PAI Readiness For Seven ANDA Products
- PAI Support
The company’s financial success was dependent on placing these drug products into the market place as soon as possible.
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 Preparation and Readiness
- PAI Support
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
- PAI Support
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
- PAI Support
A Tunnell ‘core’ team of functional area SMEs conducted a rapid risk assessment and developed a detailed implementation plan for the qualification, start up
Analytical Method Validation PAI Readiness / Certification
- PAI Support
The manufacturer had been cited on several 483’s for inadequate analytical method validation.
Microbiology Lab Remediation and Process Improvement
- Biotech Support
Results led to marked improvement in throughput and a significant decrease in investigations.
Compliance Remediation
- Quality, Regulatory, Compliance
Over 8500 SOPS reviewed and revised; approximately 125 SOPs eliminated or streamlined.
Lean Lab and Cost Reduction
- LEAN SIX-SIGMA / BUSINESS TRANSFORMATION
Throughput time dropped from 15 days to 8, an improvement of 53 percent.
Manufacturing Capacity Increase via Cycle Time Reduction
- Turnkey Solutions
The client learned how to reduce cycle time without a significant investment.
Manufacturing Process Reliability: Reducing Process Interruptions
- MANUFACTURING PROCESS IMPROVEMENT
Savings from reduced product loss totaled $850K over a 6-month period.
Product Launch Capacity Planning and Modeling for Improved Probability of Success
- MANUFACTURING PROCESS IMPROVEMENT
After the project a sense of urgency was sustained.
Technical Transfer / Consent Decree Remediation
- Technical Expertise
Successful product launch with projected $59M sales forecast.