Statistical Thinking and Knowledge Management for Quality-Driven Design and Manufacturing in Pharmaceuticals

被引：0
作者：
Evdokia Korakianiti
Dimitrios Rekkas
机构：
[1] Quality Sector,European Medicines Agency
[2] Chemicals,School of Pharmacy, Division of Pharmaceutical Technology
[3] University of Athens,undefined
来源：
Pharmaceutical Research | 2011年 / 28卷
关键词：
design of experiments; knowledge management; process analytical technologies; process variability; quality; quality by design; statistical process control and analysis; statistical thinking;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
The purpose of this article is to present the evolution of quality principles and how they have been implemented in the pharmaceutical industry. The article discusses the challenges that the FDA PAT Guidance and the ICH Q8, Q9 and Q10 Guidelines present to industry and provides a comprehensive overview of the basic tools that can be used to effectively build quality into products. The principles of the design of experiments, the main tools for statistical process analysis and control, and the requisite culture change necessary to facilitate statistical, knowledge-based management are also addressed.
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页码：1465 / 1479
页数：14
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