By David Bang
The term cold chain refers to the time-and-temperature-controlled transportation of temperature-sensitive products from the manufacturer to the end user. The goal of cold chain management is to provide patient safety, product integrity, regulatory compliance, process optimization, and cost optimization.
Emerging markets are increasing the requirements for quality control, highlighting the importance of proper documentation for the importation of temperature-sensitive products. Canada, Saudi Arabia, Singapore, Malaysia, Brazil, and Argentina are among the countries that have made the documentation of individual shipments of temperature-sensitive products a customs entry requirement. How will you and your organization react to these regulatory changes?
Integrated Cold Chain Data
Storage and transport needs have shifted as the proportion of biologics in new product pipelines and portfolios has grown. Integrated cold chain data corresponds to the integration of temperatures, storage conditions, logistics milestones, packaging performance, and quality data. This gives rise to an intelligent portal which provides analytical views of an organization’s various needs in cold chain logistics.
It is commonly understood that transportation processes should be qualified rather than validated because processes are not possible to control in the real world, and all variables can impact the process. If the transportation process is not rigorously measured and continuously improved via systematic handling of relevant deviations and corrective actions based on integrated cold chain data, it will not be robust enough to succeed due to the endless intricacies and sheer complexity of the cold chain in global logistics. This can lead to the cold chain process being more susceptible to irregularities and negative outcomes (loss of product and/or product getting stuck in customs) from health authorities’ audits or even import permit revocations. Undoubtedly, more than ever before, data management and integration has become critical to the success of the cold chain.
Data integration involves conversion of data into useful and meaningful interpretations and actions. The main question at hand is this: How can cold chain data be utilized to predict and determine when a problem will occur before it happens, with the goal of mitigating product issues and their resulting impact costs? The answer lies in technology that will enable cold chain data to be integrated and interpreted in an intelligent, meaningful, and useful manner. Simultaneously, technology will minimize risks and inversely provide practical applications for various uses of data and environments that are customer- and product-specific.
Applications Of Data for Patient Safety
Life science professionals in different areas and levels of supply chain, manufacturing, packaging, operations, quality, and compliance have one common goal in mind: patients. However, their needs to interpret and analyze cold chain data to make risk-based decisions on global cold chain networks can vary substantially. Nonetheless, it all comes down to “unknown unknowns” because there are things in the cold chain that we don’t realize we don’t know. As per the FDA: Adulterated Drug Products, FD & C Act Chapter V, sec. 501, “A drug or device shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and the purity characteristics, which it purports or is represented to possess.” It takes a great amount of control to protect the integrity of temperature-sensitive medicinal products.
As temperature-sensitive products are shipped all over the world, ask yourself about your cold chain management goals for this year. Are data management capabilities a target for your organization? With the aptitude of data integration and management, life sciences organizations will be able to increase the speed for product release into the market, produce significant gains in productivity, maintain high levels of maximum regulatory compliance, and create cost optimization while conserving product integrity.
David Bang is the CEO for LifeConEx, a DHL company dedicated to advanced cold chain management. Bang has held various positions in global contract acquisition, implementation, sales, finance, IT, and strategy within the life sciences industry.