Case Study Overview
Contamination Control Strategy (CCS) is now a cornerstone of EU GMP Annex 1 compliance. For biologics manufacturers, gaps in sterility assurance or Environmental Monitoring can lead to failed inspections, product risks, and reputational damage. This case study shows how GMP Bridge helped a mid-sized manufacturer in the DACH region design and implement a compliant CCS, strengthen oversight, and achieve inspection readiness ahead of schedule.
The Challenge
A mid-sized biologics manufacturer in the DACH region needed to rapidly align with the revised EU GMP Annex 1 requirements. Sterility assurance processes were fragmented, Environmental Monitoring lacked risk-based design, and an upcoming health authority inspection was approaching with identified compliance gaps. Without a structured Contamination Control Strategy, the site risked critical findings and delays to market supply.
