{"id":2853,"date":"2022-06-01T14:21:00","date_gmt":"2022-06-01T14:21:00","guid":{"rendered":"https:\/\/www.biochem.de\/news\/biochem-herstellungserlaubnis-und-qp-service\/"},"modified":"2022-10-19T11:28:40","modified_gmt":"2022-10-19T11:28:40","slug":"biochem-manufacturers-authorisation-qp-service","status":"publish","type":"post","link":"https:\/\/www.biochem.de\/en\/news\/biochem-manufacturers-authorisation-qp-service\/","title":{"rendered":"New at BioChem: Manufacturer\u2019s Authorisation and QP service"},"content":{"rendered":"\n<p>Following a successful inspection by the Regional Council (Regierungspr\u00e4sidium) of Tuebingen, Germany, <strong>BioChem Labor f\u00fcr biologische und chemische Analytik GmbH<\/strong> obtained, in addition to the GMP confirmation, the <strong>Manufacturer&#8217;s Authorisation<\/strong> for<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>human medicinal products<\/strong> and <strong>human investigational medicinal products<\/strong> acc. to \u00a7 13 AMG and<\/li><li><strong>veterinary medicinal products<\/strong> acc. to \u00a7 28 TAMG and (EU) 2019\/6<\/li><\/ul>\n\n\n\n<p>This refers to the microbiological, chemical\/physical and biological <strong>quality control<\/strong> for medicinal products, raw and starting materials, active pharmaceutical ingredients and packaging materials.<\/p>\n\n\n\n<p>All certificates are available for download in the Public Layout of the <a href=\"http:\/\/eudragmdp.ema.europa.eu\/inspections\/displayWelcome.do\" target=\"_blank\" rel=\"noreferrer noopener\">EudraGMDP database<\/a> and on our homepage in the <a href=\"\/?page_id=369\" target=\"_blank\" rel=\"noreferrer noopener\">downloads<\/a> section.<\/p>\n\n\n\n<p>BioChem is pleased to offer its clients now a variety of services through the own QP (Sachkundige Person\/Qualified Person acc. to \u00a7 15 AMG), Ms Clarissa Kohn. This new <strong>QP service<\/strong> optimally complements BioChem&#8217;s wide range of analyses:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Confirmation of quality control by QP<\/li><li>Storage of retention samples acc. to \u00a7 18 AMWHV and Annex 19 GMP guideline<\/li><li>Consulting of clients on obtaining their own manufacturer\u2019s authorisation<\/li><li>Further consulting services, e.g., on GMP topics and regulatory requirements on request<\/li><\/ul>\n\n\n\n<p>In our brochure \u201e<strong>Manufacturer\u2019s Authorisation and QP service<\/strong>\u201d, these services are summarised (<a rel=\"noreferrer noopener\" href=\"https:\/\/www.biochem.de\/wp-content\/uploads\/2022\/06\/2022-06_BioChem_Flyer_Herstellungserlaubnis_QP-Service.pdf\" target=\"_blank\">please click here for download<\/a>).<\/p>\n\n\n\n<div class=\"block__contact-box mb-0\" id=\"block_6343d8795b890\">\n    <div class=\"container\">\n        <div class=\"row\">\n            <div class=\"block__contact-box__inner col-12 col-md-10 offset-md-1 d-flex flex-column p-3 p-sm-6 shadow\">\n                                    <h2 class=\"order-2 heading-sm\">Contact the experts of our quality assurance department<\/h2>\n                                <div class=\"badge-orange order-1 mb-4\">Contact<\/div>\n                                    <div class=\"order-3 block__contact-box__description\"><p>The experts in our quality assurance department will be pleased to advise you and support you with your quality-related questions.<\/p>\n<p>Please use our contact form for your enquiry.<\/p>\n<\/div>\n                                <div class=\"block__contact-box__buttons order-4 mt-5 mt-xl-5\">\n                                                                        <a class=\"button md-button-fw order-4 text-center\" href=\"https:\/\/www.biochem.de\/en\/contact\/#quality-assurance-qp\">Contact person quality assurance | qualified person<\/a>\n                                                                                                                    <a class=\"button md-button-fw order-4 text-center\" href=\"https:\/\/www.biochem.de\/en\/contact\/\">Contact form<\/a>\n                                                            <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Following a successful inspection by the Regional Council (Regierungspr\u00e4sidium) of Tuebingen, Germany, BioChem Labor f\u00fcr biologische und chemische Analytik GmbH [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":2846,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-2853","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/posts\/2853","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/comments?post=2853"}],"version-history":[{"count":7,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/posts\/2853\/revisions"}],"predecessor-version":[{"id":3028,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/posts\/2853\/revisions\/3028"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/media\/2846"}],"wp:attachment":[{"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/media?parent=2853"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/categories?post=2853"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/tags?post=2853"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}