Flowers or Chocolate - Quantifying Business Value

choice.jpg.jpeg ...When it comes to healthcare shipping in particular, many factors need to be considered while looking for packaging solutions, such as reliability, cost, reusability, technical features or quality aspects. Critical healthcare commodities will be placed in packaging solutions during transportation. Shippers need to compare alternatives in the large portfolio of niche transportation solutions available in the market place...

Risky Business

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This year the Food and Drug Administration (FDA) issued a report titled “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach” (cGMP stands for Current Good Manufacturing Practices). The Medicines and Healthcare products Regulatory Agency (MHRA), the equivalent of the FDA in the United Kingdom, has long adopted a risk-based inspection strategy. A risk corresponds to the possibility that a function, a procedure or a product does not perform as expected. Risk management programs consist of activities and actions to control risks. References on risk management for the healthcare industry are widely available...

A Hot Topic: Innovative Aircraft Temperature Controls

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Pharmaceuticals and biotechnological products are often produced in one region of the world and sold in another.

As these products move across continents by ocean or air, their quality depends on the reliability of the selected shipping company and mode of transport. An international flight may last up to 14 hours or more (including ground time at transit points), and many shippers are unclear about the environmental conditions shipments may experience during a long-haul flight. Thermal mapping recommendations are typically made with refrigerated storage areas in mind. Aircraft manufacturers are known to test temperatures on empty cargo holds, but data remains too often proprietary and undisclosed to customers.

FedEx Express took a scientific approach towards aircraft thermal mapping about two years ago...

FedEx Qualified!

direction1.jpg.jpeg Healthcare shippers, including pharmaceutical, biotechnological, medical device, equipment and diagnostics companies carefully select their transportation providers. Obviously, pricing, reputation, reliability, expertise and infrastructure have always played an important role in selection decisions.

In the last couple of years, however, many healthcare companies have established tighter internal procedures for assessing their vendors, including suppliers of services. Among quality professionals this assessment is known as “qualifying vendors”. Despite continued restructuring efforts in the healthcare industry, quality departments across the United States have experienced rapid growth due to the increasing importance of quality issues.

What you always wanted to know about Good Distribution Practices (GDP), but did not dare to ask.

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On March 7th of this year, the European Union issued new guidelines on Good Distribution Practices (GDP) that will take effect in 6 months. An updated version of original guidelines from 1994 was released in 2011 for public consultation. The extensive input of numerous stakeholders led to the new publication focused on medicinal products for human use. Contents do not contain any surprises for professionals who followed developments at cold chain conferences in particular.