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Case Study: Requirements for analytical method development and validation

Requirements for analytical method development and validation.
Female scientist conducting an experiment in a laboratory
Analytical methods in the food system are used to determine if there is a contaminant present in the feed or food stuff. It is important to ensure analysis methods are validated as fit for purpose.
A number of analytical methods are validated in the European Commission decision 2002/657. The validation allows the user to determine and demonstrate the methods performance and to challenge the method. This allows the user to verify the result for legal implications and assure the correct results are retrieved from a particular method.
The key validation parameters or performance characteristics of a method are outlined in the following table:
Performance CharacteristicDescription
AccuracyCloseness of agreement between the average value obtained from a large series of test results and an accepted reference value
PrecisionExpresses the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogenous sample
SpecificityThe ability to assess indisputably the target analyte in the presence of components which may be expected to be present (such as impurities)
Limit of Detection (LOD)The lowest amount of analyte in the sample which can be detected but not necessarily quantified as an exact value
Limit of QuantificationThe lowest amount of analyte in the sample which can be quantitatively determined with suitable precision and accuracy
LinearityThe ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of the analyte in the sample
RangeThe interval between the upper and lower concentration (amounts) of analyte in the sample for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity
RobustnessShows the reliability of an analysis with respect to deliberate variations in method parameters
StabilityThe degree to which the substance is subject to degradation in time

Purpose of Validation

If we get a positive result: To be able to conclude with confidence that the target analyte is present in the sample at or above the legal limit
If we get a negative result: To be able to conclude with confidence that if the analyte is present at all then it must be below the legal limit or undetectable at ‘as low as reasonable achievable’ (ALARA).

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