{"id":862,"date":"2017-07-11T12:55:45","date_gmt":"2017-07-11T10:55:45","guid":{"rendered":"https:\/\/pharmpur.de\/qualitaet\/"},"modified":"2020-05-01T17:29:25","modified_gmt":"2020-05-01T15:29:25","slug":"qualitaet","status":"publish","type":"page","link":"https:\/\/pharmpur.de\/en\/qualitaet\/","title":{"rendered":"Quality"},"content":{"rendered":"<p>[vc_row][vc_column][rev_slider_vc alias=\u201dqualitaet_slider\u201d rev_slider_bg=\u201dLight\u201d][\/vc_column][\/vc_row][vc_row][vc_column width=\u201d1\/4\u2033][\/vc_column][vc_column width=\u201d1\/2\u2033][vc_column_text]<\/p>\n<h2 id=\"qualitaetsmanagement\" class=\"offset\">Quality Management<\/h2>\n<p>The quality management system of Pharmpur is process-oriented and is based on the standards ISO 9000 and ISO 13485. Today it comprises all elements necessary to produce medicinal and medical products. By incor\u00adpo\u00adrating business-management elements, energy management, environ\u00admental and risk management, it fulfills an important control function for the entire organi\u00adsation. The system\u2019s efficiency is monitored by frequent inspec\u00adtions by numerous national and foreign regulatory authorities.[\/vc_column_text][\/vc_column][vc_column width=\u201d1\/4\u2033][\/vc_column][\/vc_row][vc_row][vc_column width=\u201d1\/4\u2033][\/vc_column][vc_column width=\u201d1\/2\u2033][vc_column_text]<\/p>\n<h3 id=\"qualitaetspolitik\" class=\"offset\">Quality Policy<\/h3>\n<p>Our department of quality control realises the overall potential of our company in order to produce products with the highest possible degree of safety and conformity while conti\u00adnuously observing market condi\u00adtions; at the same time, the management follows ethical principles for dealing with all stake\u00adholders. The entire Pharmpur team is committed to the high ethical standards that charac\u00adterise the production of medicinal and medical products.[\/vc_column_text][\/vc_column][vc_column width=\u201d1\/4\u2033][\/vc_column][\/vc_row][vc_row full_width=\u201dstretch_row_content_no_spaces\u201d el_class=\u201dimageRow\u201d css=\u201d.vc_custom_1503589868657{background-image: url(https:\/\/pharmpur.de\/wp-content\/uploads\/2017\/07\/pharm_Qualitaet_sterilisation_50.jpg?id=759) !important;}\u201d][vc_column][\/vc_column][\/vc_row][vc_row full_width=\u201dstretch_row\u201d equal_height=\u201dyes\u201d content_placement=\u201dmiddle\u201d css=\u201d.vc_custom_1501839963876{background-color: #ededee !important;}\u201d el_class=\u201dtableRow\u201d][vc_column width=\u201d1\/4\u2033][\/vc_column][vc_column width=\u201d1\/2\u2033][vc_column_text]<\/p>\n<h3 id=\"wichtigeStandards\" class=\"offset\">Major standards<\/h3>\n<p>[\/vc_column_text][vc_column_text]<\/p>\n<table>\n<tbody>\n<tr>\n<td>Aseptic working<\/td>\n<td>EN ISO&nbsp;13408<\/td>\n<\/tr>\n<tr>\n<td>Biocom\u00adpa\u00adti\u00adbility<\/td>\n<td>EN ISO&nbsp;10993<\/td>\n<\/tr>\n<tr>\n<td>Clean rooms<\/td>\n<td>EN ISO&nbsp;14644<\/td>\n<\/tr>\n<tr>\n<td>Steri\u00adli\u00adsation<\/td>\n<td>EN ISO&nbsp;17664<\/td>\n<\/tr>\n<tr>\n<td>Medical Products<\/td>\n<td>EN ISO&nbsp;13485<\/td>\n<\/tr>\n<tr>\n<td>ICH Guide\u00adlines<\/td>\n<td>Q1 \u2013&nbsp;Q12<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>[\/vc_column_text][\/vc_column][vc_column width=\u201d1\/4\u2033][\/vc_column][\/vc_row][vc_row][vc_column width=\u201d1\/4\u2033][\/vc_column][vc_column width=\u201d1\/2\u2033][vc_column_text]<\/p>\n<h3>Elements of quality policy<\/h3>\n<p>[\/vc_column_text][\/vc_column][vc_column width=\u201d1\/4\u2033][\/vc_column][\/vc_row][vc_row full_width=\u201dstretch_row\u201d equal_height=\u201dyes\u201d css=\u201d.vc_custom_1502901674191{background-image: url(https:\/\/pharmpur.de\/wp-content\/uploads\/2017\/07\/Qualitaet_3131_BesprechungManagement38.jpg?id=519) !important;}\u201d el_class=\u201dinfoboxRow oneLine\u201d][vc_column width=\u201d1\/3\u2033 css=\u201d.vc_custom_1499782768924{background-color: rgba(255,255,255,0.9) !important;*background-color: rgb(255,255,255) !important;border-radius: 5px !important;}\u201d][vc_column_text]<\/p>\n<h3>Staff<\/h3>\n<p>[\/vc_column_text][vc_empty_space height=\u201d56px\u201d][vc_column_text]<\/p>\n<ul>\n<li>high training standards<\/li>\n<li>deep scien\u00adtific-technical understanding<\/li>\n<li>conti\u00adnuous GMP training<\/li>\n<li>strict hygiene<\/li>\n<li>health care<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][vc_column width=\u201d1\/3\u2033 css=\u201d.vc_custom_1499782783251{background-color: rgba(255,255,255,0.9) !important;*background-color: rgb(255,255,255) !important;border-radius: 5px !important;}\u201d][vc_column_text]<\/p>\n<h3>Processes<\/h3>\n<p>[\/vc_column_text][vc_empty_space height=\u201d56px\u201d][vc_column_text]<\/p>\n<ul>\n<li>efficiency verifi\u00adcation<\/li>\n<li>valida\u00adtions<\/li>\n<li>risk management<\/li>\n<li>dense network of in-process controls<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][vc_column width=\u201d1\/3\u2033 css=\u201d.vc_custom_1499782796870{background-color: rgba(255,255,255,0.9) !important;*background-color: rgb(255,255,255) !important;border-radius: 5px !important;}\u201d][vc_column_text]<\/p>\n<h3>Resources<\/h3>\n<p>[\/vc_column_text][vc_empty_space height=\u201d56px\u201d][vc_column_text]<\/p>\n<ul>\n<li>prudent use of raw materials and energy<\/li>\n<li>environ\u00admental protection<\/li>\n<li>control of emissions and pollution<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=\u201d1\/4\u2033][\/vc_column][vc_column width=\u201d1\/2\u2033][vc_column_text]<\/p>\n<h3 id=\"site_master_file\" class=\"offset\">Site Master File<\/h3>\n<p>[\/vc_column_text][vc_column_text]The Site Master File of Pharmpur GmbH is struc\u00adtured in accordance with the EU GMP Guideline part III and PIC\/S PE 008-4. Learn more?[\/vc_column_text][vc_column_text]<\/p>\n<p style=\"text-align: center;\"><a style=\"text-align: center;\" href=\"https:\/\/pharmpur.de\/en\/kontakt\/\"><button>Contact<\/button><\/a><\/p>\n<p>[\/vc_column_text][\/vc_column][vc_column width=\u201d1\/4\u2033][\/vc_column][\/vc_row][vc_row full_width=\u201dstretch_row\u201d equal_height=\u201dyes\u201d content_placement=\u201dmiddle\u201d][vc_column width=\u201d1\/4\u2033][\/vc_column][vc_column width=\u201d1\/2\u2033][vc_column_text css=\u201d.vc_custom_1502442161129{margin-bottom: 0px !important;}\u201d]<\/p>\n<h3 id=\"zertifikate\" class=\"offset\">Certi\u00adfi\u00adcates<\/h3>\n<p>[\/vc_column_text][vc_row_inner][vc_column_inner width=\u201d1\/2\u2033][vc_column_text]<\/p>\n<h5 style=\"text-align: left;\">Medical products<\/h5>\n<ul>\n<li>Notified body DQS Medizin\u00adprodukte GmbH <span class=\"s1\"><img loading=\"lazy\" class=\"alignnone wp-image-777\" src=\"https:\/\/pharmpur.de\/wp-content\/uploads\/2017\/07\/CE_Zeichen_klein.png\" alt width=\"18\" height=\"12\"><\/span> 0297<\/li>\n<li>EN ISO 13485:2012 + AC:&nbsp;2012<\/li>\n<li>Council Directive 93\/42\/EWG<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=\u201d1\/2\u2033][vc_column_text]<\/p>\n<h5 style=\"text-align: left;\">Medicinal Products<\/h5>\n<ul>\n<li>\n<p class=\"p1\"><span class=\"s1\">Super\u00advisory authority government of Upper Bavaria&nbsp;<\/span><\/p>\n<\/li>\n<li>DE_BY_04_MA_2017_0051\/ROB-53.2-2677.Ph_2_245<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=\u201d1\/4\u2033][\/vc_column][\/vc_row][vc_row full_width=\u201dstretch_row\u201d equal_height=\u201dyes\u201d content_placement=\u201dmiddle\u201d css=\u201d.vc_custom_1502723587418{background-color: #99c5e9 !important;}\u201d el_class=\u201dbuttonRow\u201d][vc_column width=\u201d1\/2\u2033][vc_column_text]Are you interested in colla\u00adbo\u00adrating with us and do you need current certificates?[\/vc_column_text][\/vc_column][vc_column width=\u201d1\/2\u2033][vc_column_text]<\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/pharmpur.de\/en\/kontakt\/\"><button>Contact<\/button><\/a><\/p>\n<p>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][rev_slider_vc alias=\u201dqualitaet_slider\u201d rev_slider_bg=\u201dLight\u201d][\/vc_column][\/vc_row][vc_row][vc_column width=\u201d1\/4\u2033][\/vc_column][vc_column width=\u201d1\/2\u2033][vc_column_text] Quality Management The quality management system of Pharmpur is process-oriented and is based on the standards ISO 9000 and ISO 13485. Today it comprises all elements necessary to produce medicinal and medical products. By incor\u00adpo\u00adrating business-management elements, energy management, environ\u00admental and risk management, it fulfills an important control function for&nbsp;\u2026<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-home.php","meta":{"wp_typography_post_enhancements_disabled":false},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v15.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Quality | Pharmpur Gmbh<\/title>\n<meta name=\"description\" content=\"Pharmpur ist ein unabh\u00e4ngiges Familienunternehmen und bietet die Herstellung von fl\u00fcssigen, sterilen Arzneimitteln und Medizinprodukten an.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharmpur.de\/en\/qualitaet\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Quality | Pharmpur Gmbh\" \/>\n<meta property=\"og:description\" content=\"Pharmpur ist ein unabh\u00e4ngiges Familienunternehmen und bietet die Herstellung von fl\u00fcssigen, sterilen Arzneimitteln und Medizinprodukten an.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pharmpur.de\/en\/qualitaet\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharmpur Gmbh\" \/>\n<meta property=\"article:modified_time\" content=\"2020-05-01T15:29:25+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/pharmpur.de\/wp-content\/uploads\/2017\/07\/CE_Zeichen_klein.png\" \/>\n<meta name=\"twitter:card\" content=\"summary\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\">\n\t<meta name=\"twitter:data1\" content=\"4 minutes\">\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebSite\",\"@id\":\"https:\/\/pharmpur.de\/#website\",\"url\":\"https:\/\/pharmpur.de\/\",\"name\":\"Pharmpur Gmbh\",\"description\":\"Arzneimittel und Medizinprodukte\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":\"https:\/\/pharmpur.de\/?s={search_term_string}\",\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"ImageObject\",\"@id\":\"https:\/\/pharmpur.de\/en\/qualitaet\/#primaryimage\",\"inLanguage\":\"en-US\",\"url\":\"https:\/\/pharmpur.de\/wp-content\/uploads\/2017\/07\/CE_Zeichen_klein.png\",\"width\":26,\"height\":18},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/pharmpur.de\/en\/qualitaet\/#webpage\",\"url\":\"https:\/\/pharmpur.de\/en\/qualitaet\/\",\"name\":\"Quality | Pharmpur Gmbh\",\"isPartOf\":{\"@id\":\"https:\/\/pharmpur.de\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/pharmpur.de\/en\/qualitaet\/#primaryimage\"},\"datePublished\":\"2017-07-11T10:55:45+00:00\",\"dateModified\":\"2020-05-01T15:29:25+00:00\",\"description\":\"Pharmpur ist ein unabh\\u00e4ngiges Familienunternehmen und bietet die Herstellung von fl\\u00fcssigen, sterilen Arzneimitteln und Medizinprodukten an.\",\"breadcrumb\":{\"@id\":\"https:\/\/pharmpur.de\/en\/qualitaet\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/pharmpur.de\/en\/qualitaet\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/pharmpur.de\/en\/qualitaet\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"item\":{\"@type\":\"WebPage\",\"@id\":\"https:\/\/pharmpur.de\/en\/\",\"url\":\"https:\/\/pharmpur.de\/en\/\",\"name\":\"Startseite\"}},{\"@type\":\"ListItem\",\"position\":2,\"item\":{\"@type\":\"WebPage\",\"@id\":\"https:\/\/pharmpur.de\/en\/qualitaet\/\",\"url\":\"https:\/\/pharmpur.de\/en\/qualitaet\/\",\"name\":\"Quality\"}}]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","_links":{"self":[{"href":"https:\/\/pharmpur.de\/en\/wp-json\/wp\/v2\/pages\/862"}],"collection":[{"href":"https:\/\/pharmpur.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pharmpur.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pharmpur.de\/en\/wp-json\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmpur.de\/en\/wp-json\/wp\/v2\/comments?post=862"}],"version-history":[{"count":8,"href":"https:\/\/pharmpur.de\/en\/wp-json\/wp\/v2\/pages\/862\/revisions"}],"predecessor-version":[{"id":1389,"href":"https:\/\/pharmpur.de\/en\/wp-json\/wp\/v2\/pages\/862\/revisions\/1389"}],"wp:attachment":[{"href":"https:\/\/pharmpur.de\/en\/wp-json\/wp\/v2\/media?parent=862"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}