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MHRA GDP Symposium

Having attended a very informative MHRA GDP Symposium, we thought we would share some of the take-home messages relevant to temperature monitoring and control. Alan Bentley (GDP Inspector, MHRA) gave a practical presentation on Chapter 9 of the EU guidelines, aptly titled ‘Around the world in 80 ways’.

Alan emphasised that the responsibility to ensure that temperature conditions are maintained within acceptable limits during transport lies with the supplying wholesale distributor. Key to management of these responsibilities is a clear understanding of your transport process. It is also essential to have a clear understanding and agreement of all stakeholders’ responsibilities within the process. Technical agreements should be in place with critical third party service providers.

Topics discussed in his presentation included assessing the suitability of vehicles, use of dedicated vehicles and the assessment of deviations during transport.

Alan endorsed the use of risk assessment tools to establish whether there is a need for temperature control in your transport chain.

Some temperature-related considerations in carrying out such an assessment may include:

  • Temperature mapping of transport chain
  • Consideration of temperatures in emergency and out of hours deliveries
  • Temperatures at transportation hubs
  • Selecting shipping containers – include qualification and labelling

A number of workshops were held, working through specific scenarios, serving to illustrate how important transit temperatures are and to share delegate knowledge on the management of deviations in the transport chain.

As delegates, the clear message from the MHRA is that temperatures in transit are critical, and that there is an expectation that risk assessment is carried out on your transport process to establish control.

If you wish to discuss any of the above topics, or wish to carry out temperature mapping on your transport chain, give Claire a call on 01-4666952.


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