Regulatory: Page 38

Regulatory
Preparing for the China-U.S. Trade War
Tariffs ignite tension in the manufacturing industry. Here are some steps to take to offset the expense of new import/export duties.
August 21, 2018
Preparing for the China-U.S. Trade War
Pharmaceuticals
Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under a Serialization Regulation
Aggregation data is the only thing that will ease the burden of compliance for downstream trading partners in a serialized world, says RxTrace’s Dirk Rodgers.
August 21, 2018
View of a layer of pharmaceutical cartons inside a case. (Photo courtesy of Omega Design.)
Traceability/Serialization
Could Penny-Pinching on Labels Derail Your Serialization Investment?
Part II of a two-part series emphasizes the significance of labeling in serialization, aggregation, and in temperature-sensitive environments.
August 15, 2018
Supply chain infographic provided by Domino.
Medical Device/Packaging
Live from AHRMM: Taking a Patient Focus for UDI Implementation
August 13 panel discussion recognizes “everyone has a stake in a successful UDI implementation,” citing industry and patient benefits as incentives.
August 14, 2018
John Kelty, Director of Business Solutions, WL Gore and Associates.
Medical Device/Packaging
Providers Get The Message
Though its regulatory focus is usually on medical products and their makers and sellers, when the need arises, FDA writes letters to health care providers.
August 13, 2018
Eric F. Greenberg
Labeling/Printing
Acquire Automation: Tabletop Printing System
Q Series unit prints, inspects and accounts for all labels in a batch and is designed specifically for pharmaceutical and life science applications.
August 8, 2018
Acquire Automation: Tabletop Printing System
Pharmaceuticals
Turkish Pharmaceutical Firm Set to Meet FMD Compliance Deadline
Adbi Ibrahim is implementing pharmaceutical compliance management and serialization processing software to meet international requirements ahead of the 2019 deadline.
August 7, 2018
Abdi Ibrahim Esenyurt, Istanbul production complex. (Photo courtesy of Abdi Ibraham.)
Regulatory
Schreiner MediPharm: Covert-Hologram Seal for Tamper Protection
Irreversible holographic effect offers first-opening indication and tamper evidence, complying with the EU Falsified Medicines Directive.
August 6, 2018
SMP_Covert_Hologram-Seal
Labeling/Printing
Fox IV Technologies, Inc.: Label Printer/Applicator
New 5610 can print and apply a label directly from a PDF format, and be used as part of a pharmaceutical track-and-trace system.
August 3, 2018
Fox IV Technologies, Inc.: Label Printer/Applicator
Cannabis
California’s Cannabis Update: Beverages, Testing and More
The state of California experiences some pains this summer as the industry and regulations continue to evolve.
August 3, 2018
dispensary marijuana packaging
Pharmaceuticals
Pii Captures Lightning in a Serialized Bottle
Track-and-trace systems at Pharmaceutics International, Inc. integrate into its existing packaging lines, helping the CDMO become serialization-ready.
August 2, 2018
PCE label serialization kits produce serialized labels, which are inspected by a PCE smart camera.
Regulatory
Ignore Law's Definition of Drugs At Your Peril
FDA Warning Letters asserting that a supplement is a drug point up the curious legal definition of “drug” and provide a useful reminder to others.
July 30, 2018
Eric Greenberg
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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
At PACK EXPO, Eagle launches SimulTask 6, which offers food processors advanced image analysis, real-time production monitoring, automated reporting, and task-based inspection.
Integrated Water Insoluble Matter Testing Systems
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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