PharmTech:
Could you briefly discuss best practices when it comes to responding to supply-chain security breaches?
Johnson:
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.
PharmTech:
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?
Johnson:
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.
References
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.
12, 2012.
3. Rx–360, "Rx–360 Points-to-Consider: Optimizing Pharmaceutical Raw Material Tamper Evidence" (Rx –360 website, 2012),
accessed Nov. 12, 2012.
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