Case studyPharma

Stabilizing and Transferring a Tablet Production Line

Pharmaceutical company with cross-site tablet production

Critical problems in the tablet production line led to budget escalation, production bottlenecks and frequent batch failures.

The challenge

The situation

Critical problems in the tablet production line led to a budget escalation and considerable production bottlenecks. The existing processes were inefficient and caused frequent batch failures and delays to the product launch.

Our approach

What we delivered

Optimized shift planning for the production line, to resolve the bottlenecks that were delaying the launch.

Upgrade of the tablet press in response to the frequent batch failures originating from the equipment itself.

Strategic hire to coordinate the line, so that the optimization has someone accountable for it beyond the project period.

The outcome

Results & impact

Four months to launch

Product launch achieved within four months.

5% batch failure rate

Reduced rate of batch failures in the production line.

EUR 25 million budget frame

Implementation within the defined budget frame.

In summary

The tablet production line is stabilized; the product launch was achieved within four months and within the set budget frame.

Related expertise

Production Transfer & Scale-Up →

Transfer strategy and gap analysis between donor and receiving site, scale-up under ICH Q8

Lean Manufacturing →

Systematic OEE measurement and changeover time reduction via SMED in a validated environment

CAPEX Planning & Qualification →

A User Requirement Specification with GMP requirements, FAT, SAT and qualification

Lean Six Sigma →

Value stream mapping and Six Sigma belt programs in regulated production

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Sources

Entourage project experience (anonymized)

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