Methods in validating tests

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.The key point is to develop methods for easy validation and revalidation. Krause published a guide for analytical method transfer, comparability, maintenance and acceptance criteria for the testing of biopharmaceuticals (18).

The label includes safety warnings, required information for controlled substances, and calculation values for standards with quantitative applications. Where necessary, USP Reference Standards are shipped with additional technical data sheets.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).Users must ascertain that the Reference Standards they are using are a "Current lot" or a "Previous lot" within the valid use date.Current and previous lot information is available in the Reference Standards listings and catalog.

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It also describes what is important when transferring a method.

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