Globalization and an increase in the number of food safety and pharma counterfeit incidents are prompting governments to tighten regulations on production and supply chains. Establishing preventive measures and harmonizing regulations are major issues for the food and pharma industries.
For years, pharmaceutical mandates in most countries required products to be maintained within manufacturer-established guidelines only in storage. But in November 2013, the European Union (EU) guidelines on Good Distribution Practice for medicinal products for human use went into effect, extending temperature requirements to transportation, and expanding coverage to include over-the-counter drugs.
In the EU, about 80 percent of pharma products now require temperature-controlled transportation. Anticipating similar regulations in the United States—and considering the potential for exporting these drugs—many pharmaceutical manufacturers are adopting this approach in the United States, too.
The phasing-in of rules stemming from the U.S. Food and Drug Administration’s prevention-focused Food Safety Modernization Act, passed in 2011, is triggering investment in solutions to document every step in the food supply chain. Products such as produce must be traceable all the way back to the point of origin. Recall systems must be reliable and efficient, not only to rapidly comply with more stringent regulations, but to limit the scope by isolating specific batches of product.
Getting out ahead of such regulation is a common theme across cold chain logistics. Manufacturers are building more stringent practices into their requirements, and 3PLs and other providers are investing in additional credentials. Atlanta-based cold chain 3PL Americold, for example, plans to have 14 sites certified by the Safe Quality Food Initiative by the end of 2015, and Lineage Logistics is aiming for certification across all of its business units by 2020.