FDA Scrutiny Prompts Closer Look at Supplier Quality Agreements
This article was originally published in The Gold Sheet
Executive Summary
How good are your supplier quality agreements? FDA investigators are taking a keen interest in them during inspections. These agreements are seen as increasingly important with the rise of global outsourcing, multi-use manufacturing facilities and 'virtual' drug makers. Official with FDA's biologics center outlines key components of quality agreements. Pfizer official gives tips for preparing to negotiate them. Consultant offers detailed template for quality agreements and addresses some key challenges. Post-agreement quality review meetings encouraged. Standard approach to agreements with excipient suppliers urged.