Validating chromatographic

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.

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.

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.

Satisfactory results for a method can be obtained only with equipment that is performing well.

Special attention should be paid to those equipment characteristics that are critical for the method.

This primer gives a review and a strategy for the validation of analytical methods for both methods developed in-house as well as standard methods, and a recommendation on the documentation that should be produced during, and on completion of, method validation.The AOAC (15) has developed a Peer-Verified Methods validation program with detailed guidelines on exactly which parameters should be validated.Winslow and Meyer (16) recommend the definition and application of a master plan for validating analytical methods. Breaux and colleagues have published a study on analytical methods development and validation (17).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.

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