Could you briefly discuss best practices when it comes to responding to supply-chain security breaches?
A centralized effective incident management process for intentional adulteration, theft, illegal diversion and counterfeits
is important. A comprehensive process should have the following attributes: accurate and timely incident reporting; timely
investigation; immediate actions where appropriate (e.g., notifying regulators and law enforcement); risk assessment; identifying
root cause if applicable; executing corrective and preventative actions; monitoring, analysing and reviewing trends; and continuous
improvement. This is not that dissimilar to the processes we use in our quality management systems.
The serialization implementation discussion group aims to get companies to collaborate on implementing differing requirements
globally; could you discuss the challenges involved in this process and the steps being taken by Rx–360?
First, it is important to point out what Rx–360 is not doing with this discussion group. We are not advocating on the various
legislation and/or regulations being developed globally. There are other organizations actively engaged where our member companies
participate so we decided to focus on an unmet need, which was to create a forum where supply-chain stakeholders could share
information and approaches being taken to implement solutions and make investments (e.g., technical and IT) in a world where
significantly different models are being developed. The challenges are obvious when we all work in a global marketplace.
Lynne Byers is vice president of quality at GlaxoSmithKline.
Brian Johnson is senior director of supply- chain security at Pfizer.
1. FDA, "Counterfeit Version of Avastin in US Distribution" (FDA website, 2012)., accessed Nov. 12, 2012.
2. WHO, "Medicines: spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines" (WHO website, 2012), accessed Nov.
3. Rx–360, "Rx–360 Points-to-Consider: Optimizing Pharmaceutical Raw Material Tamper Evidence" (Rx –360 website, 2012),
accessed Nov. 12, 2012.