Issue link: http://www.e-digitaleditions.com/i/579724
Inhalation OCTOBER 2015 11 Quality by design: Considerations for inhalation product development Getting a drug onto the market is a long, complex and costly process. Companies developing new ther- apeutics and formulations must be able to make the process as simple and efficient as possible. Quality by design, or QbD, is an approach that could help, by putting the focus on commercialization right from the early steps of the product development process, and ensuring that it is maintained and moni- tored throughout. 1 However, QbD also brings the challenge of securing a budget, and planning for more extensive and earlier product and process experiments than might have typically been consid- ered in a more traditional approach to product development. While any additional development costs may be offset by a smoother and quicker review of regulatory filings and the increased relia- bility of the manufactur ing process br inging reduced costs post-commercialization, the move- ment of cost from post-registration batch product learning and process refinement to pre-approval product development may be challenging in light of the uncertainty of a successful clinical program. While the QbD process has already been used in the development of a wide range of dosage forms, there has so far been little focus on its use with inhaled drugs and their associated devices, includ- ing pressurized metered dose inhalers (pMDIs) and dry powder inhalers (DPIs). This article will look at how QbD can be built into product development to ensure the end results are a drug and device that are both safe and effective. It will also show that the process of building in QbD has the potential to improve a product's success. What is quality by design? Quality by design was a concept developed by the engineer Joseph M. Juran, who believed that quality could be planned. 2 It is a concept that can be (and is) built into the design and manufacturing process in many different industries, including pharmaceu- tical manufacturing. The QbD process includes ele- ments such as target product profiles, control strate- gies built on assessment of quality attributes and risk assessment, and experimental design space which supports continuous improvement and life- cycle management. 3-5 The European Medicines Agency (EMA) defines QbD as "an approach that aims to ensure the qual- ity of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines." 6 One of the drivers behind the introduction of QbD was the FDA's observation that manufacturers were becoming increasingly wary of using new processes and technologies that had the potential Carole Evans, PhD, Lei Mao, PhD and Elanor Pinto, PhD Catalent Pharma Solutions Concepts to simplify the complexity