Methodvalidatie

Methodvalidatie is the systematic process of verifying and documenting that a method used for measuring the properties of a substance or detecting a particular component is reliable, accurate, and suitable for its intended purpose. The concept originated in laboratory quality assurance and has become a cornerstone in analytical chemistry, pharmaceutical analysis, environmental testing, and other scientific disciplines. In many regulatory regions, such as the European Union, the United States, and Japan, methodvalidation is a legal requirement for any method that will be used to support regulatory submissions.

The validation process typically covers several key performance attributes. Accuracy refers to the closeness of the test results to the true value. Precision, or repeatability, indicates the consistency of results when the test is performed under identical conditions. Linearity assesses how well the method’s response correlates with the analyte concentration over a specified range. Specificity evaluates whether the method can unequivocally assess the analyte in the presence of potential interferences. Robustness examines the effect of small deliberate variations in method parameters on performance. Limits of detection and quantitation determine the smallest amount of analyte that can be reliably measured.

Validation studies generate a validation report that documents the experimental design, results, conclusions, and any deviations from the protocol. Once validated, a method may be used for routine analysis, but revalidation may be necessary if significant changes occur, such as new instrumentation, altered sample matrices, or updates in regulatory guidance. Methodvalidatie remains essential to ensure that analytical data are trustworthy, reproducible, and compliant with industry standards.