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17.4 Method Validation

References - The Valida1on Process - There are numerous publica1ons addressing this issue. Following are some references you may find useful :

❏ Trace Analysis: A structured approach to obtaining reliable results; Prichard, E., Mackay, G. M., Points, J., Eds.; The Royal Society of Chemistry: 31-39; 1996.

❏ A Practical Guide to Method Validation; Green, J. Mark, Ed.; Analytical Chemistry (68): 305A-309A; 1996.

❏ Swartz, Michael E.; Krull, Ira S. Analytical Method Development and Validation; Marcel Dekker, Inc.: 1997.

17.5 Method Validation

Confirm Basic Performance Criteria :

❏ The method must 'fit the purpose' as agreed upon between the client and the analyst. ❏ In the case of trace analysis, the criteria described in the following slides are typically evaluated as part of the method development process.