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Regulatory: Page 35

Materials
FDA Announces New Inspection Protocol Project
For sterile injectable drugs, NIPP is reported as the first in a planned series of new inspection protocols covering all dosage forms. Agency’s goal is for full implementation within two years.
November 9, 2018
FDA Announces New Inspection Protocol Project
Supply Chain
CTI: Dual-Indicator Inks to Reduce Product Tampering and Counterfeiting
New ‘Tamper Heat’ and ‘Tamper Freeze’ inks combat product tampering from using extreme heat or cold to alter packaging.
November 9, 2018
CTI: Dual-Indicator Inks to Reduce Product Tampering and Counterfeiting
Pharmaceuticals
Live From FutureLink 2018: Digital Connectivity and the Supply Chain
FutureLink 2018 focuses on patients at the point of care, identifying how technology and information sharing networks are beginning to transform the digital life sciences supply chain.
November 7, 2018
During a panel discussion at FutureLink 2018, participants spoke about a need for greater education on serialization.
Supply Chain
Verification Router Service Moves from Theoretical to Practical
Work advances on look-up directories and testing. Live poll results show that most manufacturers plan to respond to requests using a solution provider participating in a VRS network.
November 6, 2018
VRS network
Labeling/Printing
‘Helper Code’ Aids Serialization
A serialization solution at Xttrium Laboratories for a new line dedicated to 16-oz PET bottles of mouthwash includes an ink-jet-printed ‘helper code’ printed ahead of case packing.
November 5, 2018
A 'helper code' makes it possible to create a parent-child relationship between the corrugated case and the 12 bottles inside.
Labeling/Printing
Serialization via P-S Label
Xttrium Laboratories sought a comprehensive serialization solution for a new line dedicated to 16-oz PET bottles of mouthwash. Print-and-apply laser technology plays a key role.
October 31, 2018
Each unwind stand on the Quadrel labeler has a Domino laser printer.
Adherence/Delivery
New Opioid Crisis Law Cites Unit-Dose Packaging
President signs Support for Patients and Communities Act into law; HCPC applauds efforts of Congress and the FDA.
October 26, 2018
New Opioid Crisis Law Cites Unit-Dose Packaging
Regulatory
Tobacco Pushes to the Front of the Line
A latecomer to FDA’s stable of responsibilities, regulation of tobacco aims to protect the public health, though these efforts are not without controversy.
October 26, 2018
Eric F. Greenberg
Materials
Schreiner MediPharm: Label for Dosing Syringe
Protective label is for a syringe system developed by Raumedic that supports exact dosage measurement of a medicine for children as part of a clinical trial.
October 26, 2018
Schreiner MediPharm: Label for Dosing Syringe
Pharmaceuticals
Novartis Subsidiary Salutas Pharma Completing Serialization Project
Salutas Pharma GmbH and its Polish affiliate LEK S.A. have upgraded 47 production lines within a year as part of its effort to implement and adhere to the European Union Falsified Medicines Directive.
October 25, 2018
Kay Reinhardt, Team Leader Engineering Projects, managed the upgrade of 26 packaging machines at Salutas Pharma. (Uhlmann photo)
Labeling/Printing
Automated Packaging Systems: Bag Printer Additions
AutoLabel 500 and AutoLabel 600 thermal-transfer printers provide fast, accurate inline printing, and work in tracking and compliance applications.
October 22, 2018
Automated Packaging Systems: Bag Printer Additions
Pharmaceuticals
HDA Survey Indicates DSCSA Readiness Progress
With the Nov. 27, 2018 milestone almost here, respondents indicate concerns, including CMO knowledge, delayed equipment deliveries, and meeting 2019 saleable returns requirements.
October 19, 2018
HDA Survey Indicates DSCSA Readiness Progress
Previous Page
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Top Stories
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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Robotics/Automation
Market Snapshot: Life Sciences Manufacturing
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Robotics/Automation
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