Search results for " QbD"

Article Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
The primary purpose of a quality-by-design (QbD) business case is to demonstrate and elucidate the expected value that QbD is to deliver (2). Lack of belief in QbD's business case has been cited as a …

Article Regulatory Challenges in the QbD Paradigm
FDA has addressed this gap to some extent through its ongoing QbD pilot program, but more guidance is needed from the regulatory authorities to ensure widespread successful implementation of QbD (2). …

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 Addressing the Complex Nature of Downstream Processing with QbD
The International Council for Harmonization (ICH) defines QbD as a systematic approach that incorporates prior knowledge, results of studies using design of experiments (DoE), use of quality risk mana…

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 agency has seen its PAT team as a key element in the implementation of QbD by encouraging process understanding. This knowledge becomes a basis for achieving quality by ensuring pre-defined qualit…

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
Real-time quality control Integrating process analytical technology (PAT) into the bioproduction process enables the biomanufacturer to move from a quality-by-testing approach to a QbD approach, w…

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…

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