{"id":5110,"date":"2024-05-21T09:04:35","date_gmt":"2024-05-21T09:04:35","guid":{"rendered":"https:\/\/pfanstiehl.com\/sistemas-de-calidad\/"},"modified":"2024-07-08T05:13:51","modified_gmt":"2024-07-08T05:13:51","slug":"sistemas-de-calidad","status":"publish","type":"page","link":"https:\/\/pfanstiehl.com\/es\/sistemas-de-calidad\/","title":{"rendered":"Sistemas de Calidad"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"5110\" class=\"elementor elementor-5110 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\">Calidad 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 es reconocido mundialmente como l\u00edder en la fabricaci\u00f3n de excipientes y componentes biofarmac\u00e9uticos de alta pureza, baja endotoxina y bajo contenido de metales para diversas aplicaciones en bioprocesamiento, formulaci\u00f3n y \u00e1reas especializadas.<\/p>\n<\/p>\n<p>Todos los productos de Pfanstiehl se fabrican en los EE. UU. en sus instalaciones de Waukegan, Illinois, que se adhieren a los est\u00e1ndares ICH Q7 y son inspeccionados y aprobados por la FDA de los EE. UU. La instalaci\u00f3n est\u00e1 convenientemente ubicada a 35 minutos al norte del aeropuerto O&#8217;Hare y de la ciudad 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>Sistemas de Calidad:<\/h3>\n<ul>\n<li>Pfanstiehl, Inc. est\u00e1 registrada en la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA), n\u00famero de registro 1410747. Pfanstiehl es inspeccionado regularmente por la FDA de EE. UU. y otras agencias reguladoras y se mantiene en buen estado.<\/li>\n<li>El Sistema de Calidad de Pfanstiehl se basa en el Consejo Internacional de Armonizaci\u00f3n (ICH) Q7. Pfanstiehl aplica este sistema de calidad tanto a la fabricaci\u00f3n de ingredientes farmac\u00e9uticos activos (API) como a la fabricaci\u00f3n de excipientes biofarmac\u00e9uticos.<\/li>\n<li>Todos los productos fabricados por Pfanstiehl se consideran fabricados bajo las Buenas Pr\u00e1cticas de Fabricaci\u00f3n (cGMP).<\/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 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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>Auditor\u00edas de clientes:<\/h3>\n<ul>\n<li>Pfanstiehl realiza entre 40 y 50 auditor\u00edas al a\u00f1o<\/li>\n<li>La interacci\u00f3n con el cliente es uno de los principales impulsores de nuestros programas de mejora de la calidad<\/li>\n<li>Para programar una auditor\u00eda in situ de las instalaciones de Pfanstiehl, p\u00f3ngase en contacto con su representante de desarrollo comercial o visite<\/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>Control de calidad:<\/h3>\n<ul>\n<li>Pfanstiehl opera un laboratorio de control de calidad de servicio casi completo en nuestras instalaciones, atendido por qu\u00edmicos altamente calificados.<\/li>\n<li>Aproximadamente el 95% de las pruebas de Certificado de An\u00e1lisis (CoA) se realizan in situ.<\/li>\n<li>Pfanstiehl contin\u00faa evaluando nuestros productos y ampliando nuestras capacidades anal\u00edticas, incluida la adici\u00f3n de paneles bioanal\u00edticos a muchos de nuestros productos<\/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>Control y Soporte Regulatorio:<\/h3>\n<ul>\n<li>Desarrollo y mantenimiento de DMF<\/li>\n<li>Gesti\u00f3n de Auditor\u00edas y Certificaciones<\/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>Garant\u00eda de calidad<\/h3>\n<ul>\n<li>Proceso de control de cambios<\/li>\n<li>Proceso de Control de Documentos<\/li>\n<li>Sistema global de seguimiento de calidad para la gesti\u00f3n de desviaciones y acciones correctivas preventivas (CAPA), investigaciones de laboratorio, quejas, control de cambios y gesti\u00f3n de proveedores.<\/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>Calidad Pfanstiehl Pfanstiehl es reconocido mundialmente como l\u00edder en la fabricaci\u00f3n de excipientes y componentes biofarmac\u00e9uticos de alta pureza, baja endotoxina y bajo contenido de metales para diversas aplicaciones en bioprocesamiento, formulaci\u00f3n y \u00e1reas especializadas. Todos los productos de Pfanstiehl se fabrican en los EE. UU. en sus instalaciones de Waukegan, Illinois, que se adhieren [&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-5110","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>Sistemas de Calidad - 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\/es\/sistemas-de-calidad\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sistemas de Calidad - Pfanstiehl\" \/>\n<meta property=\"og:description\" content=\"Calidad Pfanstiehl Pfanstiehl es reconocido mundialmente como l\u00edder en la fabricaci\u00f3n de excipientes y componentes biofarmac\u00e9uticos de alta pureza, baja endotoxina y bajo contenido de metales para diversas aplicaciones en bioprocesamiento, formulaci\u00f3n y \u00e1reas especializadas. 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