PRACTICAL METHOD VALIDATION - VALIDATION SUFFICIENT FOR AN ANALYSIS METHOD

Validation of an analysis method depends on the purpose of the method, the chosen technique and the procedure in question. Methods are used for different research, product development, process control and quali ty control purposes. The human and economical importance of results va ry. Each of the techniques used, such as chromatography-(HPLC, HRGC, T LC), capillary electrophoresis-(CE), spectrophotometry-(UV/VIS, IR, fl uorescence, AAS, ICP) or spectrometric techniques (NMR, MS) as well as the hyphenated methods, have their own special features and deficienc ies which must be considered. The method can include a simple pretreat ment or it may include many demanding steps, it can use automation and data processing in various ways, it can have an official status, it c an be a thoroughly verified or less studied one. How should these diff erences be accounted for during the validation? What would be a suffic ient certainty that the method does what is expected, that the method fits for the purpose it was intended? The client (or authority) decide s the required timetable, cost and quality level. This is why within a laboratory different quality levels and associated levels of validati on exist. This paper tries to outline a practical test frame for valid ation efforts to assist the analyst when planning validation of a meth od.