The importance of analytical validation

Analytical validation is the process of assessing and establishing the reliability, accuracy, precision and other performance characteristics of an analytical method or test. It is an essential step in the development and implementation of any analytical procedure, whether it is used in research, clinical diagnostics, pharmaceuticals or other industries. Find out in the article below more about this process!

The aim of analytical validation is to ensure that the analytical method produces consistent and valid results, indicates stability and fulfils the intended purpose and requirements of the application. This validation process involves several parameters and performance criteria, including:

1. Precision: Determines how close the test results are to the true value or a reference standard.

2. Precision: Assesses the reproducibility and repeatability of the method by measuring the variation between multiple measurements from different people or equipment of the same sample.

3. Sensitivity: Measures the ability of the method to detect small changes in the concentration or property of the analyte.

4. Specificity: Determines the ability of the method to accurately measure the target analyte without interference from other substances.

5. Linearity: Assesses the ability of the method to produce results directly proportional to the analyte concentration.

6. Limit of detection (LOD) and limit of quantification (LOQ): LOD is the lowest concentration or amount of analyte that can be reliably detected, while LOQ is the lowest concentration or amount that can be quantified with acceptable accuracy and precision.

7. Robustness: Assesses the reliability and performance of the method under various conditions such as changes in temperature, pH or equipment and is therefore an indicator of stability.

Analytical validation typically involves performing tests, analysing samples with known concentrations or properties, comparing the results with reference methods or standards, and evaluating the performance of the method against predefined acceptance criteria. These validation processes may vary depending on the nature of the analytical method, regulatory requirements and the intended use of the method but, as we have seen, analytical validation is fundamental in assessing and confirming the reliability, accuracy, precision and other performance characteristics in an analytical method or assay.

Only in this way can it be ensured that the data generated is precise, accurate and provides a result in line with the objectives of the process. This is why RC REDOL is well equipped to help your company with all analytical validation processes. In fact, our specialised technicians can guide your processes to achieve the required accuracy and robustness objectives and, with our input, you will be able to develop or produce medicines safely and in compliance with customer requirements, legal obligations and market and regulatory authority demands. Contact us and find out how!

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