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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.

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.

Representatives of the pharmaceutical and chemical industry have published papers on the validation of analytical methods.

Hokanson (9,10) applied the life cycle approach, developed for computerized systems, to the validation and revalidation of methods.

The preparation and execution should follow a validation protocol, preferably written in a step-by-step instruction format.

Possible steps for a complete method validation are listed in Table 1.




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