PharmTech: What best practices can you offer for the industry to monitor their materials coming through global supply chains, especially with products coming from emerging markets, such as China and India?

Byers: Rx–360 develops and shares best practices and points to consider in relation to the security of the supply chain. This ­information is freely available on the Rx–360 website. One example of a point to consider relates to tamper evident seals, which are used on raw material containers (3).

Johnson: Companies need to have comprehensive supplier quality management programs to monitor and manage materials and products from external sources, regardless of the region being sourced from. This starts with supply chain transparency and a good understanding of all of the "players" in the supply chain. When the supply chain is well understood, companies can then use risk-assessment processes to determine appropriate strategies to mitigate risk, including risks associated with sourcing from regions with less developed regulatory infrastructure. Having clear requirements, good contracts, and robust oversight programs to ensure your suppliers meet your expectations are foundational.

Johnson: As an industry, our biggest challenge and our greatest opportunity is tackling supply-chain security threats holistically. We have historically organized around individual threats, such as counterfeiting or specific parts of the supply chain, such as contract manufacturing. We also have not always balanced prevention, detection, and response to these threats. Winning this battle will require collaboration across the supply chain and between all stakeholders.

What we are trying to do in Rx–360 is to promote a holistic approach to supply-chain security. This includes defining the supply chain broadly (end to end), recognizing the advantages of working on the threats (counterfeiting, theft, diversion, and intentional adulteration) collectively, and balancing prevention, detection, and response. Our first whitepaper on comprehensive supply-chain security programs captures many of these concepts and is a good roadmap for the supply-chain security work we will be doing.

PharmTech: Could you give some background on the aims and functions of the different supply-chain working groups under Rx–360 and what each working group has achieved to date?

Johnson: Rx–360 endorsed the creation of the supply-chain security working group in October 2011. The goal of this working group was to promote a holistic approach to supply-chain security. We kicked off four working teams towards the end of 2011. The objectives for each of the teams were:

SCS Management Systems—Benchmarking and white paper describing comprehensive supply-chain security program.

Conveyance Risk Management—Benchmarking, development of risk model and white paper on using risk- based approaches to conveyance security.

Market Monitoring—Benchmarking, white paper and framework on good practices/tools-techniques, emerging technologies, to monitor the market for criminal activity.

Audits and Assessments of Third Party LSP's—Points to Consider for audits/assessments; audit standard methodology; audit tools for LSP's.

Free webinars were conducted for each workgroup and the whitepapers are currently posted on the Rx–360 website. This was all accomplished in approximately six months.

We also recently kicked off four additional workgroups with the following objectives:

Incident Management—benchmarking and development of a white paper describing a process to respond to supply-chain breaches.

Illegal Diversion—benchmarking and development of a white paper on approaches to prevent, detect, and respond to illegal diversion.

Drug Shortages—benchmarking and development of best practices for what companies can do to prevent supply-chain security breaches resulting from drug shortages.

"Serialization" Discussion Group—discussion group to share information on strategies and challenges for implementing serialization globally.