13 QBD理念的关键——设计空间. 设计空间（ Design space ）：是已被证明有质量保障作用的物料变量和工艺参数的多维组合和交互作用. 知识空间：CQAs与物料属性和工艺参数的关系. 14 设计空间的确定. 14.1 先申请原则

2015年10月1日 · Identify a CQA based on the severity of harm to a patient (safety and efficacy) resulting from failure to meet that quality attribute. QbD for ANDAs: An Example for IR Dosage Forms. April 2012.

2023年6月8日 · QbD理念应用于原料药生命周期的各环节，对于原料药研发、生产和监管提供了有效路径和方法，是遵守药品生产管理规范（cGMP）的内涵体现。 2.1工艺设计阶段

2017年6月24日 · 关键质量属性（Critical Quality Attributes, CQA）： 指物质（药品或活性成分）具备的直接或间接影响物质安全、鉴别、强度、纯度的物理，化学，微生物方面特性。

2014年12月31日 · Quality Target Product Profiles (QTPP) are patient and clinical outcome metrics. Critical Quality Attributes (CQA) are drug product/substance quality metrics. Even to this day, few QbD case studies make this distinction clearly. QbD began in order to provide quality drugs to the patients.

2022年11月15日 · QbD以预先设定的目标产品质量特性作为研发的起点，在了解关键质量属性（CQA, Critical Quality Attribute）的基础上，通过实验设计的方法，识别出影响产品CQA的关键工艺参数（CPP, Critical Process Parameters），并建立相应参数的设计空间。

QBD – Quality by Design. In a QBD approach to manufacturing a pharmaceutical product, you consider the quality of the product at the earliest possible stage rather than simply testing the product for quality towards to the end. In practice, this means identifying the sources of variability that could possibly affect a process.

CQA assessment – CQA impact on safety & efficacy is independent of process capability, process changes shouldn’t impact QA criticality – makes CQA assessment more modular. Using quality attribute criticality for: •Prioritization in QbD cell line & process development •clone and process selection establishing and justifying analytical ...

QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process ...

什么是 关键质量属性 （CQA）？ 质量源于设计 (QbD) 是一套系统的、 基于充分的科学知识和质量风险管理的研发方法， 从预先确定的目标出发，强调对产品和工艺的理解以及工艺控制。对疾病状态和药物分子属性，对生物学作用机制及安全性影响的全面认识是QbD ...