Do we agree with liquid chromatograph operational qualification provided from manufacturers?

被引:0
|
作者
Quintela Bermejo, Manuel [1 ]
Baguena Polo, Judith [1 ]
Gotor Navarra, Gemma [1 ]
Blanco Roca, Maria Josefa [1 ]
Broto Puig, Francesc [1 ]
机构
[1] Univ Ramon Llull, IQS Inst Quim Sarria, Barcelona, Spain
关键词
equipment qualification; operational qualification; analytical instrument qualification; liquid chromatography;
D O I
暂无
中图分类号
O6 [化学];
学科分类号
0703 ;
摘要
Good manufacturing practices include the concept of equipment qualification which aims to demonstrate in a documented way that equipment operates correctly for its intended use and that it is properly maintained and calibrated. Equipment qualification is the base to generate quality data and is formed by four phases: Dq, IQ, OQ and PQ. This article presents how to carry out OQ for a liquid chromatograph. A proposed OQ for a liquid chromatograph is based on a variety of tests that evaluate equipment from a modular point of view. There have also been discussed and set appropriate acceptance criteria whose selection has been based on a search and examination of the criteria used by manufacturers and an exhaustive study of equipment historical results.
引用
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页码:6 / 12
页数:7
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