engleski

Why and how to validate the method

Method validation is an important requirement for analytical laboratories working on a contract basis for customers. During the process of method validation the performance characteristics and the limitations of a method are established. Beside that, the influences which may change its performance characteristics are identified. Method validation is the process of verifying that a method is fit for solving a particular analytical problem, which is achieved by validation of the method performance and the estimation of the uncertainty of the results at a given level of confidence. Chemical laboratories accredited for a specific analytical task should demonstrate to the accreditation body and/or to the customers that they produce correct results and should be able to justify their correctness by using validated methods. The presentation on how to validate the method will be based on the concise statement brought out by recently published international standard ISO/IEC 17025 that the validation shall be as extensive as is necessary to meet the needs of the given application or field of application. The laboratory shall record the results obtained, the procedure used for the validation, and a statement as to whether the method is fit for the intended use.

validation of test methods

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