{"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":"2026-09-29T16:28:47","modified_gmt":"2026-09-29T14:28:47","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<h2 class=\"wp-block-heading\"><strong>CEP &amp; DMF Certifications<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. CEP \u2013 Certificate of Suitability to the European Pharmacopoeia<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia)<\/strong> is a certificate issued by the <strong>EDQM (European Directorate for the Quality of Medicines &amp; HealthCare)<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It certifies that an <strong>active pharmaceutical ingredient (API)<\/strong> or an <strong>excipient<\/strong> complies with the requirements of the relevant <strong>European Pharmacopoeia monograph<\/strong>, including, where applicable, compliance with <strong>TSE\/BSE (Transmissible Spongiform Encephalopathy\/Bovine Spongiform Encephalopathy)<\/strong> risk management requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A CEP confirms that the quality of the substance can be adequately controlled through the corresponding Pharmacopoeial monograph, supplemented by additional tests where necessary.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. DMF \u2013 Drug Master File<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A <strong>DMF (Drug Master File)<\/strong>, referred to in Europe as an <strong>ASMF (Active Substance Master File)<\/strong>, is a confidential regulatory dossier submitted to health authorities.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It provides detailed information regarding :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Manufacturing processes for the active pharmaceutical ingredient<\/li>\n\n\n\n<li>Analytical testing methods<\/li>\n\n\n\n<li>Quality control procedures<\/li>\n\n\n\n<li>Substance specifications<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The purpose of the DMF\/ASMF is to demonstrate the <strong>quality<\/strong>, <strong>safety<\/strong>, and <strong>purity<\/strong> of the active pharmaceutical ingredient in accordance with regulatory requirements established by authorities such as the <strong>EMA<\/strong> and the <strong>FDA<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Certificates &amp; Good Pharmaceutical Practices<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Good Distribution Practice (GDP) Certificate<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Compliance with <strong>Good Distribution Practices (GDP)<\/strong> is essential for pharmaceutical laboratories and logistics operators.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">GDP standards ensure the quality, integrity, and traceability of medicines throughout the entire supply chain, from manufacturing to final delivery.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Good Manufacturing Practice (GMP) Certificate<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Good Manufacturing Practices (GMP)<\/strong> consist of a set of regulatory requirements designed to ensure the consistency and reproducibility of manufacturing operations.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">These standards establish a robust quality management system that guarantees :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Risk control and mitigation<\/li>\n\n\n\n<li>Full traceability of manufacturing operations<\/li>\n\n\n\n<li>Product quality and consistency<\/li>\n\n\n\n<li>Patient safety protection<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>FRILAB Practices<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Sales Force Training<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u201cA Strategic Investment for Commercial and Scientific Performance\u201d<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In an increasingly competitive, regulated, and demanding pharmaceutical environment, medical representatives can no longer be limited to simply presenting products. They must become true scientific partners to healthcare professionals, capable of providing reliable, relevant, and tailored information that meets prescribers&#8217; needs.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Continuous training of the sales force is therefore a key driver for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Increasing commercial performance<\/li>\n\n\n\n<li>Strengthening scientific credibility<\/li>\n\n\n\n<li>Improving the quality of interactions with healthcare professionals<\/li>\n\n\n\n<li>Ensuring compliance with regulatory and ethical requirements.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Manufacturing<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">FRILAB prioritizes partnerships with manufacturers whose raw materials are supported by a <strong>DMF<\/strong> or a <strong>CEP<\/strong> and seeks to work primarily with production facilities operating in compliance with <strong>European GMP standards<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This approach ensures the highest levels of pharmaceutical quality and regulatory compliance.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>3. Distribution<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">All manufactured medicines are stored and distributed through three strategic pharmaceutical logistics partners located in France.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Each of these facilities is fully <strong>GDP-certified<\/strong> and holds the necessary pharmaceutical authorizations.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Key distribution practices include :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Temperature-controlled warehouses<\/li>\n\n\n\n<li>Validated cold-chain management<\/li>\n\n\n\n<li>Application of the <strong>FEFO (First Expired, First Out)<\/strong> methodology<\/li>\n\n\n\n<li>Differentiated geographic product coding<\/li>\n\n\n\n<li>Country-specific pricing databases<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">These measures ensure product integrity, traceability, and supply chain efficiency.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>4. Export Operations<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">FRILAB guarantees the worldwide shipment of pharmaceutical products by sea and air in full compliance with international regulations.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This includes the use of :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Validated temperature-controlled transportation systems<\/li>\n\n\n\n<li>Refrigerated (\u201ccold chain\u201d) logistics when required<\/li>\n\n\n\n<li>Temperature-monitoring devices integrated into shipments<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">As a result, FRILAB is able to comply with the full range of <strong>Incoterms<\/strong> requested by its customers while maintaining product quality throughout transportation.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>5. Product Availability &amp; Access to Healthcare<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">In every country where FRILAB products are marketed, we actively monitor supply levels to ensure continuous product availability.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Our commitment includes :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ongoing supply chain supervision<\/li>\n\n\n\n<li>Demand forecasting and inventory management<\/li>\n\n\n\n<li>Maintenance of safety stock levels within each territory<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Our objective is simple : to ensure uninterrupted patient access to essential healthcare solutions.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>6. Our Pharmaceutical Certifications<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Certificates are issued by Swissmedic and can be consulted through the SwissGMDP database.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>FRILAB Pharmaceutical Authorization &amp; GDP Certificate:<\/strong> <a href=\"https:\/\/www.swissgmdp.ch\/establishments\/sites\/MP_1002438\">https:\/\/www.swissgmdp.ch\/establishments\/sites\/MP_1002438<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CEP &amp; DMF Certifications 1. CEP \u2013 Certificate of Suitability to the European Pharmacopoeia The CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) is a certificate issued by the EDQM (European Directorate for the Quality of Medicines &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":21,"href":"https:\/\/dev.snark-gfx.com\/en\/wp-json\/wp\/v2\/pages\/89\/revisions"}],"predecessor-version":[{"id":1334,"href":"https:\/\/dev.snark-gfx.com\/en\/wp-json\/wp\/v2\/pages\/89\/revisions\/1334"}],"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}]}}