Due to the sensitive nature of pharmaceutical and biochemical products, manufacturers and distributors are under pressure to keep these products within their recommended temperature levels. Failure to do so can result in loss of profit and even reputation.

A lot of things can happen while transporting these products from the manufacturing plant to the distribution channels. As such, it is imperative to fully analyse the whole delivery process to ensure that the products are kept in optimal conditions.

The goal of cold chain validation is to ensure that the right temperature is maintained through the use of appropriate equipment, packaging and distribution procedures. In this process, the products are subjected to worst-case scenarios to ensure that the products reach their destination whatever the conditions may be. Among the processes used for this type of validation are temperature mapping and monitoring using temperature data loggers.

Among the key deliverables of a validation are documents that will allow the organisation to develop protocols and a contingency plan.

Despite an organisation’s best efforts to ensure the seamless transportation of its products, a lot of things can happen between points A and B — from adverse weather conditions, to human error, to mechanical failure.

In crafting a Plan B, it is crucial to take into account every possible scenario that can happen and determine the possible consequences of every mishap at each stage of the delivery process. Once these have been taken into account, the next crucial step is to determine alternative measures that can be put into place to return the delivery back into track. These measures may include those pertaining to recovery or provision of assistance to personnel. Note that such strategies will vary depending on the type of products handled as well as the mode of transportation used. Of course, development and actual implementation of this contingency plan is never sufficient. Organisations should continuously review this plan and modify it should new potential problems be identified or changes within the delivery process be implemented.

What should a suitable contingency plan contain?

Again, each contingency plan will vary from one organisation to another. In general, a good one should contain contact information of important personnel, employees who should be informed of any, major temperature variations within a facility (eg due to power outage or extreme weather conditions) or delays in the delivery process, and the documents related to validated processes. It should also contain the appropriate measures to be implemented for product evaluation as well as available back-up transportation. Finally, it should also contain the appropriate steps that need to be undertaken should the product expire or perish before reaching its intended destination.

If you require help with your cold chain validation – please contact us.

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