@Risk

In yesterday’s post about the FDA’s new PREDICT program, I included a few startling statistics about pharmaceuticals imports.

Today, new survey results suggest that global life science companies are increasingly concerned about growing global supply chain complexity and its effect on quality and compliance.

The survey, conducted by Sparta Systems, was administered to professionals in the pharmaceutical, biotech, medical device and blood/tissue industries. The data reveals that:

• Three-quarters of those polled work with more than four global suppliers. Clearly, an expanding supplier network like this poses potentially significant threats to supply quality and safety if not managed properly.

• More than half of the respondents feel that varying supply quality standards and differing mandates across countries or regions are the greatest obstacles to managing quality and compliance.

• More than a third of those surveyed believe that their quality management systems are not adequate to manage supply chain risks and promote safety.

• Almost half of respondents reported that their companies are not equipped to manage IT consolidation resulting from mergers and acquisitions. More than one quarter expect these activities would have a negative effect on product quality and safety.

• Nearly one third of respondents do not categorize supplier relationships based on the risks they pose to the organization. To me, this finding is particularly alarming. By omitting this fundamental risk management strategy, these companies are extremely vulnerable to potential product quality and safety issues.

Sparta Systems found similar results when it surveyed medical device organizations last year, and without question, it is becoming increasingly clear that pharma companies, regulatory agencies, and the health care community, in general, have significant challenges to overcome as supplier networks become more and more complicated.

However, securing the global supply chain of medical and pharmaceutical products is critical, and these Sparta Systems’ surveys should be be a wake-up call to the industry. Pharma manufacturers and distributors need to update and improve their systems, so that they can identify and prioritize supplier relationships using a risk-based approach that focuses on quality, compliance, and security.