An Outline of WDSrx’s Plan for Cold Chain Logistics
The storage, handling and transport of temperature regulated pharmaceutical drug products in the U.S. is expected to be a $12.6 billion business in 2016, an increase of nine percent compared with 2015. According to trade journal Pharmaceutical Commerce, the 9% growth rate for pharmaceutical cold chain logistics services is twice the increase relative to all pharmaceutical drug products.
According to one estimate, pharmaceuticals requiring cold-chain handling are expected to rise from the current 19% of total global pharmaceutical logistics spending to 22% by 2020 representing $16.7 billion of a $93.8 billion industry.
The engine for the impressive growth in pharmaceutical cold chain logistics is due to the emergence of biologics in the marketplace. Biologics are medical products derived from natural sources including microorganisms, human or animal components.
Many biologics require refrigeration to maintain potency and safety.
In addition, new regulations in the United States increased the quantity of drugs requiring temperature-controlled handling at all temperature ranges including many within the Controlled Room Temperature (15 to 25C) category.
WDSrx is expanding 3PL services to meet the growing demand for biologics and other specialty pharmaceuticals. A client approached WDSrx about a vaccine product requiring cold chain procedures for delivery throughout their U.S. distribution network.
As a Third Party Logistics provider exclusively focused on the life sciences industry, WDSrx complies with strict requirements set by federal, state and other regulatory bodies concerning the receipt, storage and handling of pharmaceutical drug products.
Recent Good Distribution Practice (GDP) regulations put in practice at WDSrx facilities require greater oversight and monitoring of shipments at all temperature levels – Controlled Room Temperature (CRT), Refrigerated and Frozen ranges.
The client required a comprehensive plan that included temperature stability not only for storage at the temperature stated on the label but also within the approved range during transportation.
The WDSrx Quality Assurance and Regulatory Compliance team researched several packaging options to comply with regulatory and client requirements during transport. The product specifications required innovative thinking and solutions to achieve the objective.
It was determined that the optimal solution would minimize risk and loss, incorporate contingency capabilities and deliver multiple proactive problem-resolution procedures.
Packaging for temperature-regulated products fall into Active and Passive categories. Active solutions utilize an energy source to maintain temperature integrity. Passive systems use materials including water/ice or dry ice during transport.
During the short and intense testing period, the WDSrx team experimented with multiple packaging and shipping options to determine the safest and most efficient method to transport the product while maintaining temperature consistency.
The recommended solution that was approved by the client is comprised of a single wall insulated container that meets all construction requirements of the specified freight classification packed with moisture-resistant frozen and fridge-rated cold packs. Packaging components also include a Temperature Logger and a Warm Mark indicator to indicate any deviation.
“Product protection at all temperature ranges is an important priority to assure client satisfaction and patient health,” states WDSrx President Adam Runsdorf. “Additional rules for handling temperature-regulated product require a continuing substantial investment in Information Technology support and employee training to maintain integrity within the pharmaceutical supply chain.”
Close collaboration with the client resulted in a program to receive, store and distribute their pharmaceutical drug product efficiently and safely within a strict temperature range.
The multi-disciplinary approach involved expertise from teams within WDSrx and the client in Information Technology, Warehousing and Distribution, Quality Control and Regulatory Compliance.
Packaging is only one element of the entire pharmaceutical supply chain. Success also depends on a robust information technology network, skilled people with proper training to carry out specialized procedures, continuously updated documentation reflecting the most recent regulatory guidelines for temperature regulated products and robust customer service capabilities.
EXPERTISE IN COLD CHAIN LOGISTICS AND SERVICES
In 2013 European regulators established new good distribution practice (GDP) guidelines for the handling of temperature regulated pharmaceutical drug products that are being adopted in the United States and around the world.
WDSrx regularly evaluates current temperature regulated capabilities and explores additional capabilities to better serve clients.
Warehousing and Distribution: Details regarding the receipt, storage and fulfillment of temperature regulated pharmaceutical drug products are provided by the WDSrx Warehousing and Distribution department. Each cold-chain program requires unique procedures to maximize efficiency and minimize temperature deviation within the supply chain.
Temperature Regulated Environments: Complex regulations govern the handling and transport of temperature-regulated pharmaceutical drug products. The quantity of drugs requiring specialized procedures and oversight is increasing at all temperature ranges – CRT, Chilled, Frozen, Deep Frozen and Cryogenic. WDSrx establishes high levels of efficiency within the pharmaceutical supply chain with minimal risk or product loss.
Quality Control and Regulatory Compliance: Every successful pharmaceutical cold chain logistics solution ultimately relies on the expertise and training of the team responsible for carrying out instructions. The WDSrx Quality Control and Regulatory Compliance team examines the most recent GDP guidelines concerning handling of temperature regulated pharmaceutical drug products. Information is regularly incorporated into SOPs (Standard Operating Procedures) that govern actions based on weather conditions, product specifications, storage requirements, documentation and compliance. Updated procedures are then taught to team members who receive regular skills training.
Transportation Management: “Ship-to-Label” regulations require that temperature-regulated pharmaceutical drug products are maintained within the stated temperature range during storage and also during transport. The WDSrx Transportation Management department collects all pertinent data about delivery specifications to determine the most efficient and effective method to fulfill client requirements. As an independent company, WDSrx works with several trusted and approved air freight forwarders to maximize available options and minimize risk.
Information Technology: Rules for maintaining compliance within the pharmaceutical supply chain are becoming more complex. In addition to increased regulations, regulatory authorities are increasing the compliance requirements for an expanding list of medicines not previously covered by temperature-control oversight including many CRT (Controlled Room Temperature) products. The WDSrx Information Technology team is responsible for monitoring, collecting and transmitting data about temperature, humidity and other variables to assure standards are maintained that assure patient health.