Client Profile
- Country: USA
- Type of Company: Clinical-stage biotech scaling towards first commercial product
- Products: Recombinant proteins and sterile injectables
Challenge
The client was preparing for late-phase trials and future commercialization but lacked a fit-for-purpose Quality Management System (QMS). Specific challenges included:
- Existing clinical-phase processes not suitable for commercial GMP standards
- Fragmented procedures developed reactively over time
- Missing governance on change control, deviations, and batch record review
- No structured supplier qualification or Quality Agreements in place
- Risk of failed inspections or client audits if scaling continued without QMS redesign
Solution Delivered
GMP Bridge supported the client by designing and implementing a scalable, compliant QMS tailored to their growth plans:
- Development of a complete QMS framework aligned with EU GMP and FDA expectations
- Prioritization of critical procedures for Phase III and commercial readiness
- Creation of practical SOPs covering deviations, CAPA, change control, supplier qualification, and batch record review
- Establishment of a risk-based Document Management System (DMS)
- Deployment of governance processes for Quality Oversight, leadership reporting, and issue escalation
- Hands-on coaching of QA leadership to enable ownership and long-term management of the QMS
Impact & Results
- Full QMS structure implemented ahead of planned commercial manufacturing activities
- Increased operational control and reduced compliance risks
- Clear governance model for Quality Oversight and regulatory inspection preparation
- Practical, scalable procedures replacing outdated clinical-phase processes
- Stronger internal ownership and alignment of Quality and Operations teams
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