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402 Results
Type: Article
Section: Industry News > Regulatory
Packaging/Filling
Sharp Packaging to gain 10-month ROI on tablet counter
A successful validation study leads to a pharmaceutical contract packager’s use of tablet counters on all its bottling lines and small-quantity bottle filling.
June 17, 2014
Labeling/Printing
When it comes to serialization, start now
A seminar held during interpack by Optel and Domino emphasizes the urgency of developing a serialization strategy now, and addresses the challenges of implementation.
May 27, 2014
Materials
Voice of the experts: Controlled room temperature packaging considerations
Healthcare Packaging (HCP) speaks with Mark Davis, UPS Healthcare Logistics Manager, who specializes in temperature-sensitive solutions, about packaging and shipping temperature-sensitive products.
April 23, 2014
Pharmaceuticals
FDA wants pharma to move from compliance to quality
By establishing an Office of Pharmaceutical Quality, FDA hopes to spur pharmaceutical manufacturers to address batch process, packaging, and other problems impacting the supply chain.
April 11, 2014
Materials
The changing face of clinical trial services
A contract packager examines trends affecting the pharmaceutical industry.
March 12, 2014
Pharmaceuticals
Ghost watermark thwarts counterfeiters in cost-effective process; wins FPA honors
Technology employs a repeating watermark embedded in a flexible or semi-rigid package to address counterfeiting and help ensure brand protection.
March 5, 2014
Labeling/Printing
Lessons learned: On the packaging line
Here are actual lessons learned about what actually happens in the plant and on the line, from those who have conducted live supply chain pilot tests.
January 20, 2014
Robotics/Automation
Lessons learned: Project and vendor management
Here are some key lessons learned from those who have conducted live supply chain pilot tests. This article focuses on lessons learned about project and vendor management.
January 19, 2014
Supply Chain
How GS1 can help with pilot testing
GS1 US offers a 2105 Readiness Pilot program that offers a simple approach for initiating and managing pilots.
January 18, 2014
Labeling/Printing
Preflighting your supply chain pilot
Once you start shipping live product as part of a pilot test, it is not easy to revert back into test mode.
January 18, 2014
Pharmaceuticals
Getting started with pilot tests
Once you’ve identified your goals, you should start giving thought to selecting one or more sites, lines, SKUs, vendor technologies, and trading partners for your pilot test(s).
January 17, 2014
Pharmaceuticals
Avoid these EPCIS interoperability pitfalls
One of the greatest challenges facing the pharmaceutical supply chain is hooking up multiple ERP systems and business applications across the supply chain, spanning the manufacturer, contract packager, wholesaler/distributor, and pharmacies. Ensuring interoperability of the data across the supply chain is a challenge, even if all parties adopt GS1’s EPCIS standard.
January 12, 2014
Pharmaceuticals
Issues with master data
Trading partners with whom you exchange EPCIS event data will request what is known as “supply chain master data” about your products, company, and locations that will be referenced in EPCIS events. This data takes two basic forms.
January 11, 2014
Pharmaceuticals
Case study: Contract packager builds its own serialization solution
CMO/CPOs faced with a global client base, obligations to meet multiple and varied country regulations, and the insane complexity of integrating with multiple customers would do well to heed the story of Almac Pharma Services.
January 10, 2014
Pharmaceuticals
Five implementation tips for CMO/CPOs
One of the biggest challenges that CMO/CPOs will face when it comes to serializing their lines is how to sort through the complexity of integrating their internal serialization solution at the line and plant level with their customers’ business systems.
January 10, 2014
Pharmaceuticals
Determining goals and metrics for pilot testing
There are two schools of thought when it comes to pilot testing.
January 10, 2014
Traceability/Serialization
Contract manufacturing and contract packaging strategic considerations
It’s become a fact of life that the North American pharmaceutical industry, while still firmly rooted in manufacturing of its own products, also makes heavy use of outsourcing to contract manufacturing/contract packaging organizations.
January 8, 2014
Robotics/Automation
Line- and plant-level software implications
While GS1’s Electronic Product Code Information Services (EPCIS) protocol standardizes the way serialization data is transmitted between trading partners, there is no such standard for communicating between a company’s internal serialization solution and its Manufacturing Execution System (MES), Enterprise Resource Planning (ERP) systems such as SAP, and ERP modules that handle serial number management (such as Aii in the case of SAP). And therein lies the rub.
January 8, 2014
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