ISO 17025 Method Validation Checklist for Pharmaceutical Testing

Key validation parameters typically include accuracy, precision (repeatability and intermediate precision), specificity, linearity, range, limit of detection (LOD), limit of quantitation (LOQ), robustness, and, where applicable, stability of analytical solutions.

ISO 17025 does not specify a fixed revalidation frequency. However, methods should be revalidated when significant changes occur, such as modifications to the method, changes in equipment or reagents, or when quality control data indicate performance issues. A periodic review of method performance is also recommended.

Method validation is typically performed by qualified analytical chemists or method development specialists. However, the overall responsibility for ensuring proper validation lies with the laboratory manager or quality assurance manager, who should review and approve validation protocols and reports.

The checklist includes items to ensure that measurement uncertainty is estimated and documented as part of the method validation process. This includes considering all significant sources of uncertainty and evaluating their impact on the overall measurement result, as required by ISO 17025.

Yes, while the specific validation parameters may vary, this checklist is designed to be applicable to both chemical and microbiological testing methods. It includes general principles of method validation that can be adapted to different types of analytical procedures used in pharmaceutical laboratories.