World Courier is delighted to announce that its 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.

‘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).

The formalization of World Courier’s GxP compliance comes after an extensive review of international Good Practice (GxP) and quality management standards, the development of a company-wide GxP policy, the successful implementation of additional processes designed to enhance the company’s current ISO 9001 program, and the appointment of a global quality assurance team to monitor quality and ensure system-wide regulatory compliance on the local, regional and corporate level.

Single-minded, system-wide focus on quality

“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 of the World Courier group of companies – an achievement, he suggests, that has been accomplished only because of the scope of the World Courier network and its unwavering focus on the special needs of the pharmaceutical industry.

“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, GxP is the cornerstone of the industry’s need to meet independent quality, regulatory and ethical standards,” maintains Dr Rüdiger Lomb, World Courier’s global director, quality and technical compliance.

“Global GxP compliance has never been more critical than it is today, especially 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 quality systems and processes in every single location where we operate – both in well established markets and in new growth markets – not merely as a ‘bolt on’ solution to selected locations.”

Benefits to industry

With a fully GxP-compliant transport and supply chain system in place, World Courier meets evolving industry requirements for the managing of time- and temperature-sensitive clinical trial materials used in global studies.

By utilizing World Courier’s integrated service system, customers will ensure that all aspects of their pharmaceutical transport and storage needs are safeguarded – from the temperature-controlled transport of investigational drugs, biological samples and ancillary supplies to and from research sites and locations worldwide right through to the storage and distribution of clinical trial materials from any of the company’s eleven strategically located GMP-compliant investigational drug depots. World Courier’s experienced team of temperature specialists rounds out the service offering, providing recommendations and delivering the right packaging solutions from a range of thermal containment products. From start to finish, the entire system is monitored by a global QA team who ensure regulatory compliance at each step of the way.

Through its GxP-compliant service system, World Courier delivers true process control to the pharmaceutical industry. Without exception, the integrity and stability of every pharmaceutical shipment used in a global clinical trial is ensured. The availability of independently verifiable data is guaranteed. The industry’s need to successfully qualify suppliers and sub-contractors participating in their supply chain is assured. Customer oversight through a transparent audit program is welcomed.

“While we are delighted to offer this valuable credential to the pharmaceutical industry, this is simply a logical continuation of the many systems and processes we have put into practice over the past twenty years and will continue to develop over the coming years,” says Mr Heyland. “As the concept of ‘quality’ continues to evolve, our mission is to ensure that we evolve with it, and that we continue to lead – not follow – industry standards in this critical area.”

For more information on World Courier, its service offering or GxP compliance initiative, please contact your local World Courier office or visit World Courier’s website.