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新版GMP下沸腾干燥机控制系统设计

Dryer Control System Boiling under the New GMP
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摘要 在新版GMP(2011版)要求下,对沸腾干燥机的控制系统在工艺程序和控制方式上重新设计。并将控制系统设计为一个封闭的控制系统,结合实际设备情况,提出一种符合GMP文件管理的电子记录实用简便的解决方法。 Under the new version of GMP (2011 Edition) requires the boiling dryer control system in process redesign and control procedures. And the control system is designed as a closed control system, combined with the actual equipment, the proposed electronic records GMP document management solutions to meet the practical and easy.
出处 《可编程控制器与工厂自动化(PLC FA)》 2015年第5期55-56,51,共3页 Programmable controller & Factory Automation(PLC & FA)
关键词 沸腾干燥机 GMP 封闭系统 电子记录 Boiling dryer GMP Closed system Electronic records
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  • 1丁开云.控制系统GMP验证中的21 CFR Part 11相关性评估[J].世界仪表与自动化,2006,10(5):71-72. 被引量:2
  • 2Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 11, Electronic Records; Electronic Signatures; Final Rule, March 20, 1997.
  • 3FDA Guidance for Industry, Part 11, Electronic Records; Electronic Signatures-Scope and Application, U.S. Department of Health and Human Services, Food and Drug Administration, CDER, August 2003.

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