Track & Trace

As pharmaceutical manufacturers, distributors, repackagers, and dispensers seek secure and cost-effective ways to meet new regulations under the U.S. Drug Supply Chain Security Act (DSCSA), the TraceLink Life Sciences Cloud has quickly become the preferred track and trace platform for conducting DSCSA compliant transactions between supply chain trading partners -- and ensuring that critical medicines reach patients the safest, most secure, and most timely manner possible.

Clinical Packaging syringe marking and grouping; 70/minute; patient specific coding

The need to track every little detail regarding your product and its journey is one that is often overlooked, but research shows that 63 percent of those asked say that supply chain visibility is a “high priority for improvement”.

Global track-and-trace requirements have increased the complexity and demands on supply chains. Now, more than ever, pharmaceutical companies need to deploy applications, services and mobile solutions that satisfy many parallel goals. Pharmaceutical companies must consider areas of compliance, product integrity, product visibility and risk reduction, all while running supply chains at full speed and low cost. The decision to serialize and track products opens up a whole new range of options and can provide value-added benefits for pharmaceutical companies beyond basic compliance.

Vetter has announced a major milestone in the issue of drug safety. The contract development and manufacturing organization (CDMO) now offers the option of clearly identifying packaging used for drugs. Vetter's comprehensive and flexible serialization service is in response to stricter guidelines from the regulatory authorities of many countries aimed at combatting counterfeit drugs. Pharma and biotech companies can use Vetter's individually customizable solutions as a basis for their own track-and-trace programs to optimize their supply chain.

The US FDA has started work on a national track and trace system for pharmaceuticals after President Barack Obama signed the Drug Quality and Safety Act into law last night.

David DeJean, VP, Center of Excellence, Systech International, was the presenter for this Pharma EXPO discussion on best practices in implementing serialization. He emphasized that while serialization is a good first step in helping brand owners to recognize their own products in the supply chain, the possibility for many errors still exists, especially with serialization systems that are not fully integrated across multiple global sites.

Oschmann first acknowledged the work of Eli Lilly CEO John Lechleiter, outgoing IFPMA president. In the past two year two years under Lechleiter’s watch, the IFPMA accomplished great work including the “fight the fakes” anti-counterfeiting campaign, science-based regulatory pathways for biosimilars, regulatory convergence, particularly in Asia and Africa, and the Consensus Framework for ethical collaboration.

The Industrial Internet of Things (IIoT), a term coined by Richard Nass of Automation World, is transforming how manufacturers do business. A $14 trillion industry—with manufacturing representing 27 percent of the pie, according to Manufacturing.net—the IIoT is comprised of hardware and software, tools, systems integration, the factory network, and the cloud. And it's enabling manufacturers to do things they only dreamed about even five years ago.

FDA unclear if it will allow for leniency early in 2015 when the first set of track and trace requirements go into effect Jan. 1; industry still without FDA guidance on standards for exchanging transaction information throughout the pharmaceutical supply chain.