Supplier Change Notification
Handling Material Change Notifications & Re-qualification in Pharma
Handling Material Change Notifications & Re-qualification in Pharma How to Manage Material Change Notifications and Supplier Re-qualification in Pharma In the highly regulated pharmaceutical industry, even minor changes to raw materials, excipients, or packaging components can significantly impact product quality and patient safety. Consequently, material change notifications and supplier re-qualification are critical components of GMP-compliant change control systems. Failure to properly evaluate, document, and respond to such changes can result in data integrity issues, non-compliance during regulatory inspections, or even drug recalls. This article provides a step-by-step approach to handling supplier change notifications, risk assessment, requalification, and regulatory expectations, tailored…