Reduction in release time for high-value APIs
Boosting QC Lab Productivity and Service Levels Through EFESO’s Proprietary Approach
A multinational chemical-pharmaceutical company faced recurring challenges in its Quality Control (QC) labs, where complex API analyses, long release cycles, and increasing workload pressures regularly triggered requests for additional headcount. By applying EFESO’s proprietary QC lab optimization framework, the organization achieved simultaneous gains in productivity without compromising quality.
Our Client
A multinational chemical-pharmaceutical company producing both proprietary and generic drugs. Its Quality Control labs manage complex analytical requirements for high-value Active Pharmaceutical Ingredients (APIs), including highly sensitive injectable products requiring up to 130 hours of analysis and several weeks of release procedures.
The Challenge
Quality Control labs were under pressure to manage fluctuating workloads, long release cycles, and rising demands for additional personnel, all while ensuring high service levels for high-value APIs.
- Workload and scheduling inefficiencies: Labs struggled to level workloads and manage the complexity of release analyses requiring 130 hours and multiple specialists.
- Pressure on service levels: Delayed releases of high-value batches—worth up to €1M each—created significant financial exposure.
- Reactive requests for extra personnel: The absence of optimized processes and workload leveling repeatedly led to demands for increased headcount.
- Unstable performance: Variability in analytical performance and release times threatened competitiveness and cash conversion.
Real Results Achieved Together
The EFESO approach delivered measurable improvements across all labs, including substantial productivity gains and increased process reliability.
Productivity increase (release time per batch)
Reduction in required FTEs through optimized flow and better workload leveling
Transformation Impact
- Improved release speed for million-euro API batches.
- Reduced waiting, downtime, and analytical variability.
- Better workload leveling, reducing the need for routine staffing increases.
- Increased operational stability thanks to synchronized workflows and visual management tools.
- Successful cultural shift, overcoming initial resistance from lab coordination teams.
Our Approach
EFESO deployed a two-phase methodology combining deep assessment and hands-on implementation in the most critical API lab.
Comprehensive QC Lab Assessment
- Applied EFESO’s standard framework for lab sizing and QC process optimization.
- Assessed analytical and non-analytical workload volumes.
- Evaluated capacity scheduling, prioritization, organization of activities, and performance tracking.
- Identified improvement opportunities including workload leveling strategies and optimal lab sizing (based on average capacity rather than peak demand).
Full Implementation in High-Value API Lab
- Optimized standard work for analyses requiring 130 hours and multiple specialists.
- Introduced enhanced visual scheduling and real-time performance monitoring.
- Synchronized workflows to reduce waiting time and downtime.
- Installed prioritization tools to improve release flow and analytical tracking.
- Ensured results were understood and accepted, overcoming initial skepticism from leaders closely attached to legacy processes.
Facing Similar QC or API Laboratory Performance Challenges?
- Long release times for high-value products
- Facing recurring requests for additional QC personnel without addressing root causes
- Managing complex API or pharmaceutical analyses with fluctuating workloads
- Looking to stabilize lab performance and improve service levels?