The need for better control of the pharmaceutical supply chain was raised throughout discussions about adoption of the European falsified medicines directive. Now, with the directive adopted, the European Commission (EU) has published draft good distribution practice (GDP) guidance.
“Today’s distribution network for medicinal products is increasingly complex and involves many players. The quality and the integrity of medicinal products can be affected by a lack of adequate control over the numerous activities, which occur during distribution”, reads the draft guidance.
Supply chain complexity creates opportunities for biopharmaceutical counterfeiters and adulterers and the draft guidance recognises “it is also necessary to address the threat that falsified medicinal products pose to the distribution channel”.
Current European GDP guidance was published in the 1990s and, considering the changes to the supply chain since then, is considered to be inadequate by the EC. Advancements of practices for appropriate storage and distribution are two elements the EC has considered in the draft.
For example, the draft guidance states: “Storage areas should be temperature mapped under representative conditions and should take into account seasonal variations. An initial mapping should be carried out prior to the commencement of use.”
The EC dedicates a small section of the guidance to what to do with suspected falsified medicinal products and the topic crops up throughout the document. Distributors need to make staff aware of the risks and have procedures in place in the event a suspicious product is found.
“Any suspected falsified medicinal products found in the supply chain should be immediately physically and securely segregated from legitimate medicinal products. All products and relevant activities should be recorded”, reads the draft guidance.
The deadline for comments is December 31. A copy of the current guidance is available here.