设计质量
关键质量属性
计算机科学
质量(理念)
医药制造业
过程(计算)
产品(数学)
工艺验证
风险分析(工程)
生化工程
制造工程
工艺设计
产品设计
工艺工程
系统工程
新产品开发
工程类
运营管理
过程集成
业务
数学
验证和确认
操作系统
认识论
哲学
营销
生物
生物信息学
几何学
作者
Suryakanta Swain,Rabinarayan Parhi,Bikash Ranjan Jena,Sitty Manohar Babu
出处
期刊:Current Drug Discovery Technologies
[Bentham Science]
日期:2019-10-14
卷期号:16 (3): 240-250
被引量:18
标识
DOI:10.2174/1570163815666180308142016
摘要
Quality by Design (QbD) is associated with a modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also lead to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify the desired and required product performance report, such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA).This review highlighted the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected thus, consistently manufacturing the required product. Risk assessment tools and design of experiments are its prime components.This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized.This article provides a complete data as well as the roadmap for universal implementation and application of QbD for pharmaceutical products.
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