Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Transport Validation Exercises: A GDP Compliant Approach
The Importance of Transport Validation Exercises: A GDP Compliant Approach
In the pharmaceutical industry, patient safety is paramount. One critical element in ensuring that safety is maintained throughout the supply chain is the transport you use to deliver your medicinal products to your customers.
As medicinal products and devices move from manufacturers to distributors, and from distributors to the persons authorised to dispense medicinal products to patients, maintaining product quality and integrity is essential.
In order to comply with Good Distribution Practice (GDP) guidelines and regulatory requirements, pharmaceutical distributors must be able to demonstrate that transportation methods used to deliver their products to their customers consistently maintain the documented storage requirements for the product. This applies not just in the warehouse, but also during transportation. Consider transporting medicines as an extension of your storage facilities.
Making sure of it…
Pharmaceutical wholesalers must be confident that their transport provider is not only GDP compliant, but that they are capable of transporting medicinal products and devices to the required storage conditions.
As per EU GDP Guidelines (2013/C 343/01) Chapter 9.1:
“It is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport.”
The guidelines go on to state:
“…it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity….”
Transport validation exercises are a vital tool in ensuring your transport provider is capable of meeting these requirements.
Why Transport Validation Matters
Protects Product Quality
Medicinal products exposed to temperatures outside of their documented storage conditions, extreme fluctuations in humidity, or damage sustained during transport can impact their quality and integrity rendering them ineffective or unsafe. Validating your transport provider and routes helps to identify any areas of risk and put measures in place to ensure they are mitigated.
Ensures Regulatory Compliance
Regulatory authorities such as the Medicines Healthcare products Regulatory Agency require GDP compliance at all times, which includes the transportation of medicines. Failure to ensure your transport methods are effective in maintaining product quality and integrity, can lead to costly product recalls, put patients at risk of supply chain shortages, and risks the regulator noting non-conformances against your organisation during regulatory inspections.
In serious cases of patient harm or consistent failure to deliver medicinal products in a safe state, your WDA may be suspended or revoked.
Reduces Risk
A validated transport process and risk assessment helps to identify areas of risks such as temperature excursions, delays, or vehicle malfunctions before they impact real shipments, and allows you to make decisions as to whether the transport provider is suitable for your transportation needs.
Supports Product Traceability
EU guidelines require accurate documentation of every GDP activity performed by your organisation. Successful transport validation exercises contribute to full supply chain transparency and traceability.
Builds Customer Trust
A documented and validated transport exercise and risk assessment highlights your commitment to product quality to manufacturers, customers, and regulatory bodies.
Conclusions
Transport validation is more than just a tick-box exercise; it is a critical component of your QMS that ensures the safety, efficacy, and quality of your medicinal products.
By following GDP guidelines and implementing robust risk assessments and transport validation exercises, pharmaceutical distributors can not only comply with regulations but also build a safer, more resilient supply chain.
As the UK climate changes (Met Office data suggests that UK temperatures are rising year on year and as such, regulator expectations on transportation methods of medicinal products are increasing), transport validation will continue to play a pivotal role in pharmaceutical logistics. Investing time and resources into well-planned, well-documented validation exercises now is not just good practice, it is essential for licence retention!
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, and assisting 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!
Please contact us today for a free 5-minute consultation to see how Paradigm Shift can help you ensure compliance within your organisation.
Call us using the number at the top of this page, or the contact form below.
You could also use the more comprehensive executive contact form if you need more in-depth assistance.