Training: Why It's Important

Training Keeps the Supply Chain Healthy

It has been apparent for some time that more robust training is needed around the transport aspect of pharmaceutical distribution – specifically the risks associated with the different modes and how to mitigate them successfully.

During distribution (especially international distribution), we potentially rely heavily on so many different external partners to follow adhere to their own quality and handling procedures to achieve our goal :- the highest level of process-controlled distribution possible.

Despite our reliance on these partners, the most essential step in the supply chain when it comes to risk mitigation is at origin, the actions we take, the instructions we give, and the level of understanding of the supply chain, all of which feed into the end goal; maintaining the efficacy of a medicinal product to ensure patient safety. This can only be done with appropriate and approved GDP training.

We do NOT want to be dispensing chemotherapy to a patient with only 65% clinical efficacy due to a temperature excursion which occurred for no reason other than lack of training somewhere in the legal supply chain.

Almost all of us have received medicines from the pharmacy, or in hospital at some point in our lives, more often more than once. Only around a quarter of the medicines dispensed in the UK are manufactured here, which means that the other three quarters have bypassed continents, climates, and cultures to get here via different modes of transport.

How do we guarantee those medicines haven’t been exposed to critical factors that affect their stability, such as light, temperature, and humidity?

How do we ensure the medicines have remained within the legal pharmaceutical supply chain, and we aren’t receiving a cleverly packaged counterfeit, or falsified medicine instead?

Being sure of what you work for...

Most of you reading this blog will already be in the industry of manufacturing, wholesaling, pharmacy, and consulting.

- Ask yourself, do you fully understand the steps involved during pharmaceutical distribution?
- Do you know what paperwork is required for export and Import?
- Do you know what information your distribution partners need to mitigate risk?

Not only do YOU have a role to play in risk mitigation, but each of your partners do too, and their risk mitigation strategy relies on the quality of information you give them, whether that’s during supplier onboarding, SOP creation or simply at the point of booking a transport job.

Don't be concerned about the idea of physically visiting and personally auditing your receiving customer or supplying wholesaler. They have the same right to audit you, but this is an excellent way of making sure everyone is in compliance to the GDP regulations, and this includes current and up-to-date training.
If as an RP or management you cannot provide tangible evidence that your staff has received quality training, it is a serious situation:
The inspector from the UK competent authority (the MHRA) could tell you to suspend all activities until the entire staff have received training. Not only is this an expensive situation, it's also a deeply embarrassing one too.

Test Yourself

Some more questions to test your current level of understanding (just a taster to get the brain sizzling):

- What information do you think a forwarder needs to successfully arrange a pharmaceutical shipment?
- Can you complete a route risk assessment successfully, considering the different distribution partners and their differing global capabilities?
- What is the end goal of lane validation and route risk assessment?
- How do you ensure the results of the route risk assessments bring value? (e.ge.g., not a desktop exercise).
- What risks are associated with air cargo transportation and how are these mitigated?
- What risks are associated with ocean cargo transportation and how are these mitigated?
- What risks are associated with road transportation and how are these mitigated?

- Have you noticed that the highest contributing risk factor is different throughout all modes?
- What paperwork is mandatory when importing and exporting pharmaceutical products?
- What steps are involved in the international supply chain? Can you map them for all transport modes?

If you answer NO to any of the above, you will massively benefit from some further training.

Assistance and Support

If you need help, we can offer a free over-the-phone initial consultation on 0330 133 0920 or you can email us on info@ukgdpassociation.co.uk.

Alternatively, use the contact form at the top right of this screen.