Project Briefs

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.

PAI SUPPORT
PAI Readiness For Seven ANDA Products

The company’s financial success was dependent on placing these drug products into the market place as soon as possible.

PAI Preparation and Readiness

For a successful outcome, it was instrumental to not only identify problems but to identify and implement corrective actions to resolve the underlying problems.

New Facility Preparation for Pre-Approval Inspection

A culture of continuous improvement and optimization was achieved along with a definitive understanding what it means to be “inspection ready” at all times.

Bio-Facility Qualification, Start-Up & Licensure

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).

Analytical Method Validation PAI Readiness / Certification

The manufacturer had been cited on several 483’s for inadequate analytical method validation.

BIOTECH SUPPORT
Microbiology Lab Remediation and Process Improvement

Results led to marked improvement in throughput and a significant decrease in investigations.

QUALITY, REGULATORY, COMPLIANCE
Compliance Remediation

Over 8500 SOPS reviewed and revised; approximately 125 SOPs eliminated or streamlined.

LEAN SIX-SIGMA / BUSINESS TRANSFORMATION
Lean Lab and Cost Reduction

Throughput time dropped from 15 days to 8, an improvement of 53 percent.

TURNKEY SOLUTIONS
Manufacturing Capacity Increase via Cycle Time Reduction

The client learned how to reduce cycle time without a significant investment.

MANUFACTURING PROCESS IMPROVEMENT
Manufacturing Process Reliability: Reducing Process Interruptions

Savings from reduced product loss totaled $850K over a 6-month period.

Product Launch Capacity Planning and Modeling for Improved Probability of Success

After the project a sense of urgency was sustained.

TECHNICAL EXPERTISE
Technical Transfer / Consent Decree Remediation

Successful product launch with projected $59M sales forecast.