ABSTRACT

Validation is one of the most important steps of the analytical procedures to be put into practice. In particular, it allows one to define analytical methodology. On the basis of designated, in the process of validation parameters, it is possible to determine the suitability of the (range) of the methodology and make it an optimal choice. One describes a process validation of the analytical procedure—an element of the QA/QC system. The role and importance of the validation of analytical procedures in obtaining reliable measurement results is presented. Each validation parameter is defined and described. Detailed information about determination and calculation of validation parameters, supported by appropriate examples, are presented in this chapter.