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402 Results
Type: Article
Section: Industry News > Regulatory
Supply Chain
Shippers Deliver Early-Stage Clinical Trial Samples
Celerion helps its pharmaceutical manufacturer clients safely and swiftly deliver products in environmentally friendly, temperature-sensitive shipping containers.
November 28, 2018
Celerion uses shippers like this to deliver early-state clinical trial samples.
Robotics/Automation
Fitting Track and Trace into a Patient-First Culture
Catalent’s Bloomington, IN facility meets U.S. and European regulatory deadlines via a turnkey approach on a vial and syringe packaging suite.
November 12, 2018
Catalent’s Bloomington facility serializes and aggregates vials and syringes.
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 responsibilities in an effort to prevent confusion throughout the supply chain.
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.
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)
Pharmaceuticals
Pineberry Partners on Pharmaceutical Serialization, Aggregation
Company displays its CartonTrac FC (Flat Carton) serialization system that’s incorporated with Adents’ Pharma Suite serialization software.
October 14, 2018
Pineberry Manufacturing’s CartonTrac serialization and aggregation system.
Pharmaceuticals
Aggregation System Creates Parent-Child Relationship
Pharmaceutical firm employs supply chain serialization/aggregation with automated product track-and-trace abilities.
September 26, 2018
In this aggregation step, finished, coded cartons are ready for shipping.
Pharmaceuticals
Pharmaceuticals: The Bad, the Good, and the Ugly
Although mix-ups in labeling and filling lead to recalls, packaging deserves credit for improving patient outcomes.
September 6, 2018
Although mix-ups in labeling and filling lead to recalls, packaging deserves credit for improving patient outcomes.
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
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, discusses UDI implementation during AHRMM 2018 in Chicago.
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.)
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.
Pharmaceuticals
Contamination Prompts Voluntary Valsartan Recall
Manufacturing changes at China facility believed to be the source of the NDMA impurity—an issue that could trace back to 2012.
July 26, 2018
Manufacturing changes at China facility believed to be the source of the NDMA impurity—an issue that could trace back to 2012
Pharmaceuticals
Johnson & Johnson Supply Chain (JJSC) Employs Global Serialization Strategy
With a heritage of 130+ years of helping people live longer lives, JJSC’s serialization/traceability efforts focus on safely delivering medicines to healthcare providers and patients worldwide.
July 5, 2018
Carton serialization is part of J&J’s strategy to meet global regulatory demands.
Traceability/Serialization
Serialization Trends: 6 Mixed Emotions
From hospital traceability and blockchain use cases to Europe’s FMD readiness, speakers at the Adents Serialization Innovation Summit offered perspective on what’s happening now and what to “look forward” to.
June 26, 2018
Tianna Umann, Cross Domain Solution Architect at Microsoft, explained that there are multiple types of blockchain (and trust levels).
Regulatory
Serialization a Key Focus in Developing Regions
Manufacturers face global challenges implementing serialization standards, according to a report by PMMI Business Intelligence.
June 22, 2018
Serialization a key focus in developing regions
Pharmaceuticals
DSCSA Enforcement Readiness: Check
Pharmaceutical contract packager Reed-Lane works with consulting firm, machinery vendors on three key packaging lines to meet fast-approaching serialization enforcement deadline.
June 14, 2018
Inspecting data on printed labels for application to bottles.
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