Chromatographic Method Validation: A Review of Current Practices and Procedures. I. General Concepts and Guidelines

Abstract Validation of analytical methodologies is widely recognized as an important aspect of the development/utilization of analytical procedures and is widely required in support of product registration applications. Detailed, specific and comprehensive guidelines for the performance of analytical validations are not universally available. In this manuscript, the role and concept of validation is defined, the necessity for validation is established and published guidelines related to appropriate validation parameters are reviewed. The validation of chromatographic methods for pharmaceutical applications is particularly emphasized.