Search results for "qbd"
Article
Quality by Design and Extractable and Leachable Testing
…r and resembles a “quality-by-QC test” strategy, rather than a more sensible quality-by-design (QbD) strategy that is expected today. If harmful leachables are found during stability studies, one wou…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The concept of quality by design (QbD) was introduced to the pharmaceutical industry in the International Conference on Harmonization (ICH) guidance documents, ICH Q8-Q11 (1-4), as a way to develop ro…
Article
Continued Process Verification for Biopharma Manufacturing
CPV and Quality by Design
Quality by design (QbD) means scientifically building quality into a product and the process by which it is developed and manufactured. QbD is based on the systematic ide…
Article
The Need for Advanced Process Modeling for New Therapeutic Biologics
FDA’s quality-by-design (QbD) and validation initiatives also encourage the use of modeling early on.
While QbD does not define manufacturing design space or specific protocols, it does discuss…
Article
Critical Quality Attributes Challenge Biologics Development
Challenges for biologics
BioPharm: Are there specific challenges to identifying CQAs in biologics when applying quality by design (QbD)?
Das (BMS): Knowledge-based design, as opposed to a heur…
Article
What Drove Biopharma Development in 2014?
One of them is Quality-by Design (QbD). As federal agencies continue to push for proof of quality in biologics, there is increased interest in, and use of, QbD in pharmaceutical development and that t…
Article
Assessing Manufacturing Process Robustness
…es and equipment
validation of analytical methods per analytical quality by design (QbD) as per ICH Q 14
utilization of cumulative data from all relevant studies to es…
Article
Quality Systems Key to Lifecycle Drug Management
FDA officials have long proposed that manufacturers implementing quality-by-design (QbD) approaches and quality controls should be able to manage postapproval changes with less regulatory oversight. T…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
…excipients and complex dosage forms, and process analytical technology (PAT) and quality-by-design (QbD) approaches. What does FDA and the industry hope to gain by focusing on these areas?
…