When Cubist Pharmaceuticals tracked its active pharmaceutical ingredient (API) shipments from Italy to the US, it identified several unknown delays. Most, according to Cubist’s supply chain consultant, Michele Johnson, speaking at the recent IQPC Cold Chain & Temperature Management Global Forum, were caused by the need to re-ice or by other materials handling issues.
Attending to such issues en route improves product viability, but each touch also increases the risk of improper handling, tampering, cargo diversion, and other dangers.
Clearly, what you don’t know can hurt – especially if you don’t know what it is that you don’t know. That’s where GAP analyses comes in. GAP analyses help organizations identify what they don’t know, enabling them to bridge the gap between where they are and where they want to be either from their processes, Quality Management System and Regulatory Compliance.
Analyzing the cold chain holistically is key. For example, not long ago it was enough that cargo reached its destination on time and undamaged. Gradually, carriers began tracking handoffs and sharing that information with shippers. Now, validated monitoring technology further increases supply chain visibility and compliance, making it possible not only to track shipments in real time but to monitor their environmental status and intervene through Quality Assurance.
Once Cubist learned of the extra stops, it streamlined its supply chain and reduced handoffs. Johnson & Johnson and AstraZeneca also are using monitoring data to gain deep supply chain insights used to develop a number of new SOPs and training programs. In the end, the company will retain full control of their supply chain, maintain product integrity and comply with regulations. By identifying critical parameters for a Quality Management System, in shipping, packaging, and warehousing procedures, as well as current and pending regulations, shippers better understand their cold chain environment. By comparing their processes and procedures to industry benchmarks, analyzing differences, and determining the relative benefits they confer, companies gain the information necessary to improve. Rather than allow what they don’t know to hurt them, savvy shippers are taking the initiative to understand and identify gaps in their cold chain management process that, when filled, can provide competitive advantages.
Infitrak™ is a leading provider of cold chain compliance services and intelligent monitoring solutions. With over 15 years experience in cold chain compliance and since the launch of the Infitrak™ environmental monitoring platform in 2004, the company has successfully delivered solutions to a loyal customer base that includes pharmaceutical manufacturers, wholesalers, laboratories, logistics and storage companies, hospitals, food manufacturers and data centers.
About Cubist Pharmaceuticals
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment.