Quality principles are not just fundamental; they’re essential, particularly in industries like pharmaceuticals and life sciences. In this context, DeSpir’s adoption of Good Distribution Practices (GDP) isn’t merely a step towards excellence within the North American logistics industry; it’s a significant stride that impacts and benefits the entire pharmaceutical and life sciences sector.
It All Started with A Question
Ron Devitt, Co-founder/ Managing Partner, spearheaded this initiative by posing a fundamental question that ignited DeSpir’s journey towards GDP: “How can we minimize risk during the transportation of pharmaceutical products while maximizing benefits for our clients?” His leadership and foresight led to the company-wide adoption of the GDP to the highest Gold Standard of the EU Good Distribution Practice for Medicinal Products for Human Use Guidelines and the WHO Annex 5 Good Distribution Practice for Pharmaceuticals, established guidelines by many countries’ healthcare regulatory agencies.
Making & Transporting Medicines
Pharmaceutical products can only be licensed by healthcare regulatory bodies if they are manufactured in facilities that meet the Good Manufacturing Practice (GMP) standards. These guidelines ensure that the products are produced and controlled consistently to meet quality standards. Following strict procedures throughout the manufacturing process ensures the safety, efficacy, and quality of the final product.
Raw materials are delivered to manufacturing facilities or finished products are delivered to hospitals or pharmacies. At this stage, the products enter an uncontrolled environment. Good Distribution Practice (GDP) is a set of guidelines that ensures the safe storage, transportation, and distribution of medicinal products. It aims to maintain the quality, integrity, and effectiveness of pharmaceuticals by adhering to regulatory standards. GDP benefits both shippers and customers by ensuring quality assurance, compliance, customer safety, reliability, and satisfaction. It protects the effectiveness and security of medicines by ensuring that everyone in the transportation supply chain is trained and understands how to handle them. Quality processes and procedures are put in place to support this goal.
Quality Best Practice = Best-in-Class Pharmaceutical Logistics Service
“GDP establishes a process and structure to align our customers’ standards and expectations regarding the treatment of their goods once they leave their warehouse with our own. We effectively become an extension of their internal quality standards,” says Nikki Schwartz, Head of Strategic Business.
As early adopters of quality and security, DeSpir is well-established and continuously improving, benefiting from the flexibility and capacity of a logistics intermediary with the quality management and standards demanded by global high-value shippers and their partners. Since 2014 DeSpir has specialized in transporting high-value loads and embraced TAPA (Transport Asset Protection Association) standards for security. However, when you add time and temperature sensitive products into the mix there are regulatory and moral obligations that need to be met, as there is a patient at the end of a haul.
DeSpir works with many US shippers, logistics companies, and third-party logistics providers who need trucking capacity. One of the main risks for the pharma industry is that their time and temperature-sensitive cargo is subcontracted or double-brokered to trucking companies that need to be trained and equipped to comply with quality standards.
Air Cargo News reports, “The biopharma industry loses approximately $35 billion annually as a result of failures in temperature-controlled logistics, according to IQVIA Institute for Human Data Science.”
DeSpir: A Better Service Provider
“CargoNet reported that documented strategic cargo theft events increased 430% year-over-year from 2022-2023. Those statistics include fictitious pick-ups, wherein criminals or organized crime groups exploit facilities using fake IDs to collect goods. The number of fictitious pickups recorded by CargoNet increased by 600% year-over-year, with most occurrences happening in California. However, adhering to GDP standards significantly mitigates this risk through robust processes and procedures. At DeSpir Logistics, we prioritize security and reliability in our operations. We meticulously vet and train our 70 Qualified Carriers for handling High-Value Time-Temperature (HVTT) and pharmaceutical shipments, following our SOP QA-0106. Carriers must meet stringent eligibility criteria encompassing insurance, equipment, and personnel qualifications. Upon qualification, they commit to adhering to DeSpir’s Quality Management System (QMS). Furthermore, our drivers and key personnel undergo biannual training and testing on shipment protocols, security awareness, and contingency procedures. They also receive TSA training for Air Cargo handling. To ensure the integrity of our climate-controlled trailers, temperature mapping is conducted every 18 months or after significant repairs. Additionally, our Risk Management Team conducts annual audits to assess carrier performance, assigning rankings of Bronze, Silver, or Gold based on capabilities. This proactive approach underscores our commitment to mitigating cargo crime and mishandling, ensuring the security and integrity of your products,” explained Evan Berna, Senior Manager of Carrier Strategy.
“We know who is collecting your products; we have vetted, trained, and worked with our network of qualified carrier partners to ensure your critical cargo is transported safely,” continued Berna.
0% of DeSpir’s customers have experienced a strategic theft.
DeSpir’s commitment to delivering the highest standards of quality isn’t just a statement; it’s a practice ingrained in every member of their team. Ron’s dedication to quality led him to recognize the importance of GDP in ensuring the integrity of the products being transported and, ultimately, the satisfaction of their customers. Eunice Martin, VP of Quality, seamlessly carried forward Ron’s vision. “This commitment is reinforced by the fact that every team member is well-versed in GDP requirements and a significant number of Operations Teams are fully trained on GDP. Moreover, department heads go the extra mile by undergoing Responsible Person for Pharmaceutical Logistics training. This comprehensive training reflects DeSpir’s belief that quality should not be a central enforcer’s responsibility but ingrained in every department, instilling confidence in their expertise and dedication to quality.”
Setting the Standard
DeSpir’s proactive approach to quality management, exemplified by its early adoption of GDP, showcases its unwavering dedication to excellence. By making quality a central focus of its operations and empowering its team to uphold the highest standards, DeSpir sets a precedent for the trucking industry and reaffirms its position as a leader in the field.
