It is up to pharmaceutical companies sponsoring clinical trials in the EU to have comprehensive control of their supply chain. This ensures the quality of their drug supply is not compromised and patients are not inadvertently administered counterfeit or falsified drugs.
Recently, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) opened an investigation into a patient complaint of mold on paracetamol (acetaminophen) tablets.1 It discovered the product was shipped by sea from India to multiple companies in the U.K. at temperatures reaching up to 60 degrees Celsius. Labeling for paracetamol tablets typically states that they should be kept below 30 degrees Celsius. In addition, MHRA discovered the humidity levels exceeded 80 percent during shipping, which is too high for the packaging that was used. These excursions impacted the drug’s ability to maintain the stability and quality intended by the manufacturer. As a result, MHRA ordered a recall of four shipping containers, which included over 100 batches of drug product. Because the created in 1994 was to encourage the safety and security of the pharmaceutical supply chain and outline the standards expected by EU countries and those trading with the EU. While the guidance was focused on commercial products, it is considered best practice for clinical trial shipments. It also helps prepare companies for what is expected when a product is approved for commercial marketing.
The EU GDP Guidelines detail pharmaceutical supply chain safety and security standards that companies are expected to abide by. While focused on commercial products, these guidelines are considered best practice for clinical trial shipments.
As a result of the Falsified Medicines Directive and the increased threat of falsified medicines entering the legitimate supply chain, significant changes were made to the EU GDP guidelines in 2013. These changes also took into account the globalization of pharmaceuticals and supply chain complexity. The updates included several new sections as well company arranging these shipments had failed to follow the recommended practices outlined in the EU Good Distribution Practice (GDP) guidelines, the mistake not only cost the company time and money but it also put the future of any company receiving the product at risk.