It’s generally accepted that standard Lean approaches have not been well implemented in the pharmaceutical industry. We feel that this is largely due to a lack of appreciation of the complexities of manufacturing according to cGMP which is a necessity to be in regulatory and quality compliance.
Although many of the basic principles of a Lean philosophy can be applied to the highly regulated Life Science Industry, implementation is often more complex due to the very stringent requirements for thorough and comprehensive documentation and independent quality verification.
What is required in applying Lean to the Life Sciences Industry is a clear understanding of where regulations require commitments and specific actions even though a value stream analysis may show those actions to cause a bottleneck.
Making pharmaceuticals and other Life Science products is a complex marriage of biology, chemistry, engineering and regulatory compliance. Get one of these out of balance and the process will fail for a variety of reasons.
Integration of primary synthesis unit operations with those for recovery, purification and subsequent formulation and final finishing requires many break points, testing points and detailed production records. These are the elements that help define a process and often how this process is operated defines the chemistry and pharmacological activity and utility of the product.
It is these factors that one needs bear in mind when adapting the principles of Lean to the Pharmaceutical and Life Science Industries.
