Search results for "qbd"

Article Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
…a per product qualitative and semi-quantitative business case for application of quality-by-design (QbD) for a biopharmaceutical product. Previous authors have not frequently approached the business …

Article Regulatory Challenges in the QbD Paradigm
Implementation of quality by design (QbD) in this environment has further contributed to the need to clarify what information needs to be included in a regulatory filing and how it should be presented…

Article QbD and PAT in Upstream and Downstream Processing
UPSTREAM PROCESSING BioPharm: In implementing QbD, what would you identify as the critical quality attributes (CQAs) in a typical upstream bioprocess using cell-culture? Vanden Boom (Hosp…

Article A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
How as QbD evolved over the years? Dr. Rathore: QbD is now in more mature state. The period of 2005-2008 was more about the industry and academia trying to understand what QbD is and what the unde…

Article Implementing QbD in Sterile Manufacturing
Critical quality attributes  BioPharm: In implementing a QbD approach, what would you identify as the critical quality attributes (CQAs) in sterile manufacturing and aseptic processing? …

Article Advancing QbD in the EU
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD) concepts over the past 10 years. In 2003, EMA set up a team to back activities in pro…

Article A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
Is QbD activity company-wide or occurring within smaller groups in the company? QbD implementation started off as something that smaller groups would get involved with. However, as these concepts h…

Article QbD Improves Cell-Culture Process Control
However, using a quality-by-design (QbD) approach that employs predictive modeling can improve the quality of end product as well as the efficiency of the bioprocess. Real-time quality control …

Article FDA and EMA Extend QbD Parallel-Assessment Pilot Program
In the joint pilot program, which began in March 2011, FDA and EMA agreed to share knowledge, ensure consistent adherence to international guidelines related to QbD and promote the availability of pha…

Tip QbD or not QbD? That is not the question
Quality-by-design principles are here to stay and the real issue is how to apply them to achieve better robustness and economy without a lot of extra time and work. High-throughput methods are essen…

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