{"id":761,"date":"2021-05-21T17:10:12","date_gmt":"2021-05-21T17:10:12","guid":{"rendered":"https:\/\/www.biochem.de\/?page_id=761"},"modified":"2022-11-08T10:30:08","modified_gmt":"2022-11-08T10:30:08","slug":"quality-assurance","status":"publish","type":"page","link":"https:\/\/www.biochem.de\/en\/quality-assurance\/","title":{"rendered":"Quality Assurance"},"content":{"rendered":"\n<div class=\"block__intro mb-6 mb-md-7 \" id=\"block_62fdcf66a1f73\">\n    <div class=\"container-right nested-container\">\n        <div class=\"row\">\n            <div class=\"block__intro__column col-12 col-lg-7 col-xxxl-6 order-2 order-lg-1 d-flex flex-column justify-content-center mt-0 mt-lg-5\">\n                                    <div class=\"block__intro__logo mb-5 logo\">\n                        <img decoding=\"async\" class=\"img-fluid\" src=\"https:\/\/www.biochem.de\/app\/themes\/biochem\/assets\/images\/icon-logo.svg\" alt=\"BioChem Logo\">\n                    <\/div>\n                                <h2 class=\"heading-xxl\">Quality Assurance<\/h2>\n                <div class=\"body-lg block__intro__description\"><p>Quality is the basis of the daily work at <strong>BioChem Labor f\u00fcr biologische und chemische Analytik GmbH<\/strong>. Our quality is based on the many years of experience of our motivated staff and the will for continuous improvement of our processes while complying with all specifications in the GMP and GLP environment.<\/p>\n<p>Since 2022, in addition to the <strong>GMP certificate<\/strong>, BioChem also holds the <strong>manufacturer\u2019s authorisation<\/strong> for<\/p>\n<ul>\n<li><strong>human medicinal products<\/strong> and <strong>investigational medicinal products <\/strong>acc. to \u00a7 13 AMG as well as<\/li>\n<li><strong>veterinary medicinal products<\/strong> acc. to \u00a7 28 TAMG and (EU) 2019\/6.<\/li>\n<\/ul>\n<p>The manufacturer\u2019s authorisation 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<p>Here you can download our <a href=\"https:\/\/www.biochem.de\/en\/downloads\/#downloads\"><strong>certificates and authorisations<\/strong><\/a>.<\/p>\n<\/div>\n                            <\/div>\n            <div class=\"col-12 col-lg-5 offset-xxxl-1 col-xxxl-5 order-1 order-lg-2 pe-lg-0\">\n                <div class=\"block__intro__imagewrapper\">\n                    <img loading=\"lazy\" decoding=\"async\" width=\"675\" height=\"585\" src=\"https:\/\/www.biochem.de\/app\/uploads\/2022\/08\/Foto-Startseite-Qualitaet-675x585_1.jpg\" class=\"block__intro__image mb-6 mb-lg-0\" alt=\"\" srcset=\"https:\/\/www.biochem.de\/app\/uploads\/2022\/08\/Foto-Startseite-Qualitaet-675x585_1.jpg 675w, https:\/\/www.biochem.de\/app\/uploads\/2022\/08\/Foto-Startseite-Qualitaet-675x585_1-300x260.jpg 300w\" sizes=\"auto, (max-width: 675px) 100vw, 675px\" \/>                <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n\n\n<p>The tests carried out by BioChem within the meaning of <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u00a7 14 Para. 4 No. 3 of the German Medicines Act (AMG) are<\/li><\/ul>\n\n\n\n<p>have been reported to the competent supervisory authorities acc. to \u00a7 67 Para. 1 AMG.<\/p>\n\n\n\n<p>In addition, in order to maintain GMP and GLP compliance, we are subject to regular monitoring in acc. to<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>\u00a7 64 Para. 1 of the German Drug Law (AMG) by the authority for the supervision of medicines Baden-W\u00fcrttemberg and<\/li><li>Chemicals Act\/Directive 2004\/9\/EC by the Landesanstalt f\u00fcr Umwelt, Messungen und Naturschutz Baden-W\u00fcrttemberg (LUBW).<\/li><\/ul>\n\n\n\n<p>BioChem has been registered with the <strong>U.S. Food and Drug Administration (FDA)<\/strong> for many years under Facility Establishment Identifier (FEI) 3004058183, was successfully inspected repeatedly and is recognised as an independent, internationally accepted contract laboratory.<\/p>\n\n\n\n<p>When carrying out contract analysis, BioChem works in particular in acc. to \u00a7 14 and \u00a7 23 of the AMWHV, to the GMP principles and in acc. to<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>&#8220;EC Guide to Good Manufacturing Practice for Medicinal Products and Active Pharmaceutical Ingredients&#8221;,<\/li><li>&#8220;U.S. Code of Federal Regulation&#8221; (21 CFR Part 210\/211) and<\/li><li>Medical Devices Act (MPG)<\/li><\/ul>\n\n\n\n<p>BioChem also has the following authorisations and notified defined activities to the competent authorities:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>handling of <strong>narcotics <\/strong>acc. to \u00a7 3 Narcotics Act (BtMG)<\/li><li>handling of <strong>narcotic precursors<\/strong> acc. to G\u00dcG and (EG) 273\/2004 Art. 3 Para. 2 of category 1 substances<\/li><li>operation of a <strong>genetic engineering facility<\/strong> acc. to GenTG (Genetic Engineering Act) and GenTAufzV (Genetic Engineering Recording Ordinance) as well as GenTSV (Genetic Engineering Safety Ordinance) of safety level 1 and 2 acc. to GenTG (S2: project bound, according to agreement)<\/li><li>handling of <strong>pathogenic organisms <\/strong>acc. to \u00a7\u00a7 44 IfSG (Infection Protection Act)<\/li><li>handling of <strong>epizootic disease germs<\/strong> acc. to TierSeuchErV (Ordinance on Animal Pathogens)<\/li><\/ul>\n\n\n\n<p><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-white-color\">.<\/mark><\/p>\n\n\n\n<div class=\"block__contact-box mb-6 mb-md-7\" id=\"block_62fdcff3a1f74\">\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 persons 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>The tests carried out by BioChem within the meaning of \u00a7 14 Para. 4 No. 3 of the German Medicines [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-clean.php","meta":{"footnotes":""},"class_list":["post-761","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/pages\/761","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/comments?post=761"}],"version-history":[{"count":26,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/pages\/761\/revisions"}],"predecessor-version":[{"id":3489,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/pages\/761\/revisions\/3489"}],"wp:attachment":[{"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/media?parent=761"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}