Chromatographic Method Validation: A Review of Current Practices and Procedures. III. Ruggedness, Re-Validation and System Suitability
作者:
DennisR. Jenke,
期刊:
Journal of Liquid Chromatography & Related Technologies
(Taylor Available online 1996)
卷期:
Volume 19,
issue 12
页码: 1873-1891
ISSN:1082-6076
年代: 1996
DOI:10.1080/10826079608014012
出版商: Taylor & Francis Group
数据来源: Taylor
摘要:
Validation of analytical methodologies is an important aspect of their development/utilization and is widely required in support of industrial product development and registration. In this manuscript, ruggedness as a validation parameter is considered in terms of its definition, appropriate evaluation procedures and acceptance criteria. Additionally, the re-validation of analytical methods is discussed, strategies for the effective development and utilization of system suitability tests are described and the term “stability indiating” is defined.
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