This paper places the “Quality by Design” (QbD) in an overall context and provides the following straightforward definition so that QbD can be effectively used to solve a wide variety of important problems:
Quality by Design–During the design stage, to achieve a well-defined goal, iteratively apply science and engineering methods to anticipate, identify, understand, resolve, and control problems that will be encountered during testing, operating, and verifying the goal over its lifecycle.
The viewpoint of the paper is to view QbD as “Success by Design.” The definition is based on answering the following question: What will be required to provide assurance that the enabler developed during the design stage will successfully reach the goal over the entire lifecycle before leaving the design stage? The paper argues that QbD should not be implemented as a program, but used as a tool. To provide understanding, the paper explores underlying concepts, the history of QbD, develops a working definition, and then applies it to biopharmaceutical development and manufacturing…
Tag: <span>quality by design</span>
This article proposes a “design space” structure for using Quality by Design (QbD) to develop processes and control strategies for developing and manufacturing biopharmaceuticals…
This paper examines FMEA as a QbD tool. If FMEA’s strengths are used and weaknesses understood, it can be effectively used within a QbD feedback algorithm to identify, analyze, prioritize, and remediate biopharmaceutical development and manufacturing risks…
This paper describes how a biopharmaceutical product development effort can be structured to identify, understand, and plan activities and goals required to efficiently and rapidly deliver new products and therapies to patients. Although the paper focuses on manufacturing, the approach can be used for all aspects of pharmaceutical product development from establishing an intellectual property position, developing a comprehensive manufacturing plan, to creating a marketing program…
The current draft of ICH Q12 appears to have taken several steps backward in the pursuit of the manufacturing excellence initiated by ICH Q8 (R2) pharmaceutical development and expanded by FDA’s 2011 process validation guidelines…
Achieving very high levels of pharmaceutical product quality, particularly for the next generation of biologics, will require proactive use of a broad range of quality and process development tools throughout the therapeutic’s development and manufacturing lifecycle. These tools are most effective when integrated using an expanded form of FDA’s 2011 process validation guidelines. This article explains how process validation can be combined with quality by design (QbD), ICH Q8 design space (DS) and control strategies (CS), process analytical technology (PAT), and quality risk management (QRM) tools to provide a path to manufacturing very high-quality products. The approach establishes clear goals and then proactively builds appropriate control systems during process development to assure continuous control and verification of all manufacturing activities. Prospectively using the tools over the complete manufacturing lifecycle, from preclinical through commercial manufacturing, is particularly important to assure comparability from early product research and development all the way to commercialization. The continued evolution of these quality tools, as well as building new tools, will provide a path for the pharmaceutical industry to reach and maintain Six Sigma levels of product quality…