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Do EU GDP Guidelines Really Ensure IMP Integrity During the ‘Last Mile’?


By: Alex Guillen January 23 2017

Tags: Key Topics, Blog, Regulatory Issues, Compliance, Shipping

GDP Guidelines

Firstly, I think it is important that we define ‘last mile’. Last mile for clinical trial supplies is very different to last mile for commercial pharmaceutical products.  For many years cold chain management by pharmaceutical companies ended at the Distribution Center. Commercial products were then transported to the pharmacy for safe storage until collected by the patient. The last mile for commercial products was between the Distribution Center and the Pharmacy. Due to revised EU GDP Guidelines, it is now the responsibility of the Sponsor to work with local partners, distributors or third party depots to secure adequate cold chain protection all the way to the Pharmacy. These revised EU GDP Guidelines, whilst enhancing protection from the Distribution Centre to the Pharmacy, have had an impact on the Sponsor - more responsibility and a substantial increase in cost as commercial products need to be monitored across this ‘last mile’.

In the case of clinical trials, the industry norm is for clinical supplies to be shipped to the investigator site and the patient then visits the investigator site to receive the medication. Therefore, the ‘last mile’ for clinical trials is from the Distribution Center to the investigator site.

While commercial drugs have stability data that allows us to understanding the impact on the drug if the cold chain is broken, clinical supplies have limited or no information on stability data. It is for this reason that they require even more strict control upon delivery. When we add to this the fact that clinical supplies are not only of high cost, but in many cases difficult or impossible to replace, clinical sites have obvious obligations to maintain the integrity of the product. The International Council of Health (ICH) developed the Guidance for Good Clinical Practices guidelines (GDP – EC/R2) to secure proper handling and record keeping on clinical sites. These have been adopted by the European Medicines Agency (EMA) and the World Health Organization (WHO) and these guidelines are often referenced by other countries. Nevertheless these guidelines are very general. Guidelines refer investigator sites to follow the drug manufacturers’ storage recommendations. Consider the impact this can have on investigator sites especially when they have to follow storage recommendations from many different drug manufacturers, often times using different types of temperature monitors.

A switch on current practices could come from Sponsors willing to assume more responsibility and visibility of the clinical supplies up until the drug is administered to the patient. Some Sponsors are in discussion with their distribution vendors as they evaluate possible solutions that would be feasible and affordable. A challenge is the sheer volume of clinical sites per trial and the cost and effort it would take to extend visibility and monitoring control all the way to patient administration.

Today, Fisher Clinical Services assists its customers to have enhanced cold chain visibility at the clinical sites via its Clinical Supply Optimization service. Our work with multinational pharmaceutical and biotech companies, and feedback from an industry recognized Investigator Site Panel, founded by Fisher Clinical Services, has highlighted the need for extended visibility, monitoring and control at the investigator site level. We are working on the best possible technologies to make such visibility in real time. It is important that we strengthen every link of the supply chain so as to prevent excursions and maintain full integrity of clinical supplies even during the ‘last mile’. This is a daily challenge that we, at Fisher Clinical Services, accept every day.

Read the Article: End-to-end Process Excellence to Ensure Uninterrupted Delivery