Our Commitment High quality standards and a comprehensive quality assurance We guarantee optimum quality in all processes: starting with the careful selection of products and suppliers. We pay sincere attention to the delivery stage, the proper storage, and the final transport to our partners. Quality. Effectiveness. Safety. We stand for the quality, effectiveness, and safety of all medicines and medical devices we offer. Our product range includes only commonly used medicines with a proven positive benefit-risk-profile and medical devices with an approved benefit. We meet all legal requirements of the German and European legislation and commit ourselves to comply with international regulations on the quality of drug substances, raw materials, medicines, and medical devices. The medicines are manufactured by various drug manufacturers in Europe and Asia, and meet international quality standards as well as the current guidelines of the British (BP), European (Ph.Eur.), and United States (USP) pharmacopoeias. Appropriate and cost-effective services action medeor labworks also offers trainings and advice on how to improve the use of equipment and how to run the facility more effectively. Our mutual aim: finding the most suitable, cost-effective solution. Qualified and committed staff In order to meet our principles, we depend on qualified and committed employees. Each employee of action medeor labworks strives to provide safe, effective, and reliable medicines and medical devices with the aim of improving health worldwide. Our staff is devoted to implement the demands of our customers and to understand those as an opportunity for continuous improvement. It is our aim to deliver the highest quality and flawless products on time at the most competitive cost possible. Certificates and licenses To ensure compliance with international principles and EU standards for all medical products, we monitor our processes and partnerships via GMP, GDP, ISO and CE certification standards. As pharmaceutical entrepreneur we have a wholesaler’s license according to §52a of German pharmaceutical law. We have a GDP certificate (“Good Distribution Practices”) according to EU law. We are subject to inspections of the state authority in charge (District Government of Düsseldorf, Germany) that reviews the compliance to regulatory drug guidelines. Our quality assurance system is certified according to DIN ISO 9001. We also take into account the quality assurance regulations of DIN ISO 13485 for the distribution of medical devices. Certificate - ISO 9001107 KB Certificate - Good Distribution Practice (GDP)1.1 MB Certificate - Großhandelserlaubnis (German)1.08 MB Certificated. Prequalified. Supervised. We guarantee optimum quality in all processes: starting with the careful selection of products and suppliers and paying sincere attention to the delivery stage, proper storage, and final transport to our partners. GMP-compliant manufacturing Our suppliers of medicines produce in line with the international WHO-GMP standards (“Good Manufacturing Practices”). The authorities in charge in the respective country as well as additional international authorities inspect the manufacturers regularly. In addition to that, action medeor labworks conducts audits of the contract manufacturers accompanied by international pharmaceutical experts. Certificates according to the WHO Certification System are part of our quality documentation. These “certificate(s) of a pharmaceutical product” contain information about the manufacturer, the GMP-compliant production and the regular inspection by control authorities. Diligent pre-qualification of suppliers Every potential manufacturer has to pass the pre-qualification process, before being considered as a supplier. We examine the quality-relevant documents such as the manufacturer’s license, Site Master File or external audit reports. Our pharmacists also conduct quality inspections of our suppliers on a regular basis. In the course of the product-specific calls for tender, every potential manufacturer has to fill in a product questionnaire, which is evaluated by our pharmacy department. Apart from checking compliance to the specifications (mostly Ph.Eur., BP, USP), we inquire about many other details such as stability data, registrations and quality of the Active Pharmaceutical Ingredient (API). Internal quality control and quality assurance Upon arrival of the goods at the warehouse of action medeor labworks, every product undergoes strict quality control procedures. First of all the medicines are carefully inspected in the quarantine area according on documented processes. Whenever necessary, additional quality control tests are carried out in WHO-prequalified laboratories. Quality assured lots are released by the responsible pharmacist. Only then can the medicines be transferred to the released-goods warehouse and are ready for dispatch. Standard Operating Procedures (SOPs) are in place for all the processes action medeor labworks undertakes to ensure the quality and safety of medicines. The SOPs are regularly checked and updated by the head of Quality Assurance. GDP-compliant delivery We cooperate with shipping companies that are specifically selected. Even for deliveries in crisis regions, we aim to ensure transport according to GDP (“Good Distribution Practices”), which safeguards the quality during transportation by truck, air or sea. In order to monitor the storage temperature of the shipment until it is delivered to our partners, we add so-called temperature loggers to all deliveries dispatched from our warehouse. ContactDr. Irmgard Buchkremer-Ratzmann, Management TPL_PHONE 02156 9788-500 TPL_EMAIL This email address is being protected from spambots. You need JavaScript enabled to view it.
