Assuring that during routine commercial production, the process remains in a state of control (FDA); involves feedback loops into the QbD “process” where intentional process changes and/or observed variability is assessed for risk, characterized, re-validated, etc.

A comprehensive QbD-based product development strategy was implemented, with the target product profile defined based on the desired product quality of mucoadhesive minitablets.

Quality by design (QbD) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design. [1] Designing for quality and innovation is one of the three universal processes of the Juran Trilogy, in which Juran describes what is required to achieve breakthroughs in new products, services, and ...

QbD fosters product and process understanding and facilitates identification of the sources of variability that impact product quality. Understanding the impact that variability has on in-process materials, downstream processing, and drug product quality provides an opportunity to shift controls upstream and to reduce the reliance on end ...

2016年5月1日 · Here, I present a case study that illustrates the step-by-step development using QbD of a purification process for the production of a biosimilar product: granulocyte colony-stimulating factor (GCSF). I also highlight and discuss the advantages that QbD-based process development offers over traditional approaches.

Quality by Design (QbD), a current trend employed to develop and optimise various critical pharmaceutical processes, is a systematic approach based on the ethos that...

2015年3月1日 · Quality by Design is the modern approach for quality of pharmaceuticals. It describes use of Quality by Design to ensure quality of Pharmaceuticals. In this review, the Quality by Design is...

2021年1月13日 · QbD is defined as a systematic risk-based approach for development that begins with predefined objectives. It focuses on product and process understanding and process control, and is based on sound science and quality risk management [2].

2023年6月17日 · The QbD approach involves understanding the relationship between critical product and process parameters and controlling those parameters to produce a high-quality product consistently. One key aspect of formulation and process development is the use of advanced analytical techniques to understand and control product quality.

2009年8月3日 · This article presents a roadmap for successful QbD implementation for therapeutic biotechnology products. The approach presented here is aligned with existing regulatory guidance documents.