FOR IMMEDIATE RELEASE
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World
Courier Achieves Coveted GxP-Compliant Status Worldwide with Focus on GDP,
Quality Management
With a fully GxP-compliant transport and supply
chain system in place, World Courier meets the most demanding industry requirements
for managing time- and temperature-sensitive clinical trial materials used in
global studies.
“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. Rüdiger 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
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
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Contacts
World Courier Management Inc.
Dr. Rüdiger Lomb
Global Director, Quality &
Technical Compliance
Telephone: + 49
30 24 31 42 0
Email: rlomb@worldcourier.de
Noel Foucart
Director Global Marketing
Telephone: +32 (0)2 712 50 80
Email:
Website: www.worldcourier.com