2018年7月30日 · Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on sound science.

2012年8月12日 · It outlines the key elements of QbD including establishing a quality target product profile, identifying critical quality attributes, understanding material attributes and process parameters that impact critical quality attributes through risk assessment, developing a design space, and implementing a control strategy.

QbD can be viewed as a process defined by series of document requirements. These documents organize and demonstrate process knowledge and understanding. QbD can be applied to legacy and new products, but the supporting document package may differ. The QbD suite of documents are “alive”. They can and should be revised as the knowledge base changes.

2020年8月4日 · The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based sound science and quality risk management.

2019年9月6日 · 质量源于设计——QbD;QbD理念的起源;质量概念变迁;QbD概念的提出;基于以上方面考虑，美国FDA在2004年《Pharmaceutical CGMPs for the 21stcentury – A Risk Based Approach》报告一文中正式提出了QbD的概念，并且被人用药品注册技术规定国际协调会议 (Intemational Confcrence on ...

2018年4月27日 · QbD是cGMP 的基本组成部分，是科学的、基于风险的全面主动的药物开发方法，从产品概念到工业化均精心设计，是对产品属性、生产工艺与产品性能之间关系的透彻理解。 QbD体系 实施QbD的步骤 （1）确定产品的关键质量属性，包括理化性质、生物学特性及其他质量相关性质 产品理解 （2）利用风险分析，确定关键工艺参数（Critical Process Parameters，CPP）、起始物料属性与CQA之间的关系； （3）开发出产品生产工艺的设计 …

Quality by Design (QbD) A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.

2020年11月4日，博腾药业研发副总裁赵建先生莅临“2020中国新药CMC高峰论坛”，与数百位来宾共同探讨了“QbD框架下的创新药制剂研发和技术转移”。

2012年1月19日 · Quality by Design (QbD) is a concept first outlined by well-known quality expert Joseph M. Juran who believed that quality could be planned, and that most quality crises and problems relate to the way in which quality was planned in the first place.

6 天之前 · View Quality by Design.ppt from SPS 123 at SOA National Institute Of Law, SOA University, Orissa, Bhubaneswar. Quality by Design: Next Steps to Realize Opportunities? Ajaz S. Hussain, Ph.D. Office of