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A perspective on Quality-by-Control (QbC) in pharmaceutical continuous manufacturing
Qinglin Su1, Sudarshan Ganesh1, Mariana Moreno1
1Davidson School of Chemical Engineering, Purdue University, West Lafayette, IN 47907, USA.
Computers & Chemical Engineering
|February 27, 2023
Summary
Quality-by-Control (QbC) enhances pharmaceutical manufacturing by using active process control. This study demonstrates QbC using advanced techniques for robust and efficient continuous manufacturing.
Area of Science:
- Pharmaceutical Manufacturing
- Chemical Engineering
- Process Control
Background:
- The US Food and Drug Administration's (FDA) Quality-by-Design (QbD) guidance promotes pharmaceutical manufacturing modernization.
- Continuous manufacturing adoption is increasing, necessitating advanced process control strategies.
- Active process control has evolved into the Quality-by-Control (QbC) concept.
Purpose of the Study:
- To define and discuss the Quality-by-Control (QbC) concept.
- To review recent developments and challenges in QbC implementation for continuous manufacturing.
- To demonstrate QbC using a pilot-scale continuous direct compaction process.
Main Methods:
- Implementation of Quality-by-Control (QbC) principles.
- Utilizing a pilot-scale rotary tablet press for direct compaction.
- Application of advanced model-based techniques: data reconciliation, model predictive control (MPC), and risk analysis.
Main Results:
- Active process control is essential for comprehensive QbC.
- Model-based techniques, including MPC and risk analysis, are critical for QbC.
- The demonstrated QbC approach ensures robustness and efficiency in continuous manufacturing.
Conclusions:
- Quality-by-Control (QbC) represents a significant advancement in pharmaceutical manufacturing.
- Effective QbC relies on deep product and process knowledge coupled with sophisticated control strategies.
- The study confirms the indispensability of active process control for QbC in continuous manufacturing settings.
Keywords:
Pharmaceutical continuous manufacturingProcess automationProcess controlQuality-by-ControlQuality-by-DesignSystems integrationMore Related Videos
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