GS1 Global Standards Gaining Traction as Drug Serialization Deadlines Loom

GS1’s globally harmonized serial number approach continues to gain traction as pharmaceutical manufacturers seek to navigate the complicated maze of international regulatory requirements and comply with their looming deadlines.

The requirement for serialization – the unique identification of individual products – is coming into force around the world as part of the global effort to identify authentic product and combat counterfeit medicine introduction into the legitimate supply chain.

The increasing traction of global numeric identifiers and how it addresses some of the key challenges that firms are facing was highlighted by GS1 US Healthcare Director Robert Celeste at PDA’s annual Pharmaceutical Cold Chain Management Conference in Bethesda, Maryland in early March.

Celeste explained that GS1 is a 35-year-old not-for-profit organization with headquarters in Brussels, Belgium and Princeton, New Jersey, that creates standards.   “What we do is we help look at the global standards and how to apply them to the local scene as far as regulatory compliance and also business practices.”

GS1 is the most widely used supply chain standards system in the world, he explained, with over one million companies across 150 countries using the standards in over six billion transactions a day.

[Celeste’s explanation of the potential power of the GS1 system in helping address the global pharmaceutical supply chain problems is provided for subscribers here.  The full story can be purchased for $95 by contacting Karen Bertani (  For subscription information click here.]