Case Study 1. CCS

• Country: Germany
   
• Type of Company: Mid-sized biologics manufacturer
   
• Products: Monoclonal antibodies, sterile drug products
   

The client faced increasing regulatory expectations under EU GMP Annex 1 revision but lacked a formal, integrated Contamination Control Strategy (CCS). Key issues included:

• Fragmented sterility assurance practices across departments
   
• Missing site-wide Quality Oversight on aseptic processes
   
• Environmental Monitoring (EM) plan not risk-based nor CCS-driven
   
• Weak aseptic behavior oversight, leading to operational inconsistencies
   
• Approaching health authority inspection with identified gaps
   

GMP Bridge was engaged to design and implement a fully integrated CCS program, including:

• Development of a customized, site-wide Contamination Control Strategy document
   
• Comprehensive Contamination Control Risk Assessment (CCRA) to identify and prioritize risks
   
• Implementation of a Quality Oversight Program to ensure process ownership and governance
   
• Optimization of Environmental Monitoring strategy and sampling plans
   
• Delivery of targeted aseptic behavior trainings across QA and Production
   
• Full alignment with EU GMP Annex 1 (2023) and PDA Technical Report 90
   
• Support in drafting SOPs and updating documentation for long-term sustainability
   

• CCS fully implemented and auditable prior to planned inspection
   
• Stronger sterility assurance framework across all aseptic operations
   
• Risks systematically identified and mitigated via risk-based actions
   
• Regulatory compliance restored and inspection readiness achieved
   
• Enhanced operational ownership through a dedicated Oversight Program
   

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