As mentioned on the Fisher Clinical blog, in today’s increasingly complex world of drug development, global full service providers may be required to work with numerous qualified wholesalers to service their comparator sourcing needs for the clinical trial industry. And this number is projected to increase over the next few years! This increase means the secured global qualification process will become even more important to prevent counterfeiting from entering the clinical trial supply chain. What are the best preventive actions practices for selecting, inspecting and approving wholesalers? They are a necessary support option, particularly when the conditions do not allow for directly sourcing from an originator.
For almost everyone, direct sourcing is the preferred route of supply as it offers the shortest and most safe supply route. Nevertheless, sometimes it’s just not feasible or not desired by the clinical trial sponsor to source directly from the innovator and the reasons can be different. Here are three examples:
- Local sourcing is desired and the manufacturer is not present by its own in particular countries
- The manufacturer has no stock to offer within the required study timelines
- Small quantities
In those cases, it’s very helpful for the clinical study team to have the option of alternative methods of obtaining comparator drugs and a set of fully qualified suppliers provides them flexibility and assurance.
The complete qualification process starts with a risk assessment of the supplier itself. In addition, the country of sourcing should be taken into consideration. Some countries are “safer” than others, depending on the level of regulatory requirement of Medicines Regulatory Authority/Drugs Regulatory Agency for each country, (e.g. GMP; GDP and GCP requirements; legal provisions on marketing authorization; regulatory inspection of manufacturer and distributors; import control; licensing; sanctions concerning violation of codes of conducts; etc.) and the frequency of occurrence of counterfeit drugs in these countries according to WHO and International Medical Products Anti-Counterfeiting Taskforce (IMPACT). Additional documents may be required case by case.
After the audit has been performed and according to audit results suppliers will then be “Approved”. Once you have a pool of different approved providers, it is then possible to select the higher performing provider measured by their track record of product quality, service reliability, delivery time and financial viability.
Quality is not a static condition; quality has to be maintained continuously. Although previously approved suppliers must therefore be re-evaluated in regular intervals, it’s also important to maintain a supplier scorecard to understand and monitor supplier quality and performance over time.
Quality is a key element to consider in comparator drug sourcing. Make sure that you or your supplier is applying the precautions above. We employ this due diligence, and as a result of our quality work, have never had a counterfeit in our supply chain. We all have no money to waste. But at the end of the day it is all our responsibility to ensure that the patients are treated with the right medication in the right quality and that no counterfeit enters the clinical supply chain instead of the comparator drug.