Chromatographic Method Validation: A Review of Current Practices and Procedures. III. Ruggedness, Re-Validation and System Suitability

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.