The quality-by-design (QbD) approach is widely utilized for developing and validating manufacturing processes for drug substances as well as drug products. This paper discusses the application of the risk-based QbD approach used at F. Hoffmann-La Roche Ltd. for development, optimization, and characterization of drug substance manufacturing processes for small molecules. It presents the evolution of the QbD concept into statistical thinking and development of a quantitative tool, namely, the impact ratio concept, for its successful implementation. The utilization of this approach is illustrated with a case study from the taselisib drug substance manufacturing process.

中文翻译：

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过程表征和过程参数定量关键性评估的 QbD 方法†

质量源于设计 (QbD) 方法广泛用于开发和验证原料药和药品的制造工艺。本文讨论了 F. Hoffmann-La Roche Ltd. 使用的基于风险的 QbD 方法在小分子原料药制造工艺的开发、优化和表征中的应用。它介绍了 QbD 概念向统计思维的演变以及定量工具（即影响比概念）的开发及其成功实施。通过 taselisib 原料药生产过程的案例研究说明了这种方法的利用。