{"id":200,"date":"2024-05-21T09:04:35","date_gmt":"2024-05-21T09:04:35","guid":{"rendered":"https:\/\/pfanstiehl.com\/?page_id=200"},"modified":"2024-07-08T05:09:06","modified_gmt":"2024-07-08T05:09:06","slug":"quality-systems","status":"publish","type":"page","link":"https:\/\/pfanstiehl.com\/en\/quality-systems\/","title":{"rendered":"Quality Systems"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"200\" class=\"elementor 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\">Pfanstiehl Quality<\/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 is globally recognized as a leader in manufacturing cGMP high-purity, low-endotoxin, low-metal injectable-grade excipients and biopharmaceutical components for various applications in bioprocessing, formulation, and specialty areas.<\/p><p>\u00a0<\/p><p>All Pfanstiehl&#8217;s products are manufactured in the USA at its Waukegan, Illinois facility, which adheres to ICH Q7 standards and is inspected and approved by the US FDA. The facility is conveniently located 35 minutes north of O\u2019Hare airport and the city of Chicago.<\/p>\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>Quality Systems:<\/h3><ul><li>Pfanstiehl, Inc. is registered with the United States Food and Drug Administration (FDA), registration number 1410747.\u00a0 Pfanstiehl is regularly inspected by the US FDA and other regulatory agencies and remains in good standing.<\/li><li>Pfanstiehl\u2019s Quality System is based on International Council for Harmonisation (ICH) Q7. Pfanstiehl applies this quality system to both Active Pharmaceutical Ingredient (API) and Biopharmaceutical Excipient manufacturing.<\/li><li>All products made by Pfanstiehl are considered manufactured under Good Manufacturing Practice (cGMP).<\/li><\/ul>\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 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.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>Customer Audits:<\/h3><ul><li>Pfanstiehl hosts 40 \u2013 50 audits annually<\/li><li>Customer interaction is a major driver of our quality improvement programs<\/li><li>To schedule an onsite audit of Pfanstiehl\u2019s facilities, please contact your business development representative or visit<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-486c4c7 elementor-position-right elementor-vertical-align-middle elementor-mobile-position-right elementor-vertical-align-middle elementor-hidden-desktop elementor-hidden-tablet elementor-hidden-mobile elementor-view-default elementor-widget elementor-widget-icon-box\" data-id=\"486c4c7\" data-element_type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/pfanstiehl.com\/wp-content\/plugins\/elementor\/assets\/css\/widget-icon-box.min.css\">\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<a href=\"#\" class=\"elementor-icon elementor-animation-\" tabindex=\"-1\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<a href=\"#\" >\n\t\t\t\t\t\t\tContact BD Team\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/span>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\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>Quality Control:<\/h3><ul><li>Pfanstiehl operates a near full-service Quality Control Laboratory at our facility staffed by highly qualified chemists.<\/li><li>Approximately 95% of Certificate of Analysis (CoA) testing is performed onsite.<\/li><li>Pfanstiehl continues to evaluate our products and expand our analytical capabilities, including the addition of bioanalytic panel to many of our products<\/li><\/ul>\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>Regulatory Control &amp; Support:<\/h3><ul><li>DMF Development and Maintenance<\/li><li>Management of Audits and Certifications<\/li><\/ul>\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>Quality Assurance<\/h3><ul><li>Change Control Process<\/li><li>Document Control Process<\/li><li>Global quality tracking system for deviation and corrective action preventive action (CAPA) management, laboratory investigations, complaints, change control, and supplier management.<\/li><\/ul>\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>Pfanstiehl Quality Pfanstiehl is globally recognized as a leader in manufacturing cGMP high-purity, low-endotoxin, low-metal injectable-grade excipients and biopharmaceutical components for various applications in bioprocessing, formulation, and specialty areas. \u00a0 All Pfanstiehl&#8217;s products are manufactured in the USA at its Waukegan, Illinois facility, which adheres to ICH Q7 standards and is inspected and approved by [&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-200","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Quality Systems - Pfanstiehl<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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