自动化
风险分析(工程)
设计质量
计算机科学
质量(理念)
过程(计算)
质量保证
产品(数学)
可靠性(半导体)
系统工程
管理科学
过程管理
制造工程
工程类
数据科学
运营管理
业务
下游(制造业)
机械工程
哲学
功率(物理)
外部质量评估
几何学
数学
物理
认识论
量子力学
操作系统
作者
Mukesh Maithani,Viney Chawla,Pooja A. Chawla
标识
DOI:10.1007/978-981-16-5180-9_19
摘要
Automation of analytical techniques becomes a necessity both in research and pharmaceuticals manufacturing especially when a large number of analyses have to be carried out as rationally and reliably as possible. With the evolution of technology, there is a simultaneous increase in the levels of quality, safety, and reliability. Additionally, the revolution of the use of computers in pharmaceutical analysis provided by the development of flow analysis concepts and process analysis strategies offer a link between modern instrumentation and social or technological problems. Automation of computer in analysis as well as analytical methodology provides an opportunity to the pharmaceutical industry in its attempts to use risk management and try scientifically designed manufacturing processes. Such attempts often lead to a better understanding of the product and thereby promote quality assurance. With an aim to reduce the increasing costs for product development and to overcome the regulatory hurdles toward invention and creativity, the Federal regulatory agency of the USA, that is, FDA, is promoting automation, and computers are an integral part of achieving this objective. This chapter summarizes current state of automation and computer-aided analysis, computer-assisted analysis of drug delivery systems, different chromatographic data systems, use of computer-/software-assisted analytical method development, role of analytical QbD as well as its application in analytical process, and importance of nanoparticle tracking analysis.
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