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Pharma Supply Chain Finding The Gaps In Your Logistics Plan By Gail Dutton, contributing editor S upply chain gap analysis is moving from managing individual shipments to providing predictive forecasts that can improve an organization's overall supply chain performance. Gap analysis is a critical tool to assess processes throughout the supply chain, but it is only one tool needed to optimize a quality system. Abbott, for example, has an extensive, routine monitoring program as part of its supply chain risk management activities. According to Michael Douma, divisional VP of supply chain, global pharmaceutical operations at Abbott, "One hundred percent of shipments from both of our main distribution facilities are monitored. Metrics provide an objective basis for actions. They measure general performance and are used in risk management for root-cause analyses and in process improvement/optimization projects." Specific targets for the improvements are confidential, but include reducing the annual number of exceptions and thus enabling continuous improvements and better control in the shipping process. Monitoring is no longer focused solely on finished products. Now monitoring extends to the entire supply chain, starting with incoming ingredients and ending only when the product is in users' hands. As Douma underscores, "Managing supply chain temperature during manufacturing is a rapidly expanding area of focus by many countries' ministries of health. And, the issue of end-to-end supply chain temperature control routinely comes up during ministry of health meetings and customer audits." KEY SUPPLY CHAIN GAPS "Within logistics, the most frequent supply chain failures occur in transpor- 44 LifeScienceLeader.com tation and customs clearance – specifically around the handoff between freight forwarders and in-country brokers," Douma says. There also is a high potential for packaging or handling mistakes that may lead to temperature excursions when products are exposed to very different external environments during shipping. "For example, shipping products from winter in Chicago to summer in South America requires very robust packaging to manage the changes in temperature and humidity." Shipping from Chicago to Berlin, by contrast, is less challenging because environmental conditions are similar. Not surprisingly, logistics experts agree that, although all geographic areas have potential perils, the greatest risks are in developing markets. Each nation typically has different cold chain requirements and different interpretations of those requirements. Currently, for example, there are more than 30 different GDP (good distribution practices) regulations from organizations and nations, and more in development. For the same product, one country, for instance, may allow no temperature excursions while another may allow excursions of 1° to 2°C or more. Some require data loggers, while others accept indicators. There is no blanket policy for handling the same product around the globe. Working closely with their supply chain partners, including logistics providers, not April 2013 only helps organizations stay abreast of changing cold chain regulations, but also helps them identify areas needing improvement. By working together, Douma says, "We found a better definition of specific conditions during each stage of shipment and the potential risks. We also realized there is a need to educate all supply chain partners on GDPs and on supply chain temperature management." To identify gaps in policies, procedures, and their implementation throughout the supply chain, as well as conditions that contribute to packaging failure, pharmaceutical companies need to analyze all the relevant data relating to a shipment, including time, temperature, packaging solutions, transportation mode, and the exact path it takes to reach its destination (the lane). However, "The quality of data is more important than the quantity of data," stresses Niclas Ohlsson, CEO of TSS AB (a supplier of cold chain management solutions, including temperature monitoring), speaking at the 2012 IQPC Global Cold Forum. TEMPERATURE MONITORING EXPANDS Acquiring temperature data is an obvious first step in any cold chain gap analysis. Although equipment and facilities — including cold rooms — have been temperature mapped for years as part of good manufacturing processes (GMPs),