Bioanalytical Method Validation: A Quality Assurance Auditor View Point
Journal Title: Journal of Pharmaceutical Sciences and Research - Year 2009, Vol 1, Issue 3
Abstract
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, reliableand 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. Anideal 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 beencountered 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 thebackground and principles of the bioanalytical method validation will help the quality assurance personnel to perform their duties in a most effective and focused manner.
Authors and Affiliations
Rama Rao Kalakuntla , Santosh Kumar K
Keywords
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