Annegret Blum, Director, Principal Consultant Quality Management and Compliance, at PharmaLex
The transport of medicinal products poses a large number of external risk factors to product quality, with one of the most costly issues being temperature deviations. To address these concerns, the EU good distribution practices (GDP) guidelines request a transport risk assessment focused on temperature during transport as a critical factor.
The outcome of the risk assessment will facilitate decision-making regarding the implementation of temperature controls, as well as, where required for the product, other factors such as moisture, light, vibration and air pressure.
The first step with a risk assessment should be the development of an initial, high-level transport mapping, describing the transport from the storage facility at start of the journey to the storage facility of the final recipient. The mapping should show intermediate storage facilities, modes of transport, transits, climatic zones and a rough estimate of timelines. A grouping of products with comparable product characteristics, stability and delivery routes and/or the determination of few worst-case scenarios may reduce the number and complexity of risk assessments to be performed.
The mapping can be fine-tuned with additional information, such as vehicle types, intermediate hubs, further transits, holding times, information on environmental factors, established controls or monitoring of environmental factors, more detailed timelines and so on.
Risk assessment methods such as a failure mode and effective analysis approach (FEMA) correlates the severity of potential failures with the probability of occurrence and the probability of detection.
This detailed transport mapping facilitates the risk assessment, after which risk mitigation or minimization measures should be put in place, where needed. Questions to consider should include: Is it possible to reduce transport time and/or holding times? Can the number and duration of transits be reduced, for example by changing the mode of transport, interim storage, reloading, etc.? Can the shipping containers be improved? Do additional temperature controls (or other controls) need to be implemented?
Nevertheless, some risks can’t be managed by risk minimization strategies and then it’s important to decide whether those risks, and the resulting consequences, can be accepted or not.
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