Abstract
The elements of quality by design are examined and a consistent nomenclature for quality by design, critical quality attribute, critical process parameter, critical material attribute, and control strategy is proposed. A process is well understood when all critical sources of variability are identified and explained, variability is managed by the process, and product quality attributes can be accurately and reliably predicted over the design space. Quality by Design (QbD) is a systematic approach to development of products and processes that begins with predefined objectives and emphasizes product and process understanding and process control based on sound science, statistical methods and quality risk management. In an attempt to curb rising development costs and regulatory barriers to innovation and creativity, the FDA and ICH have recently started promoting QbD in the pharmaceutical industry [1, 3, 7,]. QbD is partially based on the application of multivariate statistical methods [2, 4, 6] and a statistical Design of Experiments strategy [4, 5, 6] to the development of both analytical methods and pharmaceutical formulations. The talk will review the basics of QbD with case studies from the pharmaceutical industry
Highlights
As the industry focuses on better manufacturing efficiency, there is greater interest in identifying powder properties that directly influence tabletting in-process performance and final product quality
Quality by Design (QbD) calls for product quality to be 'designed in' rather than tested for in postproduction
Pharmaceutical industry's ability to understand how bulk powder properties impact process behavior has been constrained by a lack of reliable bulk powder property data
Summary
As the industry focuses on better manufacturing efficiency, there is greater interest in identifying powder properties that directly influence tabletting in-process performance and final product quality. Particle-size distribution is a critical primary particle characteristic of powders, but it is only one of many variables that impact bulk powder properties, which in turn dictate in-process behaviour and product quality[1]. Tablet production can be divided into at least four discrete processes : Each of these processes subjects the powder to a specific set of environmental conditions (e.g., flow rates, stresses, Nwoko Valentine E / International Journal of Advances in Pharmaceutics 2 (2) 2013 and equipment surface properties), making different bulk properties more relevant at different stages. Shape information was gathered by microscopy, but the advent of automated imaging has made it much faster and easier to access statistically relevant data Such information forms a foundation for scientific investigation of the impact of shape and supports the development of more successful tabletting blends
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
