Yu Lawrence X
Food and Drug Administration, Office of Generic Drugs, 7519 Standish Place, Rockville, Maryland 20855, USA.
Pharm Res. 2008 Apr;25(4):781-91. doi: 10.1007/s11095-007-9511-1. Epub 2008 Jan 10.
The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality.
The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone.
The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time.
Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.
本文旨在探讨药品质量源于设计（QbD），并描述其如何用于确保药品质量。
对QbD进行了描述，并确定了其一些要素。在固体口服制剂生产过程中，为每个单元操作确定了工艺参数和质量属性。将QbD的使用与单纯通过测试评估产品质量进行了对比。
QbD是一种药品研发的系统方法。它意味着设计和开发制剂及生产工艺以确保预定的产品质量。QbD的一些要素包括：定义目标产品质量概况；设计产品和生产工艺；识别关键质量属性、工艺参数和变异性来源；控制生产工艺以长期生产出质量一致的产品。
通过使用QbD，通过理解和控制制剂及生产变量来确保药品质量。产品测试确认产品质量。实施QbD将使简化新药申请（ANDAs）的化学、生产和控制（CMC）审评转变为基于科学的药品质量评估。
