Quality by Design is a concept first outlined by quality expert Joseph M. Juran in publications,
most notably Juran on Quality by Design. Juran believed that quality could be planned, and
that most quality crises and problems relate to the way in which quality was planned.
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 as a vehicle for the transformation of how drugs
are discovered, developed, and commercially manufactured.
Pharmaceutical Quality by Design The FDA imperative is outlined in its report
“Pharmaceutical Quality for the 21st Century: A Risk-Based Approach.” In the past few
years, the agency has implemented the concepts of QbD into its pre-market processes. The
focus of this concept is that quality should be built into a product with an 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 QC" approach that the companies have taken up
until the 1990s. The QbD initiative, which originated from
the Office of Biotechnology Products, attempts to provide guidance on pharmaceutical development
to facilitate design of products and processes that maximizes the product’s efficacy and
safety profile while enhancing product manufacturability. QbD activities within FDA
The following activities are guiding the implementation of QbD:
In FDA’s Office of New Drug Quality Assessment, a new risk-based pharmaceutical quality assessment
system 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. Implementation of a Question-based Review
Process has occurred in CDER's Office of Generic Drugs.
CDER's Office of Compliance has played a role in complementing the QbD initiative by optimizing
pre-approval inspection processes to evaluate commercial process feasibility and determining
if a state of process control is maintained throughout the lifecycle, in accord with the
ICH Q10 lifecycle Quality System. First QbD Approval - including design space
- for Biologic License Application is Gazyva While QbD will provide better design predictions,
there is also a recognition that industrial scale-up and commercial manufacturing experience
provides knowledge about the process and the raw materials used therein. FDA's release
of the Process Validation guidance in January 2011 notes the need for companies to continue
benefiting from knowledge gained, and continually improve throughout the process lifecycle by
making adaptations to assure root causes of manufacturing problems are corrected.
ICH activities Working with regulators in the European Union
and Japan, FDA has been furthered Quality by Design objectives through the International
Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human
Use. ICH guidelines Q8, Q9, and Q10 provide some assistance for manufacturers to implement
Quality by Design into their own operations. The ICH Steering Committee meets twice a year
to discuss the progress of its efforts. This practical input should help ensure that quality
risk management and knowledge management are used to make lifecycle adaptations that maintain
process control and product quality. See also
Laboratory quality control Quality control
International Society for Quality Electronic Design
References
8. Joseph M. Juran, a perspective on past contributions and future impact, Quality and
Reliability Engineering International, Vol. 23, pp. 653–663, 2007 by Godfrey, A.B.
and Kenett, R.S. 9. Quality by Design Applications in Biosimilar
Technological Products, ACQUAL, Accreditation and Quality Assurance, Springer Verlag, Vol.
13, No 12, pp. 681–690, 2008 by Kenett R.S. and Kenett D.A.
External links Implementing Quality by Design, by Helen Winkle,
FDA Implementation of QbD Principles in CMC Review,
by Chi-Wan Chen, PhD, Deputy Director, Office of New Drug Chemistry
Quality-by-Design Case Studies in Pharmaceuticals and Biologics