Department of Formulation Sciences, Biopharmaceutical Development, MedImmune, One MedImmune Way, Gaithersburg, Maryland, 20878.
J Pharm Sci. 2013 Nov;102(11):3883-7. doi: 10.1002/jps.23703. Epub 2013 Aug 14.
The application of key elements of quality by design (QbD), such as risk assessment, process analytical technology, and design space, is discussed widely as it relates to freeze-drying process design and development. However, this commentary focuses on constructing the Design and Control Space, particularly for the primary drying step of the freeze-drying process. Also, practical applications and considerations of claiming a process Design Space under the QbD paradigm have been discussed.
本文广泛探讨了质量源于设计（QbD）的关键要素的应用，如风险评估、过程分析技术和设计空间，因为这些要素与冷冻干燥工艺的设计和开发密切相关。然而，本文评论的重点是构建设计和控制空间，特别是针对冷冻干燥工艺的初级干燥步骤。此外，还讨论了在 QbD 范式下声称工艺设计空间的实际应用和考虑因素。
