Quality by Design

Jun 02, 2018
Pharmaceutical Technology
Quality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product’s lifecycle.
Jun 02, 2018
Pharmaceutical Technology
Dissolution testing remains one of the pharmaceutical industry’s most straightforward, least expensive QC tools. Research is focusing on ways to extend its reach, improve in-vitro and in-vivo correlation, and make real-time release testing a reality.
Apr 02, 2018
Pharmaceutical Technology
Taking vendor product data at face value puts pharmaceutical manufacturers and their supply chain partners at risk.
Mar 19, 2018
By Pharmaceutical Technology Editors
Sartorius Stedim Biotech has launched a new automated parallel bioreactor system for perfusion culture.
Mar 06, 2018
Twenty-first century drug development challenges sponsors and contract partners to collaborate more closely, using tools such as model-based simulation.
Mar 02, 2018
Pharmaceutical Technology
This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.
Mar 01, 2018
Pharmaceutical Technology
Tableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.
Feb 01, 2018
Pharmaceutical Technology
Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.
Jan 02, 2018
Pharmaceutical Technology
A new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation.
Dec 02, 2017
Pharmaceutical Technology
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.
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