Compliance Notes

Jul 01, 2010
BioPharm International
By BioPharm International Editors
By identifying and eliminating non-value-added activities, drug manufacturers can avoid falling into the same cost-traps in the future.
Nov 01, 2009
BioPharm International
By BioPharm International Editors
The focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.
Jul 01, 2009
BioPharm International
By BioPharm International Editors
A culture of quality that emphasizes business objectives, risk management, and the informed application of technology can improve compliance.
Jun 01, 2009
BioPharm International
By BioPharm International Editors
New expression systems compete for attention.
May 01, 2009
BioPharm International
By BioPharm International Editors
Use Lean techniques to improve manufacturing compliance
Jan 01, 2009
BioPharm International
By BioPharm International Editors
QbD can help satisfy FDA and EMEA requirements.
Sep 01, 2008
BioPharm International
By BioPharm International Editors
Every biotech company reaches a point in its development where it must decide what path it will take after it passes the start-up phase. This article discusses what the company must consider to decide what business model it will follow.
Jul 01, 2008
BioPharm International
By BioPharm International Editors
Quality by Design and Design Space can be used by companies to enhance process understanding, improve scientific rigor, and enhanced qualitative and quantative performance, as well as cost savings.
May 01, 2008
BioPharm International
By BioPharm International Editors
The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues. QbD scientifically provides a greater understanding of the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy by determining the various permutations of critical input variables that will keep the product within specification.
Mar 01, 2008
BioPharm International
By BioPharm International Editors
A comprehensive process and analytical transfer package can speed up your product's time to market and save costs.
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