Client Profile
- Country: Germany
- Type of Company: Single-site sterile drug substance manufacturer
- Products: Polymers and sterile intermediates for clinical trial supply
Challenge
Following repeated client complaints and observations from health authority audits, the site’s aseptic operations were deemed non-compliant, with high contamination risks and credibility loss. Specific issues included:
- Fragmented and incomplete Contamination Control Strategy (CCS)
- Weak Quality Oversight over aseptic manufacturing processes
- Poorly designed Environmental Monitoring (EM) sampling plans and trending practices
- Repeated deviations linked to gowning, behavior, and material transfer
- Sterility assurance risks not properly identified or mitigated
Solution Delivered
GMP Bridge led a site-wide remediation program focused on sterility assurance and operational governance:
- Execution of a detailed gap assessment of the site’s CCS, EM, and sterility assurance controls
- Development of a new, integrated CCS and supporting Contamination Control Risk Assessment (CCRA)
- Redesign of Environmental Monitoring strategy, sampling plans, and alert/action levels
- Implementation of a formal Quality Oversight Program covering all aseptic operations
- Revision of gowning qualification, material transfer processes, and aseptic behavior routines
- Drafting of new SOPs and practical guidance documents to support behavioral change
- Training and coaching of Production and Quality staff to ensure long-term adoption
- Collaboration with site leadership to secure resources and governance support
Impact & Results
- Restored client confidence and avoided supply interruptions
- Regulatory audit successfully passed following remediation program
- Sterility assurance risks identified and mitigated with risk-based controls
- Operational ownership improved through structured Quality Oversight
- Reduced deviation rates and improved aseptic behavior on shop-floor
- Sustainable framework implemented for long-term compliance and operational excellence
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