Method Validation Plan & Report Template

Overview

Clause 7.2.2 requires validation of non-standard methods, laboratory-developed methods, and standard methods used outside their intended scope.

Key Parameters to Validate

• Selectivity: Can the method distinguish the analyte from interferences?
• Limit of Detection (LOD): What is the lowest level that can be detected?
• Limit of Quantitation (LOQ): What is the lowest level that can be quantified?
• Range & Linearity: What is the working range? Is the response linear?
• Repeatability: Precision under the same conditions (same operator, same day).
• Reproducibility: Precision under different conditions (different operator, different day).
• Bias / Trueness: How close is the result to the true value (using CRMs)?
• Robustness: Can the method withstand small changes in parameters (e.g., temperature, pH)?

How to Use

1. Plan: Define which parameters need validation and the acceptance criteria.
2. Execute: Perform the experiments.
3. Analyze: Calculate the statistics (SD, %RSD, recovery).
4. Conclude: Does the method meet the criteria? Is it fit for purpose?