World Courier / GxP Compliance
Introduction
In November 2009, World Courier officially announced that the
transport side of its business had achieved GxP-compliant status.
When combined with our GMP-compliant CTSCS investigational drug storage network, World Courier is the
first international express company able to deliver
a fully GxP-compliant transport and storage supply chain system to biopharm customers.
This represents the logical "next step" in providing pharma customers with "a service no one else can deliver".
What is GxP?
"GxP" is a general term for the Good Practice quality guidelines and regulations used in many fields including the pharmaceutical and food industries, where "G" stands for "Good", "P" stands for "Practice" and "x" represents the variable guideline descriptor (i.e. Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Storage Practice (GSP)).
In regulated industries, these guidelines are used to ensure product safety and integrity during the manufacturing, control, storage and distribution phases.
World Courier's GxP Policy
Key drivers of World Courier's Good Practice policy are the international Good Distribution Practice (GDP) standards. This policy also draws on elements of GMP (Manufacturing), GSP (Storage) and GCP (Clinical) as it pertains to the courier/transport industry.
This policy broadly defines how GDP (and other) guidelines are applied to World Courier's core transportation business and operations. It covers such topics as organization and management; Quality Management; personnel and training; the management of premises, vehicles and equipment; labeling and containers; dispatch; documentation; complaints; sub-contractors; and self-inspection.
Why is this necessary?
GxP compliance is becoming an increasingly "hot" topic as the pharmaceutical industry seeks to ensure the security of its supply chain and conform to increased regulatory scrutiny. While the GDP compliance of transport companies/couriers has always been a requirement, it has not traditionally been enforced. As a result, transportation providers could well be perceived as one of the "weakest links" in the supply chain as all other laboratory, production and clinical trial activities already conform to pharmaceutical good practice guidelines.
By realizing GxP compliance, World Courier can claim enhanced operational control and quality assurance capabilities and a clear competitive advantage over other service providers.
Benefits to clients
With a fully-integrated GxP-compliant service system in place, World Courier can:
- deliver true process control to the pharmaceutical industry
- ensure the integrity and stability of investigational drugs and biological samples used in global clinical trials during transit and storage
- guarantee temperature data that clients can independently verify
- support the biopharm industry's need to successfully qualify suppliers and sub-contractors participating in their supply chain
World Courier Hungary Kft.
1103 Budapest, Gyömrői út 128.
T: +36(1)431-0550
Fax: +36(1)431-0555
www.worldcourier.com
e-mail:
wcbudops@worldcourier.hu
