ\u00e9 \u00e0 35 minutes au nord de l\u2019a\u00e9roport O\u2019Hare et de la ville de Chicago.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7f922d2 e-flex e-con-boxed e-con e-child\" data-id=\"7f922d2\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ba84bd4 elementor-widget elementor-widget-image\" data-id=\"ba84bd4\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"491\" src=\"https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/quality-systems-1024x629.png\" class=\"attachment-large size-large wp-image-2190\" alt=\"\" srcset=\"https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/quality-systems-1024x629.png 1024w, https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/quality-systems-300x184.png 300w, https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/quality-systems-768x472.png 768w, https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/quality-systems-600x368.png 600w, https:\/\/pfanstiehl.com\/wp-content\/uploads\/2024\/06\/quality-systems.png 1140w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-976e8c7 e-flex e-con-boxed e-con e-parent\" data-id=\"976e8c7\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b425caa padding-li-26 elementor-widget elementor-widget-text-editor\" data-id=\"b425caa\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h3>Syst\u00e8mes de qualit\u00e9 :<\/h3>\n<ul>\n<li>Pfanstiehl, Inc. est enregistr\u00e9e aupr\u00e8s de la Food and Drug Administration (FDA) des \u00c9tats-Unis, num\u00e9ro d\u2019enregistrement 1410747. Pfanstiehl est r\u00e9guli\u00e8rement inspect\u00e9 par la FDA am\u00e9ricaine et d\u2019autres organismes de r\u00e9glementation et reste en r\u00e8gle.<\/li>\n<li>Le syst\u00e8me de qualit\u00e9 de Pfanstiehl est bas\u00e9 sur la Q7 de l\u2019International Council for Harmonisation (ICH). Pfanstiehl applique ce syst\u00e8me de qualit\u00e9 \u00e0 la fois \u00e0 la fabrication d\u2019ingr\u00e9dients pharmaceutiques actifs (API) et d\u2019excipients biopharmaceutiques.<\/li>\n<li>Tous les produits fabriqu\u00e9s par Pfanstiehl sont consid\u00e9r\u00e9s comme fabriqu\u00e9s selon les bonnes pratiques de fabrication (BPF).<\/li>\n<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-36092f7 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"36092f7\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 *\/\n.elementor-widget-divider{--divider-border-style:none;--divider-border-width:1px;--divider-color:#0c0d0e;--divider-icon-size:20px;--divider-element-spacing:10px;--divider-pattern-height:24px;--divider-pattern-size:20px;--divider-pattern-url:none;--divider-pattern-repeat:repeat-x}.elementor-widget-divider .elementor-divider{display:flex}.elementor-widget-divider .elementor-divider__text{font-size:15px;line-height:1;max-width:95%}.elementor-widget-divider .elementor-divider__element{margin:0 var(--divider-element-spacing);flex-shrink:0}.elementor-widget-divider .elementor-icon{font-size:var(--divider-icon-size)}.elementor-widget-divider .elementor-divider-separator{display:flex;margin:0;direction:ltr}.elementor-widget-divider--view-line_icon .elementor-divider-separator,.elementor-widget-divider--view-line_text .elementor-divider-separator{align-items:center}.elementor-widget-divider--view-line_icon .elementor-divider-separator:after,.elementor-widget-divider--view-line_icon 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var(--divider-color)}.elementor-widget-divider--separator-type-pattern{--divider-border-style:none}.elementor-widget-divider--separator-type-pattern.elementor-widget-divider--view-line .elementor-divider-separator,.elementor-widget-divider--separator-type-pattern:not(.elementor-widget-divider--view-line) .elementor-divider-separator:after,.elementor-widget-divider--separator-type-pattern:not(.elementor-widget-divider--view-line) .elementor-divider-separator:before,.elementor-widget-divider--separator-type-pattern:not([class*=elementor-widget-divider--view]) .elementor-divider-separator{width:100%;min-height:var(--divider-pattern-height);-webkit-mask-size:var(--divider-pattern-size) 100%;mask-size:var(--divider-pattern-size) 100%;-webkit-mask-repeat:var(--divider-pattern-repeat);mask-repeat:var(--divider-pattern-repeat);background-color:var(--divider-color);-webkit-mask-image:var(--divider-pattern-url);mask-image:var(--divider-pattern-url)}.elementor-widget-divider--no-spacing{--divider-pattern-size:auto}.elementor-widget-divider--bg-round{--divider-pattern-repeat:round}.rtl .elementor-widget-divider .elementor-divider__text{direction:rtl}.e-con-inner>.elementor-widget-divider,.e-con>.elementor-widget-divider{width:var(--container-widget-width,100%);--flex-grow:var(--container-widget-flex-grow)}<\/style>\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3543bca e-flex e-con-boxed e-con e-parent\" data-id=\"3543bca\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1d4bbf2 padding-li-0 elementor-widget elementor-widget-text-editor\" data-id=\"1d4bbf2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h3>Audits clients :<\/h3>\n<ul>\n<li>Pfanstiehl organise 40 \u00e0 50 audits par an<\/li>\n<li>L\u2019interaction avec les clients est un moteur majeur de nos programmes d\u2019am\u00e9lioration de la qualit\u00e9<\/li>\n<li>Pour planifier un audit sur place des installations de Pfanstiehl, veuillez contacter votre repr\u00e9sentant du d\u00e9veloppement commercial ou visiter<\/li>\n<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-60a2f35 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"60a2f35\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-437bc32 e-flex e-con-boxed e-con e-parent\" data-id=\"437bc32\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-72fdb22 padding-li-0 elementor-widget elementor-widget-text-editor\" data-id=\"72fdb22\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h3>Contr\u00f4le qualit\u00e9:<\/h3>\n<ul>\n<li>Pfanstiehl exploite un laboratoire de contr\u00f4le de la qualit\u00e9 \u00e0 service quasi complet dans nos installations, dot\u00e9 de chimistes hautement qualifi\u00e9s.<\/li>\n<li>Environ 95 % des tests de certificat d\u2019analyse (CoA) sont effectu\u00e9s sur site.<\/li>\n<li>Pfanstiehl continue d\u2019\u00e9valuer nos produits et d\u2019\u00e9tendre nos capacit\u00e9s analytiques, y compris l\u2019ajout d\u2019un panel bioanalytique \u00e0 bon nombre de nos produits<\/li>\n<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-16a5ec1 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"16a5ec1\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b90724e e-flex e-con-boxed e-con e-parent\" data-id=\"b90724e\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-42dc2e5 padding-li-0 elementor-widget elementor-widget-text-editor\" data-id=\"42dc2e5\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h3>Contr\u00f4le et soutien r\u00e9glementaires :<\/h3>\n<ul>\n<li>D\u00e9veloppement et maintenance DMF<\/li>\n<li>Gestion des audits et des certifications<\/li>\n<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-960406d elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"960406d\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3128531 e-flex e-con-boxed e-con e-parent\" data-id=\"3128531\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e12e463 padding-li-0 elementor-widget elementor-widget-text-editor\" data-id=\"e12e463\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h3>Assurance qualit\u00e9<\/h3>\n<ul>\n<li>Processus de contr\u00f4le des modifications<\/li>\n<li>Processus de contr\u00f4le des documents<\/li>\n<li>Syst\u00e8me mondial de suivi de la qualit\u00e9 pour la gestion des \u00e9carts et des actions correctives (CAPA), les enqu\u00eates en laboratoire, les plaintes, le contr\u00f4le des changements et la gestion des fournisseurs.<\/li>\n<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Qualit\u00e9 Pfanstiehl Pfanstiehl est mondialement reconnu comme un leader dans la fabrication d\u2019excipients injectables de haute puret\u00e9, \u00e0 faible teneur en endotoxines et \u00e0 faible teneur en m\u00e9taux et de composants biopharmaceutiques pour diverses applications dans les domaines de la biotransformation, de la formulation et des domaines sp\u00e9cialis\u00e9s. Tous les produits de Pfanstiehl sont fabriqu\u00e9s [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"class_list":["post-5136","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Syst\u00e8mes de qualit\u00e9 - Pfanstiehl<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pfanstiehl.com\/fr\/systemes-de-qualite\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Syst\u00e8mes de qualit\u00e9 - Pfanstiehl\" \/>\n<meta property=\"og:description\" content=\"Qualit\u00e9 Pfanstiehl Pfanstiehl est mondialement reconnu comme un leader dans la fabrication d\u2019excipients injectables de haute puret\u00e9, \u00e0 faible teneur en endotoxines et \u00e0 faible teneur en m\u00e9taux et de composants biopharmaceutiques pour diverses applications dans les domaines de la biotransformation, de la formulation et des domaines sp\u00e9cialis\u00e9s. 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