Transcription of Method Validation - pfigueiredo.org
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Method Validation - pfigueiredo.org
ZIntroduction zStrategy for Validation of methods zValidation of Standard methods zRevalidation zParameters for Method Validation zSelectivity/specificity zPrecision and Reproducibility zAccuracy and recovery zLinearity and calibration curve zRange zLimit of Detection and Quantitation zRobustness zReferences go back to top Please Note: For convenient and trouble free implementation you can download a standard operating procedure for Method Validation from the Users Club section. Introduction Method Validation is the process to confirm that the analytical procedure employed for a specific test is suitable for its intended use. methods need to be validated or revalidated zbefore their introduction into routine use zwhenever the conditions change for which the Method has been validated, , instrument with different characteristics zwhenever the Method is changed, and the change is outside the original scope of the Method .
1. Develop a validation protocol or operating procedure for the validation 2. Define the application, purpose and scope of the method 3. Define the performance parameters and acceptance criteria
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