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246 Results
Type: News
Section: Logistics > Traceability/Serialization
Pharmaceuticals
Carton Serialization Helps Idifarma Meet EU Falsified Medicines Directive
Spanish contract development and manufacturing organization (CDMO) Idifarma makes €200k investment to meet forthcoming EU serialization regulations.
February 7, 2018
Spanish contract development and manufacturing organization (CDMO) Idifarma makes €200k investment to meet forthcoming EU serialization regulations.
Pharmaceuticals
TraceLink Dismisses Litigation Claims Against HDA
TraceLink and HDA will work together with other industry players to propose interoperable standards and guidelines for pharmaceutical product master data, with the purpose of enabling compliance with the DSCSA.
February 6, 2018
TraceLink and HDA will work together with other industry players to propose interoperable standards and guidelines for pharmaceutical product master data, with the purpose of enabling compliance with the DSCSA.
Pharmaceuticals
OPEN-SCS Group Addresses DSCSA Transaction Documentation
Lack of packaging standards could threaten serialization data integrity, says speaker during FDA meeting on drug distribution security.
January 25, 2018
Dirk Rodgers speaks at recent FDA public meeting on enhanced drug distribution security.
Traceability/Serialization
Antares Vision to Open Software Development Center in Ireland
New center in Galway will create more than 50 jobs in computer vision and artificial intelligence.
January 22, 2018
Massimo Bonardi, Managing & Technical Director for Antares Vision (left) and Emidio Zorzella, CEO of Antares Vision (right).
Pharmaceuticals
Recipharm Equips Three More Facilities for U.S. Serialization
With today’s DSCSA deadline, CDMO Recipharm now has nine locations able to supply serialized products to the U.S.
November 27, 2017
With Nov. 27, 2017's DSCSA deadline, CDMO Recipharm now has nine locations able to supply serialized products to the U.S. Shown here is product labeling on a Recipharm packaging line.
Pharmaceuticals
Report Predicts Track-and-Trace Will Be a Game Changer
Report assesses the global anti-counterfeit pharmaceutical packaging market between 2016 and 2026.
November 10, 2017
Report predicts track-and-trace will be a game changer in the global anti-counterfeit pharmaceutical packaging market through 2026.
Traceability/Serialization
Live from HDA Traceability: Most-Asked Question of the Day
Software, grandfathering and barcodes are major points of interest, but does this low-tech question suggest a need for future guidance?
November 9, 2017
Does this low-tech serialization question suggest a need for future guidance?
Pharmaceuticals
Praxis Packaging Ready for DSCSA Deadline
With the DSCSA enforcement delay, manufacturers and contract packagers such as Praxis are refining their serialization programs.
October 13, 2017
Praxis Packaging is ready to meet the DSCSA deadline. Seen here is a Praxis cleanroom.
Pharmaceuticals
Open-SCS Group Showcases Packaging Serialization Standard
At PACK EXPO Las Vegas, the organization launched a pilot to test initial communications among global pharma industry group members. The release of a validated standard is projected by Nov. 2017.
October 2, 2017
At PACK EXPO Las Vegas, the organization launched a pilot to test initial communications among global pharma industry group members. The release of a validated standard is projected by Nov. 2017.
Traceability/Serialization
Spotted at Healthcare Packaging EXPO: AR Glasses
On display at booth N-219, Microsoft and Adents team up to create augmented reality glasses as a control tool for serialized pharma products.
September 25, 2017
Adents Prodigi
Cannabis
Serialization and Medical Marijuana Take Center Stage
Two special events at Healthcare Packaging EXPO/PACK EXPO Las Vegas provide exclusive perspectives on two of the most pressing issues in the life sciences arena.
September 19, 2017
Healthcare Packaging EXPO logo
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
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.
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
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.
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.
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