SUPPLY CHAIN
Transportation and Monitoring
PDA The Parenteral Drug Association (PDA) is an industry educational organization that provides detailed guidance regarding activities in drug development in technical reports available to its membership. Each report deals with specific technical, compliance, and monitoring requirements for a particular activity within drug development. Two cold chain management guidances pertain to establishing a cohesive cold chain strategy and governance structure: PDA Technical Report No. 39, revised 27: “Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment” (Suppl., vol. 61, no. S-2); and PDA Technical Report 46 Last Mile. TR39 provides a very detailed discussion of all the requirements of a cold chain management program from package design and qualification through good distribution practices. TR46 focuses upon good distribution practices of the final product.
IATA
The International Air Transport Association (IATA) is the trade association for the world’s airlines, representing 260 airlines and 83 percent of the total air traffic. IATA supports many areas of aviation activity and helps formulate industry policy on critical aviation issues. IATA provides several essential elements specific to cold chain requirements. The IATA has published a temperature control regulations (TCR) guide designed to help stakeholders involved in the transport and handling of pharmaceutical product to safely meet the requirements. The TCR defines industry best practices for drug manufacturers, ground handlers, freight forwarders and airlines. All healthcare temperature sensitive products require the IATA “Time and Temperature Sensitive” label. This label is specific to the healthcare industry and must be affixed to all shipments booked as time- and temperature-sensitive cargo to indicate the external transportation temperature range of the shipment. It is the responsibility of the shipper (or designated shipper’s agent by service agreement) to ensure that the label is applied properly.
Cold Chain Management Trends
1. Regulation is Increasing As the value of new drug therapies and their sensitivity to storage conditions has escalated, one might argue that drug manufacturers do not need any additional incentive to ensure environmental control. For years most countries require that pharmaceutical drug products remain within filed temperature limits. However, the EU’s guidance on Good Distribution Practices has extended this requirement to include transportation. While not required in the U.S., we anticipate a similar requirement and many organizations have already adopted temperature-controlled transportation as part of their current cold chain strategy. Biologics are not the only sector driving this practice: even controlled room temperature labeled products require refrigerated transport vehicles to minimize the potential for temperatures excursions.
2. Active vs. Passive Shippers
As logistics become more complex the risk profile of new drug therapies has prompted a shift toward greater environmental control. Passive shippers have been the method of choice for many years. Passive shipping configurations are manufactured systems that are typically insulated with polystyrene, polyurethane, or vacuum insulated panels. Many have been pre-qualified to hold a particular temperature for a certain amount of payload capacity for a specified period of time.
With these types of configurations, the shipper uses gel packs or similar materials to maintain the desired temperature. On the other hand, active shippers are powered by electricity and/or battery. Active shipping configurations are considered to be more secure than passive systems because units lock and are never opened during transport. As a result, this design helps reduce the risk of theft and may help maintain regulatory compliance. However, they have the disadvantage of requiring reverse logistics, meaning the containers must be returned to be reused adding cost and complexity to the logistical planning process.
3. Training Remains a Big Issue
With increasing regulation, the compliance component becomes even more critical. Training has always been a large part of cold chain management. To facilitate this organizations such as IATA provide a checklist for ground handlers and airlines to use to ensure the minimum verifications are conducted during the transport.
4. Increased Logistic Outsourcing
Cold chain performance is subject to the same pressures as normal supply chain process to push performance and drive down costs. Many pharma companies have turned to third party logistics (3PLs) firms that are incentivized to make the necessary investments in technology, infrastructure, and systems to drive continuous improvement and gain a competitive market edge. Specialized capabilities such as Automated Search and Retrieval Systems (ASRS) and in-situ x-ray verification of product are examples of tailored specialized capabilities that some 3PLs have adopted to meet the evolving demands of the cold supply chain.
Conclusion
As the value and criticality of life saving drug therapies escalate, regulatory requirements are moving toward closer control over every facet of the cold chain. Even with the disparity in formal requirements among different markets, drug manufacturers and 3PLs are gravitating to the most conservative requirements to drive standardization and ultimately efficiency. With the informal adoption of more stringent requirements, the ability for each piece of the cold supply chain to comply with industry best practices will be challenged. Training will continue to be an issue as ground crews, freight forwarders, and airlines navigate the confusion between absolute requirements and desired practice. Industry organizations such as IATA have attempted to drive standardized work through the use of checklists for freight forwarders and airlines to follow, however the reality is that the ability of these ground teams to stay on top of these responsibilities remains problematic. The success metrics of today’s cold chain are at best a moving target with formal and informal regulation complicating today’s global supply chain. Collaboration among external service providers could provide the foundation for future compliance risk reduction and potential business success.
Bikash Chatterjee has guided the successful approval of over a dozen new pharmaceutical and biotech products within the U.S. and Europe and developed and transferred products and processes to satellite operations and Contract Manufacturing Organizations over much of his 30-year career. He has extensive experience with design and implementation of systems to satisfy requirements for ICH Q8, Q9, and Q10 as well as e-pedigree and the application of risk-based approaches in the area of validation. Mr. Chatterjee is a member of the USP National Advisory Board and is the Past-Chairman of the Golden Gate Chapter of the American Society of Quality. He is the author of "Applying Lean Six Sigma in the Pharmaceutical Industry” (ISBN: 978-0-566-09204-6). Mr. Chatterjee holds a B.A. in Biochemistry and a B.S. in Chemical Engineering from the University of California at San Diego.
Pharmaceutical Outsourcing | 24 | July/August 2016
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