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#5 Lean laboratory

Lean principles can work in any laboratory environment, including pharmaceutical, medical, and chemical manufacturing laboratories. 


This article shows how, through some exemplary applications in pharmaceutical QC labs.

Pharmaceutical manufacturers continue to operate in an increasingly competitive environment, contending with issues that run the gamut from lost revenue as patents have expired, ballooning costs for new drug research and development, changes required by new regulations, and global market pressures to reduce costs and improve quality and delivery.

The quality control (QC) laboratory plays a critical role in pharmaceutical production, for both in-process and finished product testing. Labs not only monitor and control the quality of incoming APIs (active pharmaceutical ingredients), and other supplies used in the manufacturing process; they are also instrumental in the batch release process.

As a result, steady pressure is on to improve operations in pharmaceutical QC labs. In general, the challenge boils down to this: finding a way to improve capacity and utilization of resources, reduce lead times while increasing reliability, and speed up the authorizations necessary for both production and batch release.

Lean thinking provides useful ways to address the challenge. However, while lean has been used extensively in many discrete and process manufacturing industries, laboratories have lagged behind in applying lean principles. But they are starting to catch up. This article covers some ways they are doing just that.



The qc laboratory environment

Like many service operations, lab processes are mostl intangible, and take place in a black box.

QC laboratories play a crucial role in the manufacturing value stream for pharmaceutical products. But lab environments have their own special characteristics. In fact, labs share many aspects of both manufacturing and service operations, in a unique combination.

Labs are like super-clean manufacturing environments, where significant attention must be paid to both safety and compliance. Equipment is often highly sophisticated, extremely sensitive, and very expensive, and proper operations and maintenance are essential to avoiding equipment breakdowns.

Labs are internal suppliers to the pharmaceutical manufacturing process, but like many service operations, their processes and «products»—timely test results—are mostly intangible and invisible in comparison with those of manufactured goods. Processes often take place in a «black box.»



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