Supplier Controls Move to Stricter Management

In the past five years, several contaminated pharmaceutical products have led to patient injuries and deaths globally. The emphasis on the linkage between supplier control and risk management will continue to increase.

US and European regulatory bodies have been forced to increase their supervision on supplier controls for the pharmaceutical and medical device industries as risk of incidents in pharmaceutical line increases.

In December 2008, the Global Harmonization Task Force issued a guidance document that outlines the steps medical device manufacturers should include in their supplier control process.2 A second document issued in November 2009 (in draft form) describes the techniques for inspecting a medical device manufacturer’s supplier controls.3 At an AdvaMed Conference in 2009, Kim Trautman from the US FDA said: ‘Supplier control is a much bigger issue now than it was in 2007. Even though issues with toothpaste and nuts are not directly in the device sector, these events still greatly affect FDA thinking and controls. The emphasis on the linkage be