Real Lean Transformation

Case Studies

Biologics Drug substance and Drug product ›

This project was targeted to improve the speed, quality and productivity of the QC functions at individual sites to contribute to a more stable supply of product. Additionally, it focussed on development of a standard capacity planning tool and process to provide visibility of resources at the site and network level.


Nutrition ›

The objective of this program was to improve laboratory efficiency and effectiveness through the utilization of lean tools and principles. It covered a range of GMP laboratory types including analytical chemistry, microbiology, environmental monitoring, incoming materials and in process control.


Active Pharmaceutical Ingredient (API) ›

Reduce the overall lead time from manufacture of the product to final release (Quality Control and Quality Assurance).


Contract Research Organization (CRO) ›

Our client, a leader in the third-party contract testing field engaged us to improve the throughput time from sample receipt to COA approval. This environment is quite a challenging one given the paucity of forecast data and the need for a dynamic, flexible workforce to meet challenging customer turnaround times. Additional foci of the project included the creation of standardized roles and a robust and consistent capacity planning process.


Solid Dose (Small Molecule) Pharmaceuticals ›

The primary objective of this project was to reduce batch record review and disposition times to facilitate accelerated release of product to market. Ancillary objectives included increasing QA team productivity through implementation of capacity planning and standard work and streamlining of deviation management processes.