Case Studies

Master Batch Record (MBR) Generation, Review and Approval in a CDMO Environment

Our Client, a large contract development and manufacturing organisation (CDMO) engaged us to support an extensive end to end order fulfilment project with the objective of significantly improving OTIF delivery performance.

Multi Product and Multi Presentation

The focus of this project was to address long and inconsistent lead-times for the release of product. The lab faced a particular challenge in the volatility of both mix and volume of workload.

Pharmaceutical Packaging Operation

This project was targeted to improve delivery performance (OTIF) to customer base, optimize capacity & productivity in the packing operation, provide improved visibility of upcoming workload for support functions such as QC & QA, and to re-engineer the planning process.

Environmental Monitoring

Our client, a leading pharmaceutical company, engaged us to help reduce their substantial overtime spending.

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.

Biopharmaceutical Research & Development

Our client, a leading pharmaceutical company, engaged us to increase project workload capacity at their Research & Development (R&D) facility whilst improving the schedule adherence of current project workloads. The project was charged with optimizing and increasing the utilization of advanced bioreactor laboratories, at a site that was responsible for the development of the next generation analogues of a portfolio of biological derived (large molecule) drugs, including one $6 billion/year blockbuster.

Nutraceuticals

This project was targeted to improve the speed, quality and productivity of the QC function at a site manufacturing nutrition premixes. Additionally, it focused on development and installation of a standard performance management process.

FMCG

The purpose of the program was to improve overall laboratory performance in the areas of quality, productivity and analyst engagement. Targets were specific to individual sites, dependent on complexity and level of lean maturity. A further aim of the program was to improve communication with and visibility to global functions of operational performance.

Generics

The focus of this project was to improve throughput times from sample receipt through testing and review. An additional objective was to increase right the first time for test execution and decrease time samples spend in review.