Regulatory: Page 47

Traceability/Serialization
Survey Reveals Serialization’s Potential Across Industries
New survey reports that companies across different industries consider the most important advantages of serialization to be protection against brand and product piracy and greater transparency in the logistics chain.
February 13, 2018
MT track-and-trace study cover.
Traceability/Serialization
Hicof: Ultra-Compact Serialization
Spotted at PharmaPack: Switzerland-based Hicof has designed a system for coding and labeling that measures just over a meter long.
February 8, 2018
Amacoder
Medical Device/Packaging
Packaging Cliffs Notes: MDR’s Pertinent Updates
Live from PharmaPack Europe, Thierry Wagner lists the key MDR safety and performance requirements for sterile medical packaging and talks sterile barrier symbols.
February 7, 2018
Sterile barrier symbol
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
Carton Serialization Helps Idifarma Meet EU Falsified Medicines Directive
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 Dismisses Litigation Claims Against HDA
Traceability/Serialization
Verification Router Service Update
As an outgrowth of the Healthcare Distribution Alliance's 2019 saleable returns pilot work, the group has been exploring a VRS as an option for compliance to support DSCSA verification requirements.
February 6, 2018
VRS
Robotics/Automation
Adents: Cloud-Based Pharmaceutical Serialization
Online demo platform serves as a user-friendly tool to “test drive Cloud-based Adents Prodigi traceability offering.
February 5, 2018
Adents: Cloud-Based Pharmaceutical Serialization
Pharmaceuticals
FDA Fast Tracks Zika Vaccine
The FDA granted ‘fast track’ status to TAK-426, Takeda’s Zika vaccine, in hopes of easing the international public health emergency.
February 2, 2018
Takeda
Pharmaceuticals
Can Unit-Dose Packaging Reduce Opioid Abuse?
Though not a mandate, FDA Commissioner Gottlieb recognizes that blister packaging could help alleviate addiction, abuse and overdosing of medications such as opioids and loperamide.
January 31, 2018
Can Unit-Dose Packaging Reduce Opioid Abuse?
Pharmaceuticals
Careful, Your Laxative Might Not Be a Laxative
Magno-Humphries Laboratories recalled Senna Laxative tablets because the bottles were actually filled with pain relievers.
January 26, 2018
Senna Laxatives
Pharmaceuticals
FDA OK’s Mayo Clinic’s Automated Stem Cell Producer
The FDA has granted the Mayo Clinic permission to use an automated bioreactor-based stem cell production platform at Jacksonville campus.
January 25, 2018
Stem Cell Producer
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.
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Sealed sterile syringe with needle in clear plastic packaging on dark background
Medical Device/Packaging
When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
Manufacturers who treat ISO 11607's worst-case clauses as a risk-management tool, rather than a box to check, are far better positioned to keep their packaging, and their products, performing as intended.
Researcher in lab coat examining mannequin head with blue eye patches during cosmetic or skincare product testing
Pharmaceuticals
Are Bacteria Cellulose Face Masks the Future of Skin Health?
Technician in hairnet and blue shirt working at industrial machinery in laboratory setting
Packaging/Filling
How an Integrated Leaflet Simplifies Pharmaceutical Cartoning
Worker holding tablet displaying supply room inventory dashboard with charts in front of blue storage bins
Package Design
What Autonomous Supply Rooms Mean for Healthcare Packaging
3D printer setup with supply bottles and industrial equipment on red platform
Package Development
Designing the Convenience of Tamper Evidence
Products
Cagic industrial sorting and processing machine with control panel and conveyor system
AI-enabled X-ray Inspection Software Platform
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Induction Sealing Gap System
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Laboratory technician in sterile protective gear holding a clear glass vial for sample analysis
Robotics/Automation
Market Snapshot: Life Sciences Manufacturing
Pharmaceutical manufacturing assembly line with blue and white vaccine storage boxes and vials on conveyor system
Robotics/Automation
Automation Success on the Line
Healthcare professionals discussing pharmaceutical technology with medical storage equipment and digital analytics interface displayed
Labeling/Printing
Beyond the Label: Rethinking Healthcare Packaging
Elderberry & Honey Tonic bottle surrounded by dried flowers in white bowl on grass
Package Design
Package Design Ideas Transforming Wellness, OTC, and Healthcare Brands
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