Global Track & Trace (GTT) was created in 2009 to support the Pharmaceutical Industry as it relates to the product serialization mandates affecting the constituents in the Pharmaceutical Supply Chain.

The GTT mission from inception was to foster global collaboration between the pharmaceutical supply chain partners to help educate and understand the impact of the Regulatory Mandates they face, while at the same time identifying business value and Change Impact for our members.

As part of this effort, GTT monitors global regulatory mandates, reports those updates to our members via the ‘Regulatory Update’ tab. We research the local market Ministries of Health teams, review the GS1 standards and make this data available to the GTT members to support their international compliance projects. Finally, GTT hosts bi-annual consortium meetings with industry participants to discuss and collaborate on ways companies affected by these regulations can meet the requirements.

Events

Stay tuned for Global Track & Trace – New Jersey this Fall 2019!

News

DSCSA Compliance: Industry is still in the trenches

Nov. 27, 2018, was to be a red-letter day in the 10-year program to implement an end-to-end pharma traceability system. Did industry meet the deadline?

“This is shaping up like Y2K did back in 2000,” says Greg Cathcart, CEO of Excellis Health Solutions. “A lot of work has been done; a lot of work is yet to do, and because of the grandfathering of unserialized product, it will be months or years until we’re where we need to be.”

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FDA Guidance for DSCSA released!

On September 19, 2018, the USFDA published a Draft Guidance, Product Identifiers Under the Drug Supply Chain Security Act – Questions and Answers, [Docket Number FDA-2018-D-3175-0002]. This draft guidance introduced some recommendations that were, at the very least, confusing if not confounding to the pharmaceutical supply chain’s strategy, systems, and validated processes that have been widely adapted for compliance to the DSCSA regulation.

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