September 21, 2011 - Cold Chain Design for Frozen Products
More and more pharmaceutical companies are losing favor with dry ice as a refrigerant. This article discusses why as well as three steps which are key to the design of a successful cold chain packing configuration for frozen products. An article exclusive to ColdChainInfo.com by Scott Dyvig.
June 25, 2011 - An Introduction to Cold Chain Regulations, Guidances and Standards
Negotiating the many facets of storage and distribution of temperature controlled or cold chain products can be a difficult task. When dealing with products that not only hold significant monetary value but are also critical components to the quality of human life, the stakes are high. There are numerous companies, products, regulations, conferences and opinions available that can be helpful in finding ways to approach cold chain management. This article will attempt to provide a brief summary of the various documents and organizations that are shaping this critical industry. An article exclusive to ColdChainInfo.com by Jeff Wodrich.
May 31, 2011 - Design Considerations for Dry Ice Shippers
Shipping temperature-sensitive products using dry ice can seem deceptively simple. It is not enough to place your product into a cardboard box and cover it with dry ice. In this example you can see a few of the design considerations for dry ice shippers. An article exclusive to ColdChainInfo.com by Scott Dyvig.
March 1, 2011 - USP Readies Storage and Transport Guidance
The guidance is intended for use by all parties in the supply chain.
After three years of work and extensive input from industry, FDA, and regulatory bodies globally, the United States Pharmacopeia Packaging, Storage, and Distribution Expert Committee (PSD EC) has completed work on USP General Chapter <1079>, Good Storage and Transportation Practices For Drug Products. Courtesy of PMPNews.com.
August 31, 2010 - Getting to Grips with Stability Testing and Regulatory Compliance
Find out more about the challenges in pre-and post-release stability testing and formulation. In this Pharma IQ interview, Claire Willsher, head of analytical development at Lifecycle Pharma, discusses the technologies being employed by Lifecycle Pharma to pre-empt these challenges. Willsher also offers her perspective on Quality by Design, cost-cutting and how to achieve regulatory compliance. Courtesy of Pharma-iq.com.
June 1, 2010 - Saving Money on Cold Chain Transport
Pharmaceutical and biotechnology manufacturers can save
money on cold chain transport through reusable solutions
and closed-loop or reverse logistics programs.
April 26, 2010 - Maximizing Confidence in Temperature-Controlled Pharmaceutical Shipping
(pdf whitepaper courtesy of American Airlines Cargo)
April 16, 2010 - How to avoid and respond to FDA 483 letters
The 10-step guide is designed to help pharmaceutical processors, blood and tissue banks, clinical laboratories, medical device manufacturers, research hospitals, and other GxP facilities that may receive public criticism warning letters respond quickly and appropriately within the permitted 15-day window. Proper FDA 483 letter response is critical to both help in reputation repair and for remediation actions to assure a quality process and patient safety.
April 16, 2010 - 10 Reasons to Add Reusability to Your Thermal Shipping Container
Article supplied by Minnesota Thermal Science to HealthcarePackaging.com.
March 2010 - Recognizing Pharma Cold Chain Excellence
Three years ago, IQPC inaugurated a peer-reviewed Cool Chain Excellence Awards program at its annual Cool Chain Europe conference to bolster attendance and nurture participation in their event by highlighting key achievements made within the pharmaceutical cold chain industry, which personified industry best practices. Since its inception in 2008, the number of nominations has more than doubled year-over-year, with the 2010 Cool Chain Excellence Awards drawing nearly 20 enthusiastic nominations worldwide across three distinct categories.