Assuring patient safety in a globalized world: Merck KGaA is member of the Rx-360 consortium

For ensuring product quality and patient safety, the pharmaceutical industry needs secure and reliable global supply chains delivering materials that can be trusted by manufacturers, health practitioners and patients. In order to promote this goal, Merck actively participates in the Rx-360 consortium : a non-profit organization of companies from the pharmaceutical and biotech industry with the mission to implement standards and processes that guarantee product quality and authenticity throughout the entire pharmaceutical supply chain. 

Managing the pharmaceutical supply chain
In the face of globalized distribution of both drug components and finished drugs, management of the pharmaceutical supply chain has become one of the top public safety concerns worldwide. Safety problems arise due to insufficient communication, unethical players, or non-compliant suppliers, among other things. Thus counterfeited, adulterated or contaminated materials are brought on the market, often with tragic consequences. Authorities around the world answer these threats by implementing local measures to increase patient safety, but international cooperation and mutual efforts on a global scale are needed as well in order to provide the consistency and worldwide scope required for sustained success.

Rx-360: International pharmaceutical supply chain consortium
That’s why in 2009 the international Rx-360 consortium was founded by leading pharmaceutical and biotech companies and suppliers to the industry. Rx-360 is conceived as a global, volunteer-based, not-for-profit organization with a broad and inclusive membership. Small and large companies alike, brand and generics makers, suppliers or distributors are welcome to contribute to the development of harmonized standards for quality and supply chain safety.

Harmonized standards – increasing compliance, quality and authenticity
Rx-360 aims at creating enhanced, standardized global quality systems and processes that help its members ensure product quality and authenticity throughout their supply chains. This includes establishing and maintaining voluntary industry standards for the quality and authenticity of supplies (APIs, chemicals, excipients and packaging materials) in alignment with regulatory requirements, developing audit standards as well as audit training and certification programs, and organizing independent and shared supplier audits. Moreover, monitoring and the exchange of information regarding supplies and suppliers will be facilitated, and a seal is to be adopted that can be used by Rx-360 members meeting the consortium’s high standards.

Merck at the forefront of quality improvements
Merck has always put quality at the center of its work: Not only does Merck use the latest quality management systems and offers various supplier audits for its customers, as a founding member of Rx-360, Merck also deploys its resources and expertise as both manufacturer and supplier to help the consortium achieve its mission. In September 2010, Merck hosted a two-day Rx-360 conference in Darmstadt – the first one of its kind held in Europe – where Merck’s representative was re-elected to the Rx-360 Board of Directors. Merck will continue to use all its powers for better component and drug quality, enhanced security of the global supply chains and improved patient safety.

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