Supply Chain Risk Management Standard to Address Pharma Compliance Concerns

A planned, first-of-its-kind U.S. standard on supply chain risk management will include input from a handful of drugmakers to highlight the impact that compliance lapses have on supply chain security, says the chair of a newly formed industrywide panel developing the standard.

The standard will be based on ISO 31000 family of risk-management standards and will improve upon a recent compilation of best practices for managing supply chain risks, said Marc Siegel, commissioner for the ASIS International Global Standards Initiative and the panel’s chair. That compilation highlights natural disasters and man-made disruptions such as last year’s nuclear meltdown in Okuma, Japan.

The new standard “has to talk about the different kinds of risks that supply chains around the world face, and compliance risks are a major one,” Siegel said.

ASIS International, formerly known as the American Society of Industrial Security, convened the panel to develop the new standard. Its first meeting was July 17. The panel reflects a wide spectrum of industries, with representatives from Amazon, Infosys and Coca-Cola seated at the table with officials from Abbott, Johnson & Johnson, Purdue and Roche.

While the inaugural meeting of the panel raised no specific issues and was simply intended to explain the process for developing the standard going forward, supply chain issues are a hot topic, and the sheer volume of information out there can be overwhelming. FDAnews’ Fourth Annual Supplier Quality Management Congress is here to help you.

Next week, July 31-Aug. 2, get three days and two nights of face-to-face interchange with top regulators and policymakers, industry experts, lawyers and consultants discussing actions that are being taken to strengthen the international supply chain.

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