Quality System Optimization is a suite of professional services for the process validation of online TOC analyzers for real time pharmaceutical water release and process control.
Quality System Optimization (QSO)
Pharmaceutical manufacturers are under increasing economic regulatory and economic pressure to improve quality and streamline processes. Regulatory authorities have issued guidelines supporting real-time process control and measurement as a way to achieve these goals. For water quality testing, moving from laboratory-based TOC instruments to on-line TOC measurement offers significant benefits. Real-time release (RTR) testing of pharmaceutical water using on-line instruments can reduce costs, produce higher quality analytical reults, and enhance process understanding.
A Risk-Based, Scientific Approach to Implementing Real-time Release of Pharmaceutical Water
To help companies make this transition, GE Analytical Instruments offers the program, Implementing On-Line TOC for Real-Time Water Release, which is part of GE Analytical Instruments’ Quality System Optimization (QSO)™ service offering. For short, the RTR program is called QSO/RTR. QSO/RTR provides a risk-based, scientific framework for moving TOC testing from the laboratory to the production floor. It incorporates Lean manufacturing and Six Sigma® best practices, aligned with current Good Manufacturing Practices (cGMPs) and regulatory guidance. QSO/RTR provides a practical roadmap on how to evaluate variability and identify opportunities for improvement in TOC sample analysis processes. This program simplifies and accelerates this traditionally complex and lengthy transition. It is designed to be implemented in six months or less.
QSO/RTR Program Components
The QSO/RTR program has four main components:
- Validation documentation
- Validation services
- Consulting
- One-day introductory workshop
Each component is available separately or as part of the complete QSO/RTR program.
Find Out More about QSO/RTR
To learn how your company could benefit from the Quality System Optimization/RTR program, please contact your sales representative or click here.