Client Profile
- Country: Austria
- Type of Company: Mid-sized sterile fill & finish manufacturer
- Products: Sterile liquid drug products
Challenge
The client relied on a growing network of raw material and service providers but lacked a structured approach to supplier qualification and oversight. This led to:
- Inconsistent supplier evaluations and qualification processes
- Limited visibility of supplier risks and compliance gaps
- Delayed approvals and disruptions in production due to missing documentation
- Weak audit coverage of key material suppliers and service providers
- Increasing pressure from clients and authorities to improve supplier management
Solution Delivered
GMP Bridge supported the client with the design and rollout of a risk-based Supplier Qualification and Audit Program:
- Mapping of all GMP-relevant suppliers and service providers, including CMOs and testing labs
- Prioritization using risk-based criteria to focus resources on critical suppliers
- Development of a standardized supplier qualification process, including approval workflows and documentation requirements
- Design of an annual audit plan focusing on high-risk and strategic suppliers
- Execution of remote and on-site supplier audits by internal and GMP Bridge lead auditors
- Development of a supplier monitoring dashboard with clear KPIs and follow-up actions
- Training of internal teams in supplier management and audit readiness
Impact & Results
- Improved control and visibility over the supplier network
- Risk-based qualification and monitoring approach implemented
- Increased audit coverage for critical suppliers and outsourced processes
- Reduced supplier-related production delays and compliance risks
- Strengthened position in client audits and regulatory inspections
- Internal QA team trained to sustain and manage the program autonomously
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