Many companies have begun implementing serialization solutions and are working towards integration with contract manufacturing organizations (CMOs), 3PLs and trading partners. As companies’ respective deadlines approach, these efforts will drive investment in integrated supply chain and IT solutions, though many are struggling with which entity or departments will carry the costs.

THE REGULATORY LANDSCAPE

Over the past several years, global regulatory agencies have introduced or expanded upon regulations and guidance for life sciences companies. Whether specifically addressing supply chain, quality, IT or marketing elements, the ultimate intent is to protect and empower consumers. Multinationals are perhaps most impacted by the regulations, particularly considering the infrastructure and resources available in certain markets and fluctuations within the global economy. To maintain product safety and efficacy throughout the global supply chain, the World Health Organization has been working with regulatory bodies to harmonize Good Distribution Practices (GDP) across nations.

Specifically within the United States, the Drug Supply Chain Security Act (DSCSA) requires that manufacturers, repackagers, wholesalers and third party logistics providers (3Pls) implement means to transmit product and transaction information and determine the validity of product over a 10-year period (2013 to 2023). By November 27, 2017, all manufacturers must ensure that each drug package and homogenous case carries a product identifier, including a unique standard numerical identifier (SNI). Manufacturers will also be required to provide transaction details in electronic form, verify suspect product at the package level, and maintain product identifier records for six years or more, by the deadline.

Many companies have begun implementing serialization solutions and are working towards integration with contract manufacturing organizations (CMOs), 3Pls and trading partners. As companies’ respective deadlines approach, these efforts will drive investment in integrated supply chain and IT solutions, though many are struggling to determine which entity or departments will carry the costs.

For more, please download this eBook, designed by Generis Group, and created from the insights of Clarkston Consulting on The Serialization Challenge.