European Medicines Agency, Quality Sector, Chemicals, 7 Westferry Circus, Canary Wharf, E14 4HB, London, UK.
Pharm Res. 2011 Jul;28(7):1465-79. doi: 10.1007/s11095-010-0315-3. Epub 2010 Dec 14.
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.
本文旨在介绍质量原则的演变及其在制药行业中的实施方式。文章讨论了 FDA PAT 指南和 ICH Q8、Q9 和 Q10 指南给行业带来的挑战，并全面概述了可有效将质量融入产品的基本工具。还讨论了实验设计原则、统计过程分析和控制的主要工具，以及促进基于统计的知识型管理所需的必要文化变革。
