Search results for " QbD"
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Quality by Design and Extractable and Leachable Testing
FDA Guidance for Industry, Q8 (R2) Pharmaceutical Development describes the elements of QbD used in pharmaceutical development (2). The guidance outlines a series of proactive steps used to build qual…
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Using Quality by Design to Develop Robust Chromatographic Methods
In 2010, the European Federation of Pharmaceutical Industries and Associations (EFPIA) Subteam on Analytical Methods introduced the concept of applying QbD principles to analytical methods (5) where t…
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Continued Process Verification for Biopharma Manufacturing
By providing the mechanism for ongoing acquisition of process knowledge, CPV provides an optimal mechanism for achieving the goal of measuring process performance and, therefore, fits well within the …
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The Need for Advanced Process Modeling for New Therapeutic Biologics
While QbD does not define manufacturing design space or specific protocols, it does discuss the need for a systematic approach to drug development and manufacturing. FDA believes that a QbD approach, …
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Critical Quality Attributes Challenge Biologics Development
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Das (BMS): Knowledge-based design, as opposed to a heuristic approach, is a key principle of QbD. Determination of criticality of process and quality attributes improved significantly in the …
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What Drove Biopharma Development in 2014?
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 trend is only expected to rise. According…
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Assessing Manufacturing Process Robustness
Data gaps identified at Stage 1 QbD, Stage 2 equipment/facility/utility qualification and PPQ, and Stage 3 continued process verification require that a sampling and testing plan be developed under a …
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Quality Systems Key to Lifecycle Drug Management
FDA officials plan to try again to offer regulatory relief in filing supplements and also in undergoing plant inspections for those biopharma companies that implement QbD and advanced manufacturing te…
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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…
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A Look Ahead at BioPharma Manufacturing and Regulation
By applying QbD and understanding the role of excipients and complex dosage forms, a higher level of product and process understanding will be obtained. The other approaches (PAT, continuous manufactu…