Client Profile
- Country: Germany
- Type of Company: Mid-sized sterile injectables manufacturer
- Products: Liquid drug products in vials and pre-filled syringes
Challenge
The client faced chronic delays in batch release, with average timelines reaching 25 days. This created warehouse bottlenecks, strained client relationships, and increased financial penalties. Key issues included:
- Excessive deviation volume, many repeated
- Weak root cause analysis and ineffective CAPAs
- Overcomplicated Master Batch Records (MBRs)
- Paper-heavy documentation flows causing handover delays
- Qualified Persons (QPs) acting as late-stage reviewers rather than proactive quality partners
Solution Delivered
GMP Bridge led a 9-month batch release optimization program, focusing on root causes rather than symptoms:
- Mapped the complete batch release process across QA, QC, Production, and QPs
- Simplified and redesigned MBRs to align with real shop-floor practices
- Improved deviation investigations and CAPA effectiveness through coaching and process changes
- Replaced manual documentation loops with hybrid digital tools where feasible
- Involved QPs earlier in the process to enable upstream quality decisions
- Facilitated cross-functional workshops to improve collaboration and ownership
Impact & Results
- Average batch release time reduced from 25 to 15 days (40% improvement)
- Fewer repeated deviations and improved CAPA follow-up
- Smoother documentation flow and reduced paperwork bottlenecks
- Enhanced collaboration between QA, QC, Production, and QP functions
- Increased client satisfaction and reduced regulatory risk
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