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Logistics & cold chain packaging: Page 73

Supply Chain
Reevaluating drug product stability can save millions on packaging
Kevin O’Donnell, Senior Partner, Exelsius, is a noted authority in supply chain integrity. In this Q&A he lends his “big-picture” insights regarding distribution practices for time and temperature-sensitive pharmaceutical/biological products.
September 29, 2014
Kevin O’Donnell, Senior Partner, Exelsius, is a noted authority in supply chain integrity.
Materials
Changes made to EU Guidelines for GMPs
Chapter 5, sections 17 to 21 revisions provide guidance that aims to help prevent cross-contamination and benefit supply chain traceability.
September 24, 2014
Robotics/Automation
Contemporary Graphic Solutions: Online compliance and productivity
Software services suite handles design, print, and packaging product life cycle aspects to increase efficiencies and financial savings.
September 23, 2014
Pharmaceuticals
Guideline delineates how to implement GS1 standards
Document provides intelligence to support pharmaceutical lot-level management and future item-level traceability requirements
September 17, 2014
GS1 US published a guideline on how to implement GS1 Standards to support 2013 DSCSA. Photo is for illustration purposes only
Inspection
Immobilized plant cells: from DSMZ to the customer
VisiSens technology is used to detect metabolic activities of immobilized plant cells during simulated cell transport in a closed system.
September 16, 2014
FIGURE 1: Experimental set-up: Monitoring set-up in the lab showing three VisiSens detection units.
Materials
FDA’s growing global focus faces language barriers
As FDA becomes more globally focused, drug complaints and adverse event reporting pose “cultural” challenges, as do inspections.
September 11, 2014
FDA’s growing global focus faces language barriers
Materials
PDA developing Technical Report on drug shortages
Parenteral Drug Assn. expects to publish report on the prevention and management of drug shortages by early 2015.
September 10, 2014
PDA developing Technical Report on drug shortages
Inspection
Onset: Temperature data logger
HOBO MX1101 transmits temperature and relative humidity data to mobile devices via Bluetooth Smart.
September 8, 2014
Onset: Temperature data logger
Materials
USP to roll out information chapters on Good Distribution Practices
Five new general chapter standards related to GDP to become official next year, when three new chapters will be proposed.
September 8, 2014
Desmond Hunt, Ph.D., Senior Scientific Liaison, U.S. Pharmacopeial Convention (USP)
Materials
'Explosive growth' projected for cold chain logistics services
Events in Boston and Frankfurt, Germany to reveal late-breaking developments in temperature-controlled packaging, distribution, and logistics.
September 5, 2014
'Explosive growth' projected for cold chain logistic services
Labeling/Printing
The case for and against RFID in pharma
Reaching necessary read accuracies remains a challenge in pharmaceuticals, but RFID could still prove useful.
August 29, 2014
Dirk Rodgers, who contributed to Healthcare Packaging’s Pharmaceutical Serialization Playbook, is founder of RxTrace.
Pharmaceuticals
'Cold Chain Chronicles' delivers thought-provoking insights
New book authored by Kevin O’Donnell provides practitioner’s outside-the-box perspectives on the importance of temperature-sensitive drug stewardship.
August 18, 2014
'Cold Chain Chronicles' delivers thought-provoking insights
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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.
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