Validation versus Qualification in Shipping

pic2.jpg Many healthcare shippers ask us at FedEx Express whether our cold chain transportation solutions are validated.

Validation means that processes will lead to consistent, reproducible results under highly controlled environmental conditions. However, in the shipping industry, transportation providers cannot control every factor during transport due to external variables (weather, capacity constraints, mechanical failures, missed connections, clearance delays, etc.). So in transportation, we are really talking about qualification rather than validation, and while it is not possible to validate transportation processes, they can in fact be qualified...

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.