@Risk

With news of the impending flu season now making headlines every week, it’s no surprise that lately I’ve been thinking about supplier risk in the medical products supply chain.

The globalization of manufacturing and supply of medical products has created an array of significant supplier risk management challenges for the industry, for governing organizations like the FDA, and for the international health care community as a whole.

Chief among these challenges are questions like these: How can the safety of medical products be ensured? and Who, ultimately, is responsible for securing the global medical products supply chain?

Daniel Matlis, president of Axendia, addresses these issues in his excellent post, “Securing the Global Supply Chain: FDA’s or Industry’s Responsibility?”, published last week at PharmTech.com.

Matlis outlines the roles of both the industry and the FDA.

For the industry perspective, he quotes Gerald Migliaccio, Vice President of Quality, EHS and Agility at Pfizer Global Manufacturing and keynote speaker at a joint session of the PharmTech Conference and the 4th Annual Manufacturing Execution System in Life-Sciences Congress last month.

“Supply chain security is the responsibility of all parties involved in procurement/ sourcing, manufacturing, packaging and distribution of raw materials, intermediates and final product,” Migliaccio says. “Ultimately, the marketing authorization holder (industry) is responsible for assuring that all parties in the supply chain fulfill their responsibilities for delivering safe and effective medicines to customers.”

Migliaccio goes on to list the key elements for managing supplier risk at the industry level:

• managing supply chain security –including financial viability of suppliers, ethical business practices, physical security, container and transport security, and personnel security

• maintaining supply chain quality – Note here: Matlis points out that in a recent Axendia study on QMS trends in Life-Sciences, only 34% of respondents reported that they view global quality data in real time.

• counterfeit prevention

• business intelligence

• crossfunctional collaboration between internal and external stakeholders

The FDA’s role is detailed in its report Safer Medical Products: Investments for Supply Chain Safety and Security. The agency is planning

• a budget increase of $166,433,000 and 346 FTEs to improve medical product supply chain safety and security

• enhanced oversight of entities in the supply chain

• beefed-up FDA inspections and field exams, integrated federal-state oversight, and greater access to inspection data and results acquired from trusted foreign regulatory authorities

Clearly, securing the global supply chain of medical products is critical. What good is the most advanced flu vaccine if we can’t guarantee not just its efficacy, but its purity and safety, as well?

As Migliaccio so aptly sums it up, “While we have been very successful at advancing science and risk-based approaches to quality, all of our efforts can be rendered moot if we cannot secure the supply chain.”