Real Lean: A Specific Approach to Generics

Ever since its first introduction by the Japanese automotive industry in the 1980s, lean manufacturing has been successfully adopted by many companies. For more than 10 years BSM have been global leaders in the provision of “Real Lean”. Now, BSM are implementing “Real Lean” in the generics Life Science industry. This effort is not without its difficulties, providing many unique challenges and customization of the lean process.

Within the Life Science industry there has been a rapid expansion in generic manufacturing. With blockbuster brands coming off patent, generic products are now big business, but this expansion comes with growing pains. Generic drugs are subject to the same FDA testing as brand-name drugs. It is common for brand-name drug production sites to focus on producing 5-15 different products. Contrast this with generic manufacturing sites, where they frequently manufacture hundreds of different products, each with their own unique testing requirements. This presents the testing laboratory with a unique set of challenges as the mix and volume of products produced is constantly changing. And it can be months or even years between a production run of a particular product.

We have commonly observed that to cope with the high mix of products and enhanced volatility; many generic testing laboratories create small dedicated groups of analysts (a.k.a. product-experts) that only test specific products. However, this strategy has a major drawback as it creates an imbalance, as some chemists test the more demanding products, while others test the easier products. This misapplication of lean leads to inefficient use of resources, ultimately creating peaks and troughs in analyst workloads.  Another prominent feature of generics labs is a high rate of errors.  This is mainly driven by a lack of order or process, to deal with the ever changing mix of products and sample volume.

At BSM, we continue to build customized approaches to deal with this volatile testing process by introducing mixed work stream levelling, queue-based levelling and product-specific test trains. These processes increase productivity through workload levelling and creating an even distribution of analyst workloads.

As global leaders in implementing “real lean” processes in the Life Science industry, BSM are cognizant of the fluidity of the pharmaceutical market, particularly with regard to generic drugs.  Our approach is to continue to provide customized “real lean” solutions and evolve alongside this ever changing sector.