{"id":2670,"date":"2020-10-01T11:53:00","date_gmt":"2020-10-01T11:53:00","guid":{"rendered":"https:\/\/www.biochem.de\/news\/unabhaengige-qualitaetskontrolle-nach-gmp-standard-fuer-herstellende-apotheken\/"},"modified":"2022-10-06T07:58:13","modified_gmt":"2022-10-06T07:58:13","slug":"unabhaengige-qualitaetskontrolle-nach-gmp-standard-fuer-herstellende-apotheken","status":"publish","type":"post","link":"https:\/\/www.biochem.de\/en\/news\/unabhaengige-qualitaetskontrolle-nach-gmp-standard-fuer-herstellende-apotheken\/","title":{"rendered":"Independent quality control according to GMP standard for manufacturing companies"},"content":{"rendered":"\n<p>The guidelines for the sterile\/aseptic manufacture of medicinal products in clean rooms increasingly stipulate <strong>quality assurance and control measures<\/strong> (Annex 1 EU GMP Guidelines). As a <strong>GMP certified quality control laboratory<\/strong>, <strong>BioChem Labor f\u00fcr biologische und chemische Analytik GmbH<\/strong>, Karlsruhe, offers manufacturers a variety of analytical laboratory services for their product release.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p>These include in particular:<\/p>\n\n\n\n<p><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Validation and testing for sterility<\/strong><br>Test for sterility acc. to Ph. Eur. 2.6.1 and USP &lt;71&gt;, performed in an isolator<\/li><li><strong><strong>Validation and testing for<\/strong><\/strong> <strong>bacterial endotoxins<\/strong><br>LAL test acc. to Ph. Eur. 2.6.14\/5.1.10 and USP &lt;85&gt;<br>rFC test&nbsp;acc. to Ph. Eur. 2.6.32<\/li><li><strong><strong><strong>Validation and microbiological examination of of non-sterile products (raw material)<\/strong><\/strong><\/strong><br>Test acc. to&nbsp;Ph. Eur. 2.6.12\/2.6.13 and USP &lt;61&gt;\/&lt;62&gt;<\/li><li>Further <strong>tests acc. to pharmacopoeial methods<\/strong> as well as <strong>chemical analyses<\/strong>, e.g. to determine the identity and concentration of active substances<\/li><\/ul>\n\n\n\n<p>Als&nbsp;<strong>unabh\u00e4ngiges, GMP-zertifiziertes Qualit\u00e4tskontrolllabor&nbsp;<\/strong>liefern wir Ihnen schnelle und zuverl\u00e4ssige Ergebnisse. Somit k\u00f6nnen herstellende Betriebe die&nbsp;<strong>Sicherheit<\/strong>&nbsp;ihrer selbst hergestellten Arzneimittel gegen\u00fcber ihren Kunden und den Beh\u00f6rden jederzeit nachweisen. Zu unseren Kunden in diesem Bereich z\u00e4hlen u. a. Hersteller steriler\/aseptischer Parenteralia ebenso wie steriler und unsteriler Defekturarzneimittel von individuellen Apotheken bis hin zu internationalen Pharmaherstellern. Unsere Mitarbeitenden sind qualifiziert im&nbsp;<strong>Umgang mit hochwirksamen und toxischen Substanzen<\/strong>&nbsp;wie Zytostatika, BTMs, KMR-Substanzen, Hormone und Antibiotika.<\/p>\n\n\n\n<p>As an <strong>independent, GMP certified quality control laboratory<\/strong>, we provide you with fast and reliable results. Thus, manufacturers can prove the <strong>safety <\/strong>of their manufactured medicinal products to their customers and the authorities at any time. Our customers in this area include manufacturers of sterile\/aseptic parenterals as well as sterile and non-sterile pharmaceuticals from individual pharmacies to international pharmaceutical manufacturers. Our employees are qualified in <strong>handling highly effective and\/or toxic substances e.g. narcotics, cytostatic drugs, hormones, antibiotics and CMR substances <\/strong>(carcinogenic, mutagenic, reproductive toxicity).<\/p>\n\n\n\n<p><strong>Please contact us if you are interested<\/strong> in our analyses. The experts of our <strong>microbiological<\/strong> department will be pleased to provide you with further information.<\/p>\n\n\n\n<div class=\"block__contact-box mb-5\" id=\"block_633e7eaf71f0f\">\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 microbiological 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 microbiological department will be pleased to provide you with advice and support in planning and carrying out microbiological tests for your products or projects. We will be pleased to prepare an offer tailored to your current issues.<\/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\/#microbiology\">Contact person microbiological department<\/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 guidelines for the sterile\/aseptic manufacture of medicinal products in clean rooms increasingly stipulate quality assurance and control measures (Annex [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":2688,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-2670","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\/2670","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\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/comments?post=2670"}],"version-history":[{"count":6,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/posts\/2670\/revisions"}],"predecessor-version":[{"id":2686,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/posts\/2670\/revisions\/2686"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/media\/2688"}],"wp:attachment":[{"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/media?parent=2670"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/categories?post=2670"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/tags?post=2670"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}