Top Tips for Effective Transport Validation

Effective Transport Validation: 10 Top Tips

Following on from our blog post relating to the “Transport Validation Exercises: A GDP Compliant Approach”, and as there are several elements of performing effective transport validation exercises, we thought it may be beneficial to share some hints and tips on how to get the most valuable information out of your transport validation exercises: 

1 – Start with a Risk Assessment 

Review your current transport provider and their services thoroughly and identify any critical elements of their service including routes, cross-docking, and seasonal changes that may pose risks to product integrity. 

2 – Define Acceptance Criteria 

Use your product range storage requirement limits as a guide and set temperature ranges, time limits, and other performance benchmarks that your transport method must meet.  

3 – Use Calibrated Data Loggers 

Ensure all monitoring devices are calibrated and certified to a National Standard before use. This is not only a regulatory requirement, but it also guarantees the accuracy of temperature and humidity data produced as part of your validation exercise. 

4 – Choose Representative Products 

Don’t use actual medicinal products in your validation exercise, instead use placebos or simulated loads with similar thermal mass and packaging when performing the exercise. 

5 – Map Out the Route 

Evaluate and document every leg of the transportation process, including loading, transit, unloading, and storage points. Ideally choose final destinations that are the furthest away from your operations. For example, within the UK consider sending parcels to the Scottish Highlands, where deliveries typically take 2-4 working days and Truro, the most southerly city in the UK. 

6 – Stress Test Worst-Case Scenarios 

Consider route delays, long customs holds, or broken refrigeration units as part of your risk assessment and validation exercise.  

7 – Train Your Staff 

Ensure all personnel involved in transport validation understand GDP requirements and know how to correctly package medicinal products and the validation exercise equipment and documentation. 

8 – Re-validate When Necessary 

Re-do validation exercises with your transport provider using a risk-based approach and whenever there are changes seasons (Summer and winter), to products, packaging, routes, vehicles, and/or transport providers. 

9 – Integrate into Quality Management System (QMS) 

Ensure transport validation is part of your overall QMS and quality risk management processes.  

10 – Document Everything 

If using an outsourced transport provider, ensure a written agreement is in place that clearly documents the roles and responsibilities of all parties, ensure the agreement permits on-site audits and includes any sub-contractors they may use. Many couriers outsource the final mile of deliveries to another service provider; this must be factored into your validation exercise. 

Don’t forget to maintain complete records of all validation protocols, test conditions, results, deviations, and corrective actions. If it’s not documented, it didn’t happen! 

Conclusions 

Effective transport validation is more than just a tick-box exercise, it is a critical component of you QMS that ensures the safety, efficacy, and quality of your medicinal products.  

By following GDP guidelines and implementing robust risk assessments and effective transport validation exercises, pharmaceutical distributors can not only comply with regulations but also build a safer, more resilient supply chain. 

Met Office data suggests that UK temperatures are rising year on year, and the number of above 25°C days increase, especially in southern areas, regulator expectations on transportation methods of medicinal products are increasing. As a result, transport validation will continue to play an essential role in pharmaceutical logistics.  

Advice and Support 

Paradigm Shift Consulting offer a range of temperature control and monitoring services including performing supplier audits on your behalf, this includes auditing transport providers, we can also assist you with performing risk assessments and transport validation exercises. 

We also have a cost-effective GDP Awareness, Driver Training and Global Transportation online training courses that can be taken at a time convenient to you and your organisation. We can even tailor training courses and deliver them at your site! 

If you wish to know more, drop us a line using the contact form just below at the bottom of this page.