Bioanalytical Method Validation: A Quality Assurance Auditor View Point

ISSN:0975-1459 Bioanalytical method validation includes all of the procedures that demonstrate that a particular method used for a quantitative measurement of analytes in a given biological matrix is selective, sensitive, reliable and reproducible for the intended use. Any method developed for the analysis of analytes in biological fluids must yield consistent results despite the variations in conditions during the course of a project. An ideal bioanalytical method should include all of the probable effects that are going to occur during the routine analysis of study samples. It may not be possible to test each and every condition that is going to be encountered during the subject sample analysis. However, it should include all the applicable regulatory specified validation parameters and should assure the integrity of the study data. Some of the proposals were made to the validation procedure to encounter the possible situations in the routine study sample analysis. An attempt has been made to understand and explain the bioanalytical method validation for chromatographic assays from the quality assurance auditor viewpoint. A good understanding of the background and principles of the bioanalytical method validation will help the quality assurance personnel to perform their duties in a most effective and focused manner. ________________________________________________________________________