Chromatographic Method Validation: A Review of Current Practices and Procedures. Part II. Guidelines for Primary Validation Parameters

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 revalidation of analytical methods is discussed, strategies for the effective development and utilization of system suitability tests are described and the term "stability indicating" is defined. †Previously published in J. Liq. Chrom. & Rel. Technol., 19(12), 1873-1891 (1996).