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World Courier Achieves Coveted GxP-Compliant Status Worldwide with Focus on GDP, Quality Management

Dépèche transmise le 17 novembre 2009 par Business Wire

World Courier Achieves Coveted GxP-Compliant Status Worldwide with Focus on GDP, Quality Management

STAMFORD, Conn.--(BUSINESS WIRE)--Combining an extensive review of international Good Practice (GxP) and Quality Management standards with the successful implementation of company-wide compliance processes, World Courier’s global company-owned transportation network of over 140 offices in 50 countries worldwide meets all necessary standards for GxP-compliant status as it applies to the courier/transport industry.

“We believe that no other company within the international express courier sector has attained GxP compliance on such a global scale,” says Wayne Heyland, president and CEO of the World Courier group of companies.

“GxP”, a general term for the Good Practice quality guidelines and regulations used in many fields including the pharmaceutical industry, is designed to ensure product safety and integrity during the manufacturing, control, storage and distribution phases. Although the basis for the transportation/courier industry rests primarily in Good Distribution Practice (GDP), it also embraces requirements from Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Storage Practice (GSP).

In formalizing its GxP-compliant status, World Courier has completed an extensive review of all applicable guidelines and regulations, developed a company-wide GxP policy, implemented a series of company-wide processes to ensure strict compliance to identified requirements and appointed a worldwide team of Quality Assurance specialists to monitor quality and ensure system-wide regulatory compliance on the local, regional and corporate level.

“Our strength as an organization hinges on a consistent worldwide approach to quality and strong internal quality measures,” says Mr. Heyland. “Our true value proposition lies in our extensive global network of company-owned offices dedicated to and specializing in the transport of investigational drugs, biological samples and related supplies. All our people are universally trained to the same high standards, share proprietary state-of-the-art technology, systems and SOPs, and remain dedicated to delivering quality clinical trial support services worldwide. These unique attributes enable us to effectively establish and monitor global GxP standards for compliance on a truly worldwide basis.”

“In today’s environment of increased regulatory scrutiny, the biopharmaceutical industry demands the very highest quality standards in order to meet all regulatory and ethical requirements,” maintains Dr. Ruediger Lomb, World Courier’s Global Director, Quality and Technical Compliance. “Global GxP compliance is now even more critical given the substantial increase in the number of studies being conducted in developing countries, often under challenging circumstances. Our emphasis is on the successful day-to-day application of systems and processes in every single location – both in well established and new growth markets – not merely as a ‘bolt on’ solution to selected locations.”

World Courier’s fully integrated GxP-compliant service system encompasses the temperature-controlled transport of investigational drugs, biological samples and ancillary supplies; GMP-compliant investigational drug storage and distribution depots in eleven strategic and emerging markets; and a worldwide team of temperature specialists experienced with a full range of thermal containment products.

Through this service system, World Courier delivers true process control to the pharmaceutical industry, ensuring the integrity and stability of investigational drugs and biological samples used in global clinical trials, guaranteeing the availability of independently verifiable data and supporting the industry’s need to successfully qualify suppliers and sub-contractors participating in their supply chain.

About World Courier

Incorporated in 1969 and headquartered in Stamford, Connecticut (USA), World Courier is the largest and most experienced specialty courier service with a network of over 140 wholly-owned ISO 9001-certified offices operating in 50 countries worldwide. World Courier has set the benchmark for worldwide time- and temperature-sensitive transportation and is an acknowledged leader in delivering customized solutions, temperature-control and value-added services.

World Courier also operates the world’s largest integrated company-owned network of GMP-compliant investigational drug storage facilities in developing and strategic locations, with depots in Argentina, Australia, Brazil, Chile, China, Colombia, India, México, Perú, Russia and South Africa.