In simple words, lean strives to reduce the waste from any process or function that does not create value but uses resources.

The lean experience within pharmaceuticals has not been a clean one.  Compliance problems, globalization, as well as production and pricing demands, have been a huge impediment over the profitability and competitiveness of pharmaceutical companies in general.

The amount of waste created by this industry amounts to billions of dollars per year, and pharmaceutical companies are opening their eyes to the value of finding more efficient ways to operate, making lean manufacturing the preferred method for many.

The success of these practices, however, has been scarce, since traditional lean manufacturing practices do not fit the very dynamic and difficult pharmaceutical production demands.  If an ingredient is not available, for example, even in the event of a crisis, lean manufacturing will not be able to work.

In view of this, some companies have tried technology to achieve leaner production based on demand, but even so, they are still looking for ways to improve manufacturing.

To be able to benefit from lean, pharmaceutical companies, must have global vision of production performance, optimization, and simulation capabilities which enable them to create scenarios of better performance, even under the variability equation.  This equation is nowhere as strong as it is in pharmaceuticals, where the need for different strength, packaging, and presentation styles is enormous.  Stocks can easily expire because of new products that can make the past ones obsolete.

The reality is that lean is effective in meeting predictable demand at the lowest cost possible.  In an industry where you can always count on change, it is easy to see how traditional lean is struggling to fit in.

But there is hope.  Next generation software and methodologies have proven capable of adapting to the traditional lean manufacturing ways.  This software considers variability and works to minimize its impact by adjusting traditional performance metrics, using flow path management to create more flexible ways to define value streams and organizational structures.

To start reducing the amount of waste, companies must combine lean and flow-based manufacturing methodologies, simulation and analysis software.  In the future, pharma will be able to break down organizational structures and integrate manufacturing processes.  Decisions will be made according to flow through the factory, improving the control over the main performance indicators.  Decision making impacting the plant floor will improve because of real-time data availability, reducing inventory and cycle times drastically.  Companies will be able to define best practices and prioritize metrics based on business goals and challenges.

So, even if lean works best where stability and predictability are the norm, new ERP tools may help to successfully apply lean to pharmaceuticals.  Expert pharmaceutical consulting firms possess all the expertise to guide companies through the lean process, pinpointing its strengths and weaknesses clearly for every specific case.

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