Making Quality by Design Lean

JMP white paper on a tablet

Quality by Design (QbD) is a method aiming at improving the quality of new products by building quality into the design phase. Notwithstanding the numerous benefits of the approach to the manufacturing industry and the pharmaceutical industry specifically, research shows that the uptake has been surprisingly slow. Having understood the reasons behind the disappointing adoption of the method, and identified complexity as the main one, this paper offers an alternative called Lean QbD.

The proposed methodology’s goal is to understand the process in order to define the design and control spaces which will be used to efficiently and effectively manufacture the product and minimise regulatory risks. Case studies featuring simple guided workflows are used to illustrate how to learn from past work using visualisation and statistics as well as how to increase process understanding with Design of Experiments (DOE). Lean QbD simplifies the process of extracting information from data, and through the use of Monte-Carlo simulations ensures a robust process can be developed and transferred to manufacturing within budget constraints.

*
*
*
*
  我要订阅JMP Newswire,JMP每月新闻通讯。
  是的,你可以不定期地发送JMP相关产品和服务的邮件给我。我可以随时从JMP选择退订邮件。

JMP是SAS Institute Inc的一个事业部,我们将依照SAS隐私声明处理您的信息。

 
 

Back to Top