A Changing Regulatory Climate
“Global events have increased customer requirements,” reports Tom Bell, vp for quality control. Tracing the arc of events back to 1990, Bell says that the baseline for market entry was a high level of quality control. By 2000, concerns over prion contamination of animal products ratcheted up the level of production oversight, while in 2004, lean manufacturing practices motivated customers to demand adherence to tight delivery schedules.
New challenges and concerns regarding contamination of heparin with melamine are now taking the front seat, as companies and regulatory agencies struggle with products from Asia that have been compromised through negligence or criminal activity.
“Unfortunately, our regulatory infrastructure was not designed to detect criminal malfeasance,” Bell says. To prevent intentional product contamination, Bell believes that upstream supply chain transparency is required.
“We have to be aware of the level of worldwide malicious activity in the global supply chain. And, we have to constantly keep our guard up and make sure that we are doing everything possible to detect illegal contamination of the supply chain.”
In order to create and monitor a global quality system, SAFC and other members of the industry have formed the Rx-360 Mission, a cooperative program to meet the expectations of the industry and regulators by enhancing product quality and authenticity throughout the supply chain.
The consortium is a holistic approach, consisting of four distinct functions: shared supplier audits, adoption of standards and best practices, a political macroeconomic monitoring and clearing-house for suspicious events, and a cooperative technology-development arm. “Through sharing of issues and practices, we can overcome these complex malicious criminal activities that could take our industry down,” Bell concludes.