Client Profile
- Country: Multi-site project across Europe and North America
- Type of Company: Global biopharma manufacturer
- Products: Monoclonal antibodies and sterile drug products
Challenge
The client operated multiple biologics manufacturing sites using diverse Quality processes. This led to inconsistent batch release practices, redundant documentation, and poor visibility of Quality performance across the network. Main challenges included:
- Different batch review, deviation handling, and release processes at each site
- Inefficient, non-standardized procedures slowing operations
- Lack of global KPIs to monitor Quality in Operations
- Minimal collaboration between QA and Production leadership
- Difficulty scaling operations while maintaining control and compliance
Solution Delivered
GMP Bridge led a global harmonization program focused on operational Quality, including:
- Mapping of core Quality processes (deviations, CAPA, batch release, shop-floor QA activities) across all sites
- Identification of inefficiencies and gaps, consolidating best practices into standardized global procedures
- Development of a unified Quality KPI framework covering batch release times, deviation rates, and QA responsiveness
- Facilitation of leadership workshops to align QA and Production teams globally
- Implementation of governance routines and a global Quality Oversight structure to drive consistency and accountability
Impact & Results
- Standardized Quality in Operations processes across all manufacturing sites
- Reduced procedural complexity and eliminated local inefficiencies
- Global KPIs deployed to monitor and improve Quality performance
- Improved collaboration between Quality and Production teams
- Increased operational control and visibility for corporate leadership
- Strong foundation for future digitalization and efficiency initiatives
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