This article is part of PharmTech's supplement on Ingredients, Excipients, and Manufacturing 2011.
PharmTech: On an overall industry basis, what would you identify as the most significant issues facing pharmaceutical companies in terms
of supply-chain security?
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Johnson: Globalization and the resulting complexity in our supply chains are resulting in increased threats for product theft, diversion,
economic adulteration, and counterfeiting. Where companies buy raw materials, manufacture products, and sell products is rapidly
changing. On a global basis we are seeing increased criminal activity in all of these threat categories. This is necessitating
changes in how we operate. Relying on traditional GMP [good manufacturing practices] and GDP [good distribution practices]
alone are not enough. We are in a war against the criminals who are risking patient safety for financial gain.
Brian Johnson, senior director of supply chain security at Pfizer
PharmTech: Issues such as product theft, product diversion, economic adulteration, and counterfeit goods are areas of concern for pharmaceutical
companies. On an industry wide basis, what would you identify as the significant initiatives or programs in place or under
consideration to address supply-chain security, first looking at the United States?
Johnson: There is a lot of work being done by pharmaceutical companies, suppliers, government, law enforcement, and distributors
to address supply-chain security threats in the US market. It is going to take cooperation by all components of the supply
chain to be successful. The weakest link in the supply chain will be exploited by the criminals.
FDA recently published a strategic plan, "Pathway to Global Product Safety and Quality" (1). It outlines four FDA focus areas
that include: increased global regulatory cooperation, improved information sharing, improved intelligence and information-technology
capability, and allocating agency resource using risk-management principles. Foundational to these efforts is engagement and
cooperation with all supply-chain stakeholders. FDA recognizes that we are in this together.
There also are a number of trade organizations, consortiums, and coalitions working on various aspects of this global problem.
Many of these are cooperative efforts between industry, government, and law enforcement. Some examples are: the Pharmaceutical
Security Institute (PSI) and the Partnership for Safe Medicines (PSM) , which are working on counterfeiting; the Pharmaceutical
Cargo Safety Coalition (PCSC), which is working on cargo theft; and the recently formed Supply Chain Safety Consortium, which
is working on track and trace. Rx–360, an international pharmaceutical supply-chain consortium, is a great example of a consortium
where these efforts are coming together to look at supply-chain security holistically. All of these organizations are doing