The industry has been talking about, and slowly working toward, track-and-trace for many years. Now Pharma faces real deadlines that require action. There are different players in the mix, and they face different deadlines for meeting requirements. The most pressing deadline for pretty much everyone, however, is the mandate that they begin tracking prescription drug lots starting in 2015. Two years later, the industry must begin assigning serial numbers to individual "saleable units" of every prescribed product sold in the U.S. Anticipating this, some players are wondering: "What do I do now?"
ShipX® Trax is a rail freight management solution that tracks, traces and proactively monitors shipments. Trax provides superior data for railcars and inventory-in-motion, creating a secure platform for shippers. It allows viewing access for their buyers, letting them see in-transit goods across multiple carriers, offers sales-on-track to both parties in real-time and provides shippers with real-time visibility to all of their railcar shipments across multiple Class I and Shortline railroads
With a vision to ensure safety and sanctity of their animal health medications, a global pharmaceutical and biotech manufacturer has selected and implemented Xyntek and Antares serialization technology to protect their animal health brand.
New cloud computing technologies are enabling breakthrough innovations in supply chain management (SCM) applications delivered via software as a service (SaaS) models. As a key enabler in this new digital world, cloud computing can have a transformational impact on the business and the supply chain operating model by enabling data and analytics, mobility and social media functions.
This is an outstanding example 3 Coesia companies in the IPS-Division (Industrial Process Solutions) working together for customers benefit. The track & trace system S-TTS from Laetus in combination of the inline printing from Hapa and the automated production flow made by Flexlink bring turn-key solutions to your plant.
Octapharma, one of the largest independent manufacturers of human protein products worldwide, has added the PAS-X Track & Trace Serialization Aggregation to Werum's PAS-X at their production site in Vienna.
On October 8, 2014, the FDA published a draft Guidance for Industry, The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers. The purpose of the guidance is to clarify the effect of the law on both industry and state governments and to clarify the effect of the track and trace requirements where State requirements have been developed. Comments are due within 60 days.
While track-and-trace has made inroads into pharmaceuticals (see GS1 weighs in on current track-and-trace developments), there remains somewhere around the next bend the use of traceability to help improve safety in the supply chain for packaged foods. We went to the source to find out more, asking GS1 for an update on the status of traceability for food packaging. Responding to our inquiry in this Q&A is Angela Fernandez, vice president of retail grocery and foodservice, GS1 US.
Lasers are used in different ways for processing medical devices. Laser marking machines with integrated vision systems emerged as an effective means of identifying medical components, e.g. for marking UDI compliant codes
Lasers are used in different ways for processing medical devices. Laser marking machines with integrated vision systems emerged as an effective means of identifying medical components, e.g. for marking UDI compliant codes.
NetDespatch, the Software as a Service (SaaS) parcel data management platform and Blackbay, provider of mobility-enabled solutions for the transport and logistics industry, today announced a global strategic partnership that will greatly expand collaboration between the two organisations.
Counterfeiters managed to get fakes of some of Roche's ($RHHBY) top-selling cancer drugs, including Herceptin and MabThera/Rituxan, into the European market this summer. This, among other issues, has motivated Roche's Genentech to have specialty distributors handle these recently counterfeited drugs, as well as Avastin. This decision has outraged some hospitals.
Two years after contaminated drugs from a compounding pharmacy killed 64 and sickened 750 with meningitis, the industry still struggles with serious safety problems and recalls affecting thousands of patients.
TraceLink Inc., the leader in protecting patient safety and enabling health for global Life Sciences, announced today the latest version of their Life Sciences Cloud platform and Product Track application for end-to-end Drug Supply Chain Security Act (DSCSA) compliance.
With the fairly recent DQSA (Drug Quality and Security Act), plus new regulations in China for GSP, and the EU for GDP, plus rumors that Japan will be adopting the EU GDP guidelines, it seems that global regulations are becoming harmonized. These regulations are based upon quality, risk mitigation, and the measures taken to prevent adulteration or ...
The anti-counterfeit market is broadly divided on the basis of application as food & beverages, pharmaceuticals, and others, for this study. Others include electronics, clothing, consumer goods, entertainment, automotive equipment, and many more. With a huge market potential and growing awareness about counterfeiting, the market is likely to witness considerable growth in the years to come. In 2013, food & beverages acquired the largest share as an application of anti-counterfeit packaging; however, the market for pharmaceutical is projected to grow at the highest rate.
The European Stakeholder Model (ESM) is a partnership of organisations involved in the pharmaceutical supply chain. The ESM partners have joined forces to develop a safe, cost-effective and partnership based pan-European medicines verification system to combat falsified medicines and ensure patient safety.
One of the best sessions during last week’s LogiPharma conference held in Princeton, NJ was called “Staging Your Implementation To Meet The 2017 Deadline”. The “deadline” refers to the November 27, 2017 deadline for drug manufacturers to apply unique serial numbers to all drug packages and cases shipped into the U.S. market as required in the Drug Supply Chain Security Act (DSCSA), but it can also refer to similar deadlines with similar requirements in a number of other regions of the world. The panel included knowledgeable representatives from two of the largest global pharma manufacturers selling into the U.S. market. Both manufacturers are facing serialization mandates in the E.U., Brazil, Turkey, South Korea, China, India, Argentina and a few countries in Africa as well as the U.S.
Various packaging technologies, such as tamper-evident closures and authenticity identifiers (e.g., holograms, taggants, security inks), are available to help combat counterfeiting (see sidebar). Packaging alone, however, doesn’t stop counterfeiters, says Fletcher, “Counterfeiters are adept at making authentic-looking packaging. Authentication technologies, such as holograms or marks on the package, are not effective at the consumer level because consumers typically don’t know what the authentic package or medicine should look like or if a change was made by the manufacturer.”
BEEYOND is a consulting company in the field of disruptive innovation, accompanying established companies on out-of-the-core growth strategy, from creation of new concepts to product launch. Reach us at: contact@beeyond.fr.
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