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402 Results
Type: Article
Section: Industry News > Regulatory
Regulatory
Counterfeiting Results in DQSA Legislation Headaches
Drug counterfeiting used to include primarily ‘lifestyle drugs’ such as Viagra, but now fraudulent lifesaving drugs are increasingly being produced, putting the health of more at-risk patients on the line.
June 8, 2018
Counterfeiting Results in DQSA Legislation Headaches
Regulatory
The Best $200 You’re Not Spending on Brand Protection
Registering your trademark and copyright with Customs and Border Protection can help expedite the seizure of counterfeit drugs, alerting you to the product in question and where it’s headed.
May 29, 2018
Registering your trademark and copyright with Customs and Border Protection can help expedite the seizure of counterfeit drugs, alerting you to the product in question and where it’s headed.
Traceability/Serialization
CPO Maintains Tailored Approach Adding Level 5 Serialization System
allpack offers customers greater flexibility and scale with a cloud-based system that maintains customer focus while managing and exchanging data for serialization compliance.
May 10, 2018
Independent contract packaging organization (CPO) allpack focuses solely on the pharmaceutical sector, offering clinical and commercial packaging services ranging from small volume to large lot sizes.
Pharmaceuticals
Smart Pharmaceutical Packaging Demand Poised for Growth
The integration of NFC technologies into pharmaceutical applications, such as time-temperature indicator labels, is among the cutting-edge technologies Smithers Pira identifies as pushing brand owners toward intelligent packaging.
May 7, 2018
The integration of NFC technologies into pharmaceutical applications, such as time-temperature indicator labels, is among the cutting-edge technologies Smithers Pira identifies as pushing brand owners toward intelligent packaging.
Traceability/Serialization
Of Trees and Traceability
Intelligent supply chains have the potential to improve efficiency at the natural resource level and create opportunity for OEMs. Can people look beyond the next fiscal quarter?
May 2, 2018
The ability to trace and sort raw materials can allow for items of specific quality go to the transformers (manufacturers) who need that level of quality, ultimately reducing waste.
Regulatory
Data Integrity Code of Conduct
While the FDA asks pharma companies to heed its warnings around good manufacturing practices, the Parenteral Drug Association outlines actions to take.
April 27, 2018
Els Poff, Executive Director of the Data Integrity Center of Excellence at Merck
Pharmaceuticals
Examining the Properties of TIJ Fluids and Their Role in Serialization
Editor’s note: Part I of a two-part series addresses issues pertaining to the color fastness of CIJ ink.
April 26, 2018
Domino has developed several inks, including this BK640 ink cartridge, for 2D coding.
Nutraceuticals/Dietary
Packaging Protects Products from the Inside-Out
Melbourne-based Swisse Wellness employs a desiccant and a scannable label to protect and authenticate its growing portfolio of products worldwide.
April 20, 2018
Melbourne-based Swisse Wellness employs a desiccant and a scannable label to protect and authenticate its growing portfolio of products worldwide.
Medical Device/Packaging
How to Address Medical Device Cyber Attacks
Connected med devices offer great promise for users and healthcare providers. But with the increasing risks of cyber attacks, here are some key activities and standards for device manufacturers.
April 11, 2018
Connected med devices offer great promise for users and healthcare providers. But with the increasing risks of cyber attacks, here are some key activities and standards for device manufacturers. (Image credit: (c) Can Stock Photo / kentoh)
Pharmaceuticals
Track-and-Trace System Employed by Desitin in Germany
Mid-sized pharmaceutical firm uses PAS-X Track & Trace on two of its packaging lines in Hamburg to comply with anti-counterfeiting requirements.
April 4, 2018
Mid-sized pharmaceutical firm uses PAS-X Track & Trace on two of its packaging lines in Hamburg to comply with anti-counterfeiting requirements.
Supply Chain
Supply Chains Struggle to Utilize Digitalization Technologies
DHL’s new research indicates businesses are resisting technology despite its ability to reduce cost and improve profitability, which could leave theme at risk of being left behind.
March 6, 2018
DHL’s new research indicates businesses are resisting technology despite its ability to reduce cost and improve profitability, which could leave theme at risk of being left behind.
Pharmaceuticals
Coating Technology Resolves Serialization Issue
Platinum Press works with its suppliers to eliminate a problem customers had experienced with serialized codes rubbing off booklet-style labels.
February 21, 2018
Akorn partnered with Platinum Press to produce readable, serialized labels, as shown in this rendered image.
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
A VRS could be used to manage acceptance, formatting and delivery of requests/responses to support DSCSA verification requirements (Credit: HDA)
Traceability/Serialization
Part 2: Making Use of Serialization Data
An information expert from Merck shares advice on how data can be used, what challenges should be overcome, and what may be in store in the future.
January 22, 2018
Consumer interaction through scanning could provide significant benefit, with the right practices to ensure data and identities are secure and HIPPA-compliant.
Traceability/Serialization
Part 1: Making Use of Serialization Data
An information expert from Merck shares advice on how data can be used, challenges to overcome, and what may be in store in the future.
January 17, 2018
Michele D'Alessandro, Vice President and CIO for the Manufacturing Division at Merck.
Labeling/Printing
Device Company Streamlines Global Labeling Process
For neuroendovascular technology company MicroVention, SQL script decreases production labor hours while the GS1 Wizard helps meet UDI standards.
January 9, 2018
MicroVention, an Aliso Viejo, CA-based medical device company specializing in neuroendovascular technologies, operates facilities internationally.
Pharmaceuticals
Is Pharma Overlooking Aggregation?
Contract manufacturing organization PCI Pharma Services assesses serialization and aggregation, partnering with key vendors to address issues ranging from OEE to ink leachability.
December 14, 2017
Bottle serialization code inspection line of site is in the horizontal direction here, suggesting a need for a helper code on the top or bottom of the bottles.
Pharmaceuticals
Nordic Group Takes on Large-Scale Serialization Program
European pharmaceutical company partners with Supply Chain Wizard to implement serialization across multiple lines to meet U.S. and EU regs.
December 12, 2017
European pharmaceutical company partners with Supply Chain Wizard to implement serialization across multiple lines to meet U.S. and EU regs.
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