GxP Compliance

At World Courier, GxP compliance means holding ourselves to a higher standard, because we believe our customers deserve nothing less. All parts of our business, from transport and storage processes to our depots themselves, comply fully with GxP standards.

Our GxP policy is founded on the established precepts of Good Distribution Practice (GDP), Good Storage Practice (GSP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). World Courier associates have extensive knowledge of international GxP and Quality Management standards. These practices are just one part of the way in which we expedite and enhance the global clinical trial process, ensure product quality and integrity, minimize risk, increase efficiency, and optimize the supply chain for our customers. 
 

The formalization of World Courier’s GxP compliance comes after:
•    Extensive review of international Good Practice (GxP) and Quality Management standards
•    Development of a company-wide GxP policy
•    Successful implementation of additional processes that enhance the company’s current ISO 9001:2008 program
•    Appointment of a global quality assurance team to monitor quality and ensure system-wide regulatory compliance on the local, regional and corporate level

Additional Quality Management Measures
World Courier has also put in place an independent Quality Management System (QMS) that complements our GxP policy and conforms to leading international quality management and oversight programs. This QMS includes:
•    A corrective and preventive actions (CAPA) program
•    A change management program
•    A management review program
•    A process performance/product quality monitoring program
•    Standard operating procedures, as well as global and local instructions
•    An internal audit program (QA)
•    ISO 14001 and 9001 compliance programs
•    A self-inspection program (QC)
•    Complaint management
•    A risk assessment approach for decision-making
•    Qualification/validation programs
•    Calibration/preventive maintenance programs

World Courier also complies with other quality systems, such as the ISO 9000 and ISO 14001 series.

Additionally, the World Courier Quality System goes beyond a typical QMS by including all the elements suggested by ICH Q10, a modern, holistic approach to quality management that prioritizes innovation and continual improvement in order to minimize risk and facilitate sustainable process controls. These elements include:
•    Compliance with good practice rules (GxP)
•    Elements from ISO 9001 and 14001, including the concepts of management review, performance review, and continuous improvement
•    A global SOP framework
•    Elements of quality risk management

For more information on our quality, compliance or GxP applications, or to request a copy of our GxP compliance policy, please communicate directly with the Office of the Vice President, Global Quality & Technical Compliance