Quality by Design

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 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.
Dec 02, 2017
Pharmaceutical Technology
A QbD approach can address manufacturing complexities in transdermal patch manufacturing.
Dec 02, 2017
Pharmaceutical Technology
Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.
Oct 19, 2017
By Pharmaceutical Technology Editors
How soon could the pharmaceutical industry see a widespread adoption of emerging technologies that are poised to shape its future?
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