DCAT Archives: Programs & Events
Predicting and Identifying Disruptions to the Supply Chain: Geopolitical Environmental Scanning
Janeen Skutnik, Director/Team Leader of Quality & Regulatory Policy, Pfizer Inc.
Presented on Thursday, November 5, 2009 at the Hyatt Regency Hotel,
New Brunswick, NJ.
Geopolitical environmental scanning is keeping tabs on the global economic and political situations, as well as what is happening in other industries, and then using that information to look for potential vulnerabilities.
Why is this important? Geopolitical environmental scanning and monitoring is critical to identify red flags that could affect the supply chain, the industry’s products and ultimately the patients we serve. Recent case studies, such as the Heparin, acetonitrile, and melamine events highlight the importance of understanding the dependence of a product on its sourcing components. “A proactive awareness of global issues and extrapolation to your company’s business can help you be better prepared,” said Skutnik.
Heparin is sourced from pigs (50 million pigs are required to source one year of Heparin production). China, where the majority of the pig population comes from, was experiencing a severe decline in pig population due to disease and a corresponding increase in price. These pressures led to adulteration.
The major use for acetonitrile is in the pharmaceutical industry in such areas as extraction, isolation of antibiotics, insulin and vitamins, and as a processing solvent and analytical laboratory chemical. However, the acetonitrile supply/demand balance is totally governed by acrylonitrile output from the automobile industry, which is experiencing an overall slowdown and plant problems. Skutnik discussed technical solutions and market options for dealing with this situation.
While the pharma industry was not directly affected by the melamine incident, it did highlight vulnerabilities in the supply chain. Through the use of geopolitical environmental scanning, Skutnik explained that one company was aware of the potential risks prior to FDA guidance.
In light of these case studies, Skutnik posed the following questions.
> How is the global recession affecting our industry
> What preparations is your company making to deal with potential closures of excipient
and chemical plants and the lack of availability of materials?
> Does this present an opportunity for substandard/counterfeit suppliers?
Skutnik recommended that attendees:
> Keep tabs on global news and headlines. This is easier to do than ever before.
> Incorporate critical thinking and strategic thinking throughout your organizations.
> Determine if certain items can impact your company or the pharmaceutical industry.
This does not need to take a lot of time or resources.
In summary, Skutnik suggested that all sectors of the industry (quality, regulatory, procurement and legal) need to be reviewing news and events for its impact on production and plan strategies with the goal of securing the supply chain and saving lives. Different people see different issues, which will help companies better prepare and make this a competitive advantage for them.