Doubled outputwithout a new production line
How we turned a supposed investment problem into a success story at a pharmaceutical company through Lean methodology and GMP-compliant optimization.
A pharmaceutical company faced what seemed like a clear conclusion:
“We need a new production line. The current labeling machine is our bottleneck.”
The value stream analysis confirmed it at first glance. The machine was slowing down the entire system. Capacities were piling up, deadlines were under pressure, and production planning became increasingly difficult. The logical next step appeared to be an investment in a new, expensive machine, including additional cleanroom space, validation effort, and infrastructure adjustments.
But one thing was clear to me immediately:
Before talking about investing several hundred thousand euros, we needed to understand what was really happening.
The shift in perspective: not buying. Understanding. Improving.
Instead of taking the quick path of purchasing new equipment, we started small, pragmatic, and data-driven, with a setup workshop and the introduction of a lightweight mini-MES system.
We:
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systematically recorded all machine times
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broke the entire process down into preparation, execution, and follow-up
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classified internal and external setup activities
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made search times, documentation efforts, and organizational detours visible
Even at this stage, one insight became clear:
The machine itself was not the problem. The surrounding organization was.
Lean meets GMP and delivers real impact
Especially in pharmaceutical environments, preparation and follow-up times are often longer than the actual value-adding work. Documentation, approvals, and safety checks consume a significant amount of time.
Using a clearly structured, GMP-compliant approach, we identified the key levers:
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reduction of search times through clear material provisioning logic
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GMP-compliant optimization of checklists and workflows
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standardized preparation steps
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optimized follow-up processes
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clear roles and responsibilities within the setup process
All of this was achieved without any technical changes to the machine, without modifying equipment, and fully validation-safe.
The result: double the output with zero investment
The impact was remarkable.
We achieved double the output of the labeling machine.
The organization was suddenly able to produce the required volumes in a stable, predictable manner and without stress. The planned investment in a new machine became unnecessary, as did the need for additional cleanroom space.
Because it shows what becomes possible when organizations do not settle for the obvious solution, but take the time to truly understand how a system works.
Lean and GMP are not contradictions. On the contrary, together they enable precise, safe, and highly effective improvements that can make major capital investments unnecessary.
This success story demonstrates how much potential lies within organizations, when people are willing to look closely and improve consistently.
Are you ready for your own success story?
Let’s talk – I will support you in turning it into reality.
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