{"id":89,"date":"2026-02-20T07:22:27","date_gmt":"2026-02-20T06:22:27","guid":{"rendered":"https:\/\/dev.snark-gfx.com\/en\/our-commitments\/frilab-quality-standards\/"},"modified":"2026-03-20T18:07:02","modified_gmt":"2026-03-20T17:07:02","slug":"frilab-standards-and-practices","status":"publish","type":"page","link":"https:\/\/dev.snark-gfx.com\/en\/our-commitments\/frilab-standards-and-practices\/","title":{"rendered":"Frilab Standards and Practices"},"content":{"rendered":"\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:75%\">\n<h2 class=\"wp-block-heading\">CEP and DMF Certifications\u00a0<\/h2>\n\n\n\n<p><strong>The CEP \u2013 Certificate of Suitability to the European Pharmacopoeia<\/strong>&nbsp;<\/p>\n\n\n\n<p>The <strong>CEP<\/strong> (Certificate of Suitability to the Monographs of the European Pharmacopoeia) is a document issued by the <strong>EDQM<\/strong> (European Directorate for the Quality of Medicines).&nbsp;<\/p>\n\n\n\n<p>It certifies that an active substance or an excipient complies with the monograph of the European Pharmacopoeia, including, where applicable, requirements related to <strong>TSE\/BSE<\/strong> risks.&nbsp;<\/p>\n\n\n\n<p>The CEP confirms that the quality of the substance can be adequately controlled through the corresponding monograph, with additional tests if necessary.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">The DMF \u2013 Drug Master File\u00a0<\/h3>\n\n\n\n<p>A <strong>DMF<\/strong> (Drug Master File), or <strong>ASMF<\/strong> in Europe (Active Substance Master File), is a confidential dossier submitted to regulatory authorities. It describes:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The manufacturing of an active pharmaceutical ingredient (API)\u00a0<\/li>\n\n\n\n<li>Analytical methods\u00a0<\/li>\n\n\n\n<li>Quality controls\u00a0<\/li>\n\n\n\n<li>Specifications of the substance\u00a0<\/li>\n<\/ul>\n\n\n\n<p>Its purpose is to demonstrate the <strong>quality and purity<\/strong> of the API in accordance with regulatory standards (FDA, EMA).&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Good Distribution Practices Certificates (GDP\/GDP)\u00a0<\/h3>\n\n\n\n<p>Compliance with <strong>GDP<\/strong> (Good Distribution Practices \u2013 BPD\/GDP in French) is mandatory for laboratories and logistics operators.&nbsp;<\/p>\n\n\n\n<p>GDP ensures:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Quality\u00a0<\/li>\n\n\n\n<li>Integrity\u00a0<\/li>\n\n\n\n<li>Full traceability of medicines\u00a0<\/li>\n<\/ul>\n\n\n\n<p>throughout the entire supply chain, from manufacturing to final delivery.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Good Manufacturing Practices (GMP)\u00a0<\/h3>\n\n\n\n<p>Good Manufacturing Practices constitute a set of regulatory requirements aimed at ensuring the reproducibility of manufacturing processes by imposing standards and guidelines designed to establish a quality system that guarantees:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Risk control\u00a0<\/li>\n\n\n\n<li>Full traceability of all manufacturing operations\u00a0<\/li>\n<\/ul>\n\n\n\n<p>These practices are essential to ensure the <strong>protection of patient safety<\/strong>.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">FRILAB Practices\u00a0<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Manufacturers\u00a0<\/h3>\n\n\n\n<p>FRILAB aims to select partners who use raw materials certified through a <strong>DMF<\/strong> or <strong>CEP<\/strong>, and prioritizes working with manufacturing sites compliant with <strong>European GMP \/ BPF<\/strong> standards.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Distribution\u00a0<\/h3>\n\n\n\n<p>All manufactured medicines are stored with three key partners located in France.&nbsp;<br>All of them are <strong>GDPcertified<\/strong> and hold full pharmaceutical authorization.&nbsp;<\/p>\n\n\n\n<p>For example, they provide:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Temperaturecontrolled warehouses\u00a0<\/li>\n\n\n\n<li>A fully compliant cold chain\u00a0<\/li>\n\n\n\n<li>Strict adherence to the <strong>FEFO<\/strong> method (First Expired, First Out)\u00a0<\/li>\n\n\n\n<li>Dedicated geographic coding systems\u00a0<\/li>\n\n\n\n<li>A countryspecific pricing database\u00a0<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3. Exportation\u00a0<\/h3>\n\n\n\n<p>We guarantee the shipment of our products worldwide, by sea or air, in full compliance with applicable regulations.&nbsp;<br>This includes the implementation of <strong>temperaturecontrolled transport<\/strong>, whether directed logistics or refrigerated (\u201ccold chain\u201d) shipments, monitored using temperature probes directly integrated into the goods.&nbsp;<\/p>\n\n\n\n<p>Thanks to this, FRILAB is able to comply with all <strong>Incoterms<\/strong> required by our clients.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">4. Availability and Access to Healthcare\u00a0<\/h3>\n\n\n\n<p>In every country where FRILAB Laboratories are represented, we ensure our products remain continuously available by monitoring all supply flows and guaranteeing a <strong>safety stock<\/strong> in each territory.&nbsp;<\/p>\n\n\n\n<p>Our objective is clear: <strong>ensure continuous patient access to our products<\/strong>.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">5. Our Pharmaceutical Certifications\u00a0<\/h3>\n\n\n\n<p>Certifications are issued by <strong>Swissmedic<\/strong> and can be consulted via the <strong>SwissGMDP<\/strong> database.&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>FRILAB Operating License:<\/strong> <strong>PDF<\/strong>\u00a0<\/li>\n\n\n\n<li><strong>FRILAB GDP Certificate:<\/strong>\u00a0<br>https:\/\/www.swissgmdp.ch\/establishments\/sites\/MP_1002438\u00a0<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:25%\">\n\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>CEP and DMF Certifications\u00a0 The CEP \u2013 Certificate of Suitability to the European Pharmacopoeia&nbsp; The CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) is a document issued by the EDQM (European Directorate for the Quality of Medicines).&nbsp; &hellip; <a href=\"https:\/\/dev.snark-gfx.com\/en\/our-commitments\/frilab-standards-and-practices\/\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":13,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"page_longue.php","meta":{"inline_featured_image":false,"tableau":"","footnotes":""},"class_list":["post-89","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/dev.snark-gfx.com\/en\/wp-json\/wp\/v2\/pages\/89","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.snark-gfx.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/dev.snark-gfx.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/dev.snark-gfx.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.snark-gfx.com\/en\/wp-json\/wp\/v2\/comments?post=89"}],"version-history":[{"count":7,"href":"https:\/\/dev.snark-gfx.com\/en\/wp-json\/wp\/v2\/pages\/89\/revisions"}],"predecessor-version":[{"id":334,"href":"https:\/\/dev.snark-gfx.com\/en\/wp-json\/wp\/v2\/pages\/89\/revisions\/334"}],"up":[{"embeddable":true,"href":"https:\/\/dev.snark-gfx.com\/en\/wp-json\/wp\/v2\/pages\/13"}],"wp:attachment":[{"href":"https:\/\/dev.snark-gfx.com\/en\/wp-json\/wp\/v2\/media?parent=89"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}