Case Study Overview
Supplier qualification and audit program in sterile manufacturing are essential to ensure compliance, protect supply continuity, and meet rising regulatory expectations. Without a structured framework, supplier-related issues can cause production delays, increase deviations, and trigger negative audit outcomes. This case study highlights how GMP Bridge helped a mid-sized sterile fill & finish manufacturer in Spain establish a robust supplier qualification and audit program — delivering improved oversight, reduced risks, and long-term sustainability.
The Challenge
A mid-sized sterile fill & finish manufacturer in Spain relied on an expanding supplier network but lacked a structured program for supplier qualification and oversight. This created inconsistent evaluations, delayed approvals, production disruptions, and increasing pressure from clients and regulators to improve supplier management.
