Tunnell has been involved in thousands of successful projects. Here is a sampling of the accomplishments many companies have been able to achieve using our proven methodologies and best practices.
The company’s financial success was dependent on placing these drug products into the market place as soon as possible.
For a successful outcome, it was instrumental to not only identify problems but to identify and implement corrective actions to resolve the underlying problems.
A culture of continuous improvement and optimization was achieved along with a definitive understanding what it means to be “inspection ready” at all times.
A Tunnell ‘core’ team of functional area SMEs conducted a rapid risk assessment and developed a detailed implementation plan for the qualification, start up and licensure of that facility (four production lines).
The manufacturer had been cited on several 483’s for inadequate analytical method validation.
Results led to marked improvement in throughput and a significant decrease in investigations.
QUALITY, REGULATORY, COMPLIANCE
Over 8500 SOPS reviewed and revised; approximately 125 SOPs eliminated or streamlined.
LEAN SIX-SIGMA / BUSINESS TRANSFORMATION
Throughout time dropped from 15 days to 8, an improvement of 53 percent.
The client learned how to reduce cycle time without a significant investment.
MANUFACTURING PROCESS IMPROVEMENT
Savings from reduced product loss totaled $850K over a 6-month period.
After the project a sense of urgency was sustained.
Successful product launch with projected $59M sales forecast.