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Validating material

For example, if the method is to be run on a specific instrument in a specific laboratory, there is no need to use instruments from other vendors or to include other laboratories in the validation experiments.

In this way, the experiments can be limited to what is really necessary. Validation parameters for specific tasks The validation experiments should be carried out by an experienced analyst to avoid errors due to inexperience.

Hokanson (9,10) applied the life cycle approach, developed for computerized systems, to the validation and revalidation of methods.It is not always necessary to validate all analytical parameters that are available for a specific technique.For example, if the method is to be used for qualitative trace level analysis, there is no need to test and validate the method’s limit of quantitation, or the linearity, over the full dynamic range of the equipment.Successful acceptance of the validation parameters and performance criteria, by all parties involved, requires the cooperative efforts of several departments, including analytical development, QC, regulatory affairs and the individuals requiring the analytical data.The operating procedure or the Validation Master Plan (VMP) should clearly define the roles and responsibilities of each department involved in the validation of analytical methods.Table 2 gives examples of which parameters might be tested for a particular analysis task.The scope of the method should also include the different types of equipment and the locations where the method will be run.Initial parameters should be chosen according to the analyst’s experience and best judgment.Final parameters should be agreed between the lab or analytical chemist performing the validation and the lab or individual applying the method and users of the data to be generated by the method.The validation procedure in this particular article is based on requirements for EU multistate registration.Wegscheider (13) has published procedures for method validation with a special focus on calibration, recovery experiments, method comparison and investigation of ruggedness. (14) have described how analytical methods are validated in a Japanese QC laboratory.

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