Wednesday, December 1, 2021

Everything you need to know about Pharmaceutics Track and Trace

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It's possible to track and trace medications to locate every item in your supply chain at any given time. No pharmaceutical company can do without this sophisticated technology when it comes to tracking and tracing products and sharing supply chain data.

Track and trace for pharmaceuticals have been our business for nearly 20 years, longer than any other solution provider, and we decided it was a good moment to revisit the foundations.

Tracking and tracing drugs has numerous advantages.

Track and trace systems for pharmaceuticals perform precisely what they say they will if designed and executed appropriately. Everything from drugs to vaccines to medical devices may be tracked and traced back through the supply chain using track and trace system.

Every item in your supply chain may be tracked thanks to the use of tracking technology. Among its many advantages are improved operating efficiency and speed, protection from theft and diversion, maintenance of product safety and environmental stability, and the prevention of the supply chain from being contaminated with counterfeit, adulterated, or expired drugs.

It's possible to keep track of everything in your supply chain thanks to traceability. Quick and efficient product returns, sophisticated recall management; brand protection; consumer confidence are only a few of its numerous advantages.

Track and trace pharmaceuticals

By combining technologies and processes, pharmaceutical tracking and trace are possible. A product may be followed and traced around the clock, authenticated at any point (e.g., before to sale, upon dispensing, or during a recall), and turned into a digital asset with multiple benefits and applications thanks to serialization; which is its "building block."

Serialized products must support the various operations and data points derived from track and trace. The DSCSA's "T3" data is used to provide those additional data points for the U.S. Drug Supply Chain Security Act (transaction history, transaction statement, transaction information).

The European HUB (EU HUB) and country-specific databases called the National Medicines Verification System (NMVS) aggregate these data points in Europe (NMVS). The National Track and Trace solutions are used in Russia.

How standard are the requirements for tracking and tracing?

It's becoming more common for authorities to combine serialization with track and trace to help them combat counterfeit, stolen, or tainted medications.

Manufacturers must produce T3 data for medications at the lot level to begin the track and trace procedure, for example, as detailed by the U.S. DSCSA at the moment. A copy of the T3 data must be sent to all supply chain stakeholders, including wholesalers, repackagers, and dispensers. If they are selling the product, they must also produce and contribute to the T3 data.

Recalled or returned pharmaceuticals will be easily traced back through the supply chain when the DSCSA standards are entirely implemented in November 2023, which is the target implementation date. To do this, a shift from low-level to unit-level tracking and tracing will be implemented.

The DSCSA is a fascinating organization.

The DSCSA has been a primary priority since the beginning of our blog, bulletins, and website.

We've conducted a successful FDA-approved trial for the Verification Router Service, tracked changes in deadlines, created white papers, and studied impending needs in great detail. It has been a busy year for us, with four successful webinars, including "Plan for DSCSA Readiness" and "DSCSA 2023."

If you have any queries concerning the DSCSA, don't hesitate to contact us. As we endeavor to serialize the whole pharmaceutical supply chain in the United States, we are your one-stop shop for information.

Conclusion

Increasingly, pharmaceutical companies are putting themselves at risk by not implementing track and trace for their products. They can be fined or imprisoned, have their drug licenses revoked, and be barred from specific lucrative markets.

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