Rx-360 Technical Paper on Tamper-Evidence and First Opening Indication

The practice of tampering and re-use of original packaging represents a significant threat in the overall landscape of counterfeit and illicit drugs. A problem, which is growing and threatens the global pharmaceutical supply chain as well as patient safety. The increasing threat of tampering and re-use calls for new and different approaches to security for pharmaceutical packaging components.

A specific challenge in the case of packaging re-use is that existing authentication (security) and / or product identity (serial number) features on genuine packaging components may be “re-used” as well and thus provide the user a false impression that the products are genuine and safe. Thus, new mechanisms that allow for clear, irreversible and tamper-evident indication of initial opening / first use need to be better understood.

This technical paper gives a summary of key terms and official definitions from various regulatory and standards organizations used in connection with tamper-evident solutions to enable common understanding and a clear communication. It also gives an overview over the current regulatory and normative standards in the diverse geographies.

To familiarize the reader with technical measures that might be helpful to consider in addressing the threat, an overview of packaging components is presented. This should allow for a better understanding of which packaging components are most suitable for clear indication of first-opening or tampering and which components are limited in regard to this functionality.