General considerations for the analytical method validation process

The development and production of drugs within the pharmaceutical industry requires manufacturers to quantify their components, and this entails the use of an analytical method that must first be validated in order to be implemented. Validation refers to documented evidence that a process is suitable for the intended method and can replicate consistent results, which establishes scientific evidence that the process is capable of consistently producing a quality product. The parameters evaluated during the validation of an analytical method are specificity, linearity, limits of detection, limits of quantification, range, accuracy and precision. 

To carry out the validation process, it is recommended a team is formed that includes experts from different areas who can contribute knowledge from different perspectives. Another important point is to plan and carry out the validation process following scientific principles. In addition, in the validation life cycle of a process or analytical method, a risk analysis of the parameters and everything that could have an impact on the product or the material in process should be used to establish appropriate controls over everything that represents a risk; these risks should be reevaluated each time new information is issued. Finally, validation should ensure that the process is reasonably protected against anything that could represent a source of variability.