Quality by design

The Juran Trilogy Juran's process seeks to create features in response to understanding customer needs. These are customer-driven features. The sum of all features is the new product, service, or process. The quality by design model consists of the following steps: • Establish the project design targets and goals. • Define the market and customers that will be targeted. • Discover the market, customers, and societal needs. • Develop the features of the new design that will meet the needs. • Develop or redevelop the processes to produce the features. • Develop process controls to be able to transfer the new designs to operations. In addition to organizational integration, a successful team must begin with clearly articulated common goals for the product that are measurable and authorized by the enterprise. These goals must, at a minimum, cover such elements as: • The customers or customer segments to be served by the new product • The relative and absolute quality goals • The volume of sales or revenue to be generated in an initial time period and for the long run • Market share, penetration, or sales relative to key competitors • The release date The team will follow a structured process. The structure is the common framework for all participants in launching the new product and helps ensure success. Control over variation and transfer to operations Quality by design incorporates modern tools to preemptively control variation. These tools and methods begin by measuring and understanding the variation that exists by using historical data, testing, and modeling to help forecast, analyze, and eliminate the deleterious effects of variation using standard statistical techniques. Process control consists of three basic activities: • Evaluate the actual performance of the process • Compare actual performance with goals • Take action on the difference The final activity of the quality by design process is to implement the plan and validate that the transfer has occurred. ==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" (or "quality after design") approach that the companies have taken up until the 1990s. • Implementation of a Question-based Review (QbR) 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 (BLA) is Gazyva (Roche) 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 (the European Medicines Agency) and Japan, the FDA has furthered quality by design objectives through the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The ICH Guidelines Q8 through Q11 encapsulate these unified recommendations and provide some assistance for manufacturers to implement quality by design into their own operations. ICH Guideline Q8 describes QbD-based drug formulation development and was first published in 2004, being subsequently revised in 2008 (Q8(R2)). The ICH Guideline Q9 describes Quality Risk Management plans, Q10 explains Pharmaceutical Quality Systems, and Q11 refer to the development of active pharmacological substances including biologicals. In November 2017, the ICH issued Guideline Q12 for public consultation to extend the recommendations for the Product Lifecycle Management Plan that were initially defined in the Guideline Q10. According to the ICH, Guideline Q13 will extend the previous guidelines to accommodate continuous pharmaceutical manufacturing and Q2 (Analytical Validation) will be revised and extended into the guideline Q2(R2)/Q14 to include Analytical quality by design or AQbD. 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==