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631 Results
Section: Logistics > Traceability/Serialization
Traceability/Serialization
FDA: New Supply Chain Draft Guidance
With public meetings on security and data exchange, FDA releases guidance that helps companies “define the relationship” with trading partners. The agency is soliciting comments.
August 30, 2017
New FDA guidance includes sections that discuss repackagers, WDDs, 3PLs and dispensers, with subsections for partners such as brokers and common carriers.
Traceability/Serialization
Beyond mandated efforts, be ready for real-world serialization needs.
Why is readying for November’s DSCSA mandates not enough for your serialization strategy to be successful?
August 20, 2017
Dscsa Serialization Strategy Cbre America
Traceability/Serialization
Pharma Supply Chain: Comments Due Sep 18!
The FDA is soliciting public feedback before the establishment of a pilot program under the DSCSA. Get your comments in soon.
August 17, 2017
The FDA is soliciting public feedback before the establishment of a pilot program under the DSCSA. Get your comments in soon.
Pharmaceuticals
Serialization Implementation Improves Par Pharma’s Efficiency
Par Pharmaceuticals benefits by employing analytics-based OEE tracking system that digitizes formerly manual data collection processes on multiple packaging lines.
August 3, 2017
An OEE Tracker computer screen capture shows a line view that shows the day’s OEE, as well as lines that are running, down or idle.
Traceability/Serialization
HDA Launches its “Origin” Repository
HDA’s first product offers a central point to ease DSCSA-required master data exchange.
July 31, 2017
Data sharing through the Origin repository. Source: HDA
Labeling/Printing
The Hidden Challenges of Serialization: Substrate Material
Part II of a three-part series looks at the importance of substrate materials in serialization.
July 18, 2017
Domino: Substate Material Composition.
Supply Chain
Poll Reveals Lack of Confidence in Contract Service Orgs, Line Vendors
When asked about serialization preparation, challenges, and trade partner readiness, respondents had some less-than-stellar feedback. And which topic is one of the most valuable business benefits AND a major concern?
July 11, 2017
TraceLink Inc. recently held its annual NEXUS 17 conference in Barcelona.
Robotics/Automation
Level 4 Serialization System Offers a Transformative Promise
A Level 4 system has the potential to usher in a new era of supply chain efficiency, transparency and compliance.
July 7, 2017
Level 4 systems are at the heart of a new and exciting digital paradigm for both manufacturers and consumers.
Pharmaceuticals
FDA Issues One-Year Delay in DSCSA Product Identifier Enforcement
DSCSA law does not change, but enforcement is pushed back to Nov. 26, 2018, says agency in June 30 draft guidance.
July 5, 2017
FDA issued a June 30 draft guidance document that delays enforcement until Nov. 26, 2018 of DSCSA product identifiers at the package level. (Photo supplied by Adents).
Traceability/Serialization
What’s the Biggest Serialization Hurdle?
New research from SEA Vision and Zenith Technologies points to technology selection as a major challenge, with many others not far behind.
July 5, 2017
New research from SEA Vision and Zenith Technologies points to technology selection as a major challenge, with many others not far behind. Source: SEA Vision
Materials
Lisbon Summit Advances Serialization Supply Chain
Event helps forge partnerships as U.S. and European pharmaceutical CMOs, CPOs and 3PLs share strategies for serialization compliance and optimize post-implementation operations.
June 30, 2017
Event helps forge partnerships as U.S. and European pharmaceutical CMOs, CPOs and 3PLs share strategies for serialization compliance and optimize post-implementation operations.
Inspection
Global Control Preferences Color New Serialization/Aggregation Lines
OEM APPLICATION NOTE: MGS focuses on small-footprint machinery that interconnects to other equipment on pharmaceutical lines and allows a single point of functionality.
June 27, 2017
MGS’s PV-600 carton inspection machine was unveiled in the U.S. at last March’s PACK EXPO East event.
Materials
Serialization Established for European Pharmaceutical CMO
Company implements serialization/aggregation on seven packaging lines at four sites in France to address requirements in multiple countries.
June 19, 2017
Company implements serialization/aggregation on seven packaging lines at four sites in France to address requirements in multiple countries.
Packaging/Filling
Apace Accelerates Track-and-Trace Operations
New solid-dose bottling line increases capacity, reduces labor costs and achieves Level 4 serialization and Level 3 aggregation.
June 13, 2017
Apace installed this integrated bottling line from NJM Packaging in 2017 to increase production volume.
Traceability/Serialization
Rumors Around the Industry: What’s Happening with Serialization Deadlines?
No word, official or otherwise, has come out regarding a delay in serialization deadlines, but will that remain the case?
May 26, 2017
Rumors Around the Industry: What’s Happening with Serialization Deadlines?
Pharmaceuticals
1/3 of Pharma Companies Aren’t Ready for Serialization
With the first serialization deadline quickly approaching, more than a third of pharma manufacturers and contract packagers aren’t prepared.
May 24, 2017
Serialization / Image: Cognex
Traceability/Serialization
Packaging and Serialization Experts Partner for Solutions
SGS signs strategic alliance agreement with Kezzler AS as a serialization technology provider for global customers, while Amcor offers packaging experience.
May 22, 2017
SGS signs strategic alliance agreement with Kezzler AS as a serialization technology provider for global customers, while Amcor offers packaging experience.
Pharmaceuticals
New Research Shows Companies Could Miss Serialization Deadlines
Companies that do embrace the changes and prioritize preparations for the DSCSA and the FMD have a real opportunity to differentiate their offering.
May 15, 2017
Companies that do embrace the changes and prioritize preparations for the DSCSA and the FMD have a real opportunity to differentiate their offering.
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