Quality by design
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Quality by Design (QbD) is a concept first outlined by well-known quality expert Joseph M. Juran in various publications, most notably Juran on Quality by Design. [1]. Juran believed that quality could be planned, and that most quality crises and problems relate to the way in which quality was planned in the first place.
While Quality by Design principles have been used to advance product and process quality in every industry, and particularly the automotive industry, they have most recently been adopted by the U.S. Food and Drug Administration (FDA) as a vehicle for the transformation of how drugs are discovered, developed, and commercially manufactured.[2] [3]
Pharmaceutical quality by design
This FDA imperative is best outlined in its report “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach.”[4] In the past few years, the Agency has made significant progress in implementing the concepts of "Quality by Design" (QbD) into its processes. The focus of this concept is that quality should be built into a product with a thorough understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks. This is a successor to the "quality by inspection" (or "quality after design") approach that the FDA has taken until the late 1990s/early 2000s.
QbD activities within FDA
Specifically, the following activities are guiding the overall implementation of QbD:
- In FDA’s Office of New Drug Quality Assessment (ONDQA), a new risk-based pharmaceutical quality assessment system (PQAS) was established based on the application of product and process understanding.
- Implementation of a pilot program to allow manufacturers in the pharmaceutical industry to submit information for a new drug application demonstrating use of QbD principles, product knowledge, and process understanding. In 2006, Merck & Co.’s Januvia became the first product approved based upon such an application.[5][6]
- Implementation of a Question-based Review (QbR) Process has occurred in CDER's Office of Generic Drugs.
- CDER's Office of Compliance has played an active role in working with the field to develop appropriate pre-approval inspectional processes for QbD and implementation of lifecycle Quality Systems under ICH Q10.
- Implementation of QbD for a Biologic License Application (BLA) is progressing.
ICH activities
Working with regulators in the European Union (the European Medicines Agency) and Japan, FDA has been instrumental in furthering Quality by Design objectives through the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH guidelines Q8 (on Pharmaceutical Development), Q9 (on Quality Risk Management), and Q10 (on Pharmaceutical Quality System) provide some assistance for manufacturers to implement Quality by Design into their own operations. [7] The ICH Steering Committee meets twice a year to discuss the progress of its efforts. Further details are being developed by industry organizations to assure these objectives are met by application of innovations and evolved process understanding throughout the process lifecycle. This practical input should help ensure that quality risk management and knowledge management are used to make necessary lifecycle adaptations that maintain process control and product quality, including rapid corrective and preventative action (CAPA) to assure sustainable CGMP compliance.
References
- ^ Juran, J.M.: “Juran on Quality by Design”, Google Books
- ^ Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control
- ^ Roadmap for implementation of quality by design (QbD) for biotechnology products
- ^ Pharmaceutical Quality for the 21st Century: A Risk-Based Approach http://www.fda.gov/oc/cgmp/report0507.html
- ^ FDA Approves New Treatment for Diabetes http://www.fda.gov/bbs/topics/NEWS/2006/NEW01492.html
- ^ Patricia Tway: Why QbD Worked for Januvia http://www.pharmaqbd.com/?q=node/133
- ^ ICH Quality Guidelines http://www.ich.org/cache/compo/276-254-1.html
See also
External links
- Pharmaceutical Quality by Design: Improving Emphasis on Manufacturing Science in the 21 st Century, by Ajaz Hussain, PhD (formerly of FDA)
- Engineering a Proactive Decision System for Pharmaceutical Quality, by Ajaz Hussain, PhD (formerly of FDA)
- Implementing Quality by Design, by Helen Winkle, FDA
- Role of Statistics in Pharmaceutical Development Using Quality-by-Design Approach – an FDA Perspective
- Pharmaceutical Quality by Design: One In a million: Guiding the Adult Stem Cell, by Agnes Shanley, Editor in Chief
- Implementation of QbD Principles in CMC Review, by Chi-Wan Chen, PhD, Deputy Director, Office of New Drug Chemistry
- ICH Q9 Briefing Pack