Advanced Degrees,Outside the Box

Whether you plan to utilize active or passive packaging systems for transporting your time- and temperature-sensitive healthcare products, there are certain aspects to qualifying the process that are essential. Some are obvious, while others are easily and repeatedly overlooked. It is no longer just about package performance. It extends beyond testing materials and components for suitability, cost considerations and implementation, to include understanding your product, your distribution network, your suppliers’ capabilities and limitations, training, and monitoring the distribution system for changes. It’s a sophisticated, dynamic, and challenging process. And as the principles of qualifying the transport and distribution of time- and temperature-sensitive healthcare products continues to closely follow established guidelines and regulation for qualifying their manufacture, regulatory authorities the world over continue to increase their knowledge as well as their expectations regarding the transport and distribution of these articles. Having a thorough and well-documented process is key to having confidence in the performance of your packaging and crucial to surviving an eventual regulatory audit.

There are a number of guidance documents within the industry that are considered best practice documents for the storage, transport and distribution of time- and temperature-sensitive healthcare products, and a list of the most commonly referenced documents is included at the end of this article. The level of familiarity, knowledge and application of these guidances throughout the industry is very broad indeed. No one document addresses it all, but among them they capture the following considerations for validating temperature-controlled shipping systems within the pharmaceutical market.