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402 Results
Type: Article
Section: Industry News > Regulatory
Regulatory
OPTEL Obtains End-to-End Traceability via Verify Brands
OPTEL GROUP has announced it is expanding its traceability offering through the acquisition of Verify Brand.​
December 7, 2017
OPTEL Obtains End-to-End Traceability via Verify Brands
Pharmaceuticals
Spanish Firm Adds Serialization
Normon Laboratories complies with EU FMD serialization regulations with TraceLink system to ensure patient safety.
November 6, 2017
Normon Laboratories Selects complies with EU FMD serialization regulations with TraceLink system to ensure patient safety.
Medical Device/Packaging
FDA Addresses Medical Device Manufacturing Recovery in Puerto Rico
FDA issues statement on the medical device manufacturing recovery in Puerto Rico following the infrastructure devastation from Hurricanes Irma and Maria.
October 23, 2017
FDA Commissioner Scott Gottlieb, MD
Traceability/Serialization
Cutting Through the DSCSA Confusion
How to read the regs to be sure you’re in compliance come December 2018, and how to know which rules will apply to you in different circumstances.
October 19, 2017
Companies' acting roles under the DSCSA regulations
Pharmaceuticals
‘60 Minutes’ Takes Aim at the Pharmaceutical Industry in Opioid Epidemic
Oct. 15 episode interviews “whistleblower” Joe Rannazzisi, former DEA Deputy Assistant Administrator, who accuses distributors of “fueling the opioid epidemic by turning a blind eye to pain pills being diverted for illicit use.”
October 18, 2017
Oct. 15 episode interviews “whistleblower” Joe Rannazisi, former DEA Deputy Assistant Administrator, who accuses distributors of “fueling the opioid epidemic by turning a blind eye to pain pills being diverted for illicit use.”
Medical Device/Packaging
Q&A Part 2: EU’s Medical Device Regulation
Questions still linger about the EU's MDR and its effects on packaging. Experts talk timing and packaging innovation.
October 4, 2017
Kelli Anderson, M.S., VP Client Solutions at Network Partners
Regulatory
Q&A Part 1: EU’s Medical Device Regulation
Questions still linger about the EU's MDR and its effects on packaging. What challenges lie ahead?
September 21, 2017
Questions still linger about the EU's MDR and its effects on packaging. What challenges lie ahead?
Regulatory
FDA Issues Hurricane Safety Resources for Packaged Meds, Food and Water
Uncertain about the safety of your packaged food, water, or medications in the wake of hurricane damage? These agency resources offer assistance.
September 12, 2017
Uncertain about the safety of your packaged food, water, or medications in the wake of hurricane damage? These FDA resources offer assistance.
Pharmaceuticals
Pharmaceutical Industry Presses Forward with Serialization Strategies
Despite FDA’s recent one-year enforcement delay, the pharmaceutical community strives to meet the unchanged Nov. 27, 2017 DSCSA compliance deadline.
September 7, 2017
Although Nov. 27, 2017 remains the deadline for DSCSA compliance, the FDA announced a one-year delay in enforcement to Nov. 26, 2018 for manufacturers to affix or imprint product identifiers to each package or homogenous case of product intended to be introduced into commerce.
Regulatory
Top five forces shaping life sciences in the future--#1 Regulations: A Top-of-Mind Concern
New white paper from PMMI Business Intelligence outlines the top five forces shaping the pharmaceutical and medical device markets. Regulatory compliance drives all conversations.
August 22, 2017
#1 Regulations: A Top-of-Mind Concern
Regulatory
Hongyang Biotechnology Partnership Provides Authentication Security
TruTag’s authentication security platform aims to protect livestock—beginning with pigs—at some 1,500 farms in Hongyang’s supply chain in China.
August 16, 2017
TruTag’s authentication security platform aims to protect livestock—beginning with pigs—at some 1,500 farms in Hongyang’s supply chain in China.
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.
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.
Pharmaceuticals
Customization Key to Anti-Counterfeiting and Security
Employing overt, covert and forensic security labels to remain in front of counterfeiters, would-be tampering efforts and/or theft.
July 17, 2017
Void and holographic labels provide both tamper evidence and make it difficult to counterfeit a product.
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.
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.
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