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